Evaluation of the Puritan Bennett™ 980 Ventilator System Safety and Performance in the Real-World Setting

Abstract

Purpose
Mechanical ventilation is a life-supporting intervention but is associated with known risks and complications. To improve the efficacy and safety profile of mechanical ventilation, manufacturers have developed advanced ventilator settings, modes, and alarm strategies to optimize ventilation for patient needs while avoiding complications. However, there is little real-world data published on the deployment of ventilator technology. The main objective of this study was to assess the clinical safety and performance of the Puritan Bennett™ 980 Ventilator System (PB980) using real-world clinical data collected from a diverse, global patient population.

Methods
This was a multi-center, post-market registry study that included nine sites: four in the United States of America, one in Europe, and four in China. Patients were enrolled into the registry if they were intended to be treated with a PB980. Data collection began at the start of ventilation and continued until extubation off the ventilator or up to seven days of ventilation, whichever occurred first. Subjects were divided by age into three categories: infants (0–365 days), pediatric (1–17 years), and adult (18 years and older). The primary outcome was device-related complication rate.

Results
Two-hundred-and-eleven subjects were enrolled (41 infants, 48 pediatric, and 122 adults). Sixteen deaths, unrelated to device deficiency, occurred during the data collection timeframe (relative frequency: 7.58, 95% CI: 4.40, 12.0). Only one device-related adverse event was reported (relative frequency: 0.47% 95% CI: 0.01%, 2.61%).

Conclusion
Ventilation by the PB980 was delivered safely in this multi-center observational study, which included a diverse sample of patients with broad ventilatory needs.

Full text

ORIGINAL RESEARCH
Evaluation of the Puritan Bennett™ 980 Ventilator
System Safety and Performance in the Real-World
Setting
Michael Roshon
1
, Paras B Khandhar
2
, Manoj Biniwale
3
, Rangasamy Ramanathan
3
, T Patrick Frazier
4
,
Feng Xu
5
, Linlin Zhang
6
, Xiangdong Guan
7
, Dai Wenling
8
, Bernard Lambermont
9
1
Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado, Springs, CO, USA;
2
Pediatric Critical Care Medicine, Beaumont
Children’s Hospital, Royal Oak, MI, USA;
3
Division of Neonatology, University of Southern California Keck School of Medicine, Los Angeles, CA, USA;
4
Department of Medicine, University of Alabama at Birmingham, Heersink School of Medicine, Birmingham, AL, USA;
5
Department of Intensive Care,
Children’s Hospital of Chongqing Medical University, Chongqing, People’s Republic of China;
6
Department of Critical Care Medicine, Beijing Tiantan
Hospital, Capital Medical University, Beijing, People’s Republic of China;
7
Department of Critical Care Medicine, the First Afliated Hospital of Sun
Yat-Sen University, Guangzhou, People’s Republic of China;
8
Department of Critical Care Medicine, Yancheng First People’s Hospital, Yancheng,
People’s Republic of China;
9
Department of Intensive Care, University Hospital of Liege, Liege, Belgium
Correspondence: Michael Roshon, Email MichaelRoshon@Centura.Org
Purpose: Mechanical ventilation is a life-supporting intervention but is associated with known risks and complications. To improve
the efcacy and safety prole of mechanical ventilation, manufacturers have developed advanced ventilator settings, modes, and alarm
strategies to optimize ventilation for patient needs while avoiding complications. However, there is little real-world data published on
the deployment of ventilator technology. The main objective of this study was to assess the clinical safety and performance of the
Puritan Bennett™ 980 Ventilator System (PB980) using real-world clinical data collected from a diverse, global patient population.
Methods: This was a multi-center, post-market registry study that included nine sites: four in the United States of America, one in
Europe, and four in China. Patients were enrolled into the registry if they were intended to be treated with a PB980. Data collection
began at the start of ventilation and continued until extubation off the ventilator or up to seven days of ventilation, whichever occurred
rst. Subjects were divided by age into three categories: infants (0–365 days), pediatric (1–17 years), and adult (18 years and older).
The primary outcome was device-related complication rate.
Results: Two-hundred-and-eleven subjects were enrolled (41 infants, 48 pediatric, and 122 adults). Sixteen deaths, unrelated to device
deciency, occurred during the data collection timeframe (relative frequency: 7.58, 95% CI: 4.40, 12.0). Only one device-related
adverse event was reported (relative frequency: 0.47% 95% CI: 0.01%, 2.61%).
Conclusion: Ventilation by the PB980 was delivered safely in this multi-center observational study, which included a diverse sample
of patients with broad ventilatory needs.
Plain Language Summary: Mechanical ventilation is a life supporting intervention. Much progress has been made in this eld
thanks to a better knowledge of respiratory physiopathology and improved ventilation delivered by modern ventilators.
In this global, post-market registry study, ventilation by the Puritan Bennett™ 980 Ventilator was delivered safely to a diverse
sample of patients.
Keywords: ventilation, PB980, safety, complications, respiratory distress, critical care
Introduction
Mechanical ventilation is a life-supporting intervention for patients with respiratory failure or critical illness. However,
mechanical ventilation also carries the risk of signicant complications, including ventilator-associated pneumonia,
neuromuscular weakness from sedative therapies, volutrauma, and barotrauma.
1,2
Ventilation devices have advanced to
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open access to scientific and medical research
Open Access Full Text Article
Received: 8 August 2023
Accepted: 12 January 2024
Published: 23 January 2024

employ a variety of settings and modes that can be manipulated in response to patient ventilation needs to improve the
efcacy and safety prole.
3–5
Ventilator design has become more sophisticated and rened over the past century, with improvements from negative-
pressure ventilators that required the patient’s entire body to be encased in the 19th and early 20th centuries to today’s
positive-pressure ventilators that boast a plethora of settings and modes to provide responsive ventilation to a large
spectrum of patient needs.
6,7
Ventilation solutions are intended to protect the airway and support the pulmonary system
while minimizing ventilator-induced complications.
8
To optimize patient safety and comfort, ventilator advancements
aim to make mechanical ventilation synchronous with patient demands and less intermittent mandatory delivery of
positive pressure.
The Puritan Bennett™ 980 Ventilator System (PB980) is a CE-marked and FDA-cleared medical device designed to
provide continuous ventilation for patients who require respiratory support, delivered via invasive mechanical ventilation
(IMV) or noninvasive ventilation (NIV). Care can be administered to neonatal, pediatric, and adult patients weighing at
least 0.3 kg, with tidal volumes for mandatory volume-controlled breaths from 2 mL to 2500 mL. The PB980 is intended
for use in hospitals, and intra-hospital transport.
Several bench studies have been published utilizing lung models to simulate a variety of ventilation needs to support
the safety and performance of the PB980.
9–16
However, despite the advances in ventilator technology, real-world
experience and the safety performance of these devices have yet to be fully explored in the medical literature.
The PB980 Post-Approval Registry study aimed to assess the clinical safety and performance of the PB980 using
real-world clinical data collected from a diverse, global patient population. The primary objective was to obtain direct
clinical evidence to support the safety of the ventilator system.
Materials and Methods
Study Design
Data was collected from the PB980 Post-Approval Registry, a prospective, observational, multinational study conducted
from June 2020 to April 2022 in the United States of America (USA), Europe, and China (Table 1). Enrollment in the
study did not impact the care patients received before, during, or after participation. Study procedures were performed in
accordance with the Declaration of Helsinki under a protocol that was duly approved by the Institutional Review Board
or Ethics Committee (IRB/EC), as applicable, at each site. This study was sponsored and supported by Medtronic
(Minneapolis, MN).
Table 1 Participating Sites and Enrollments
Site Information Enrollments
Site Name Country Adult Pediatric Infant
Penrose-St. Francis Health Services, Colorado Springs, Colorado USA 70 0 0
Beaumont Children’s Hospital, Royal Oak, Michigan USA 4 25 10
Los Angeles General Medical Center, Los Angeles, California USA 0 9 21
University of Alabama at Birmingham, Birmingham, Alabama USA 17 0 0
Children’s Hospital of Chongqing Medical University, Chongqing China 0 6 10
Beijing Tiantan Hospital, Capital Medical University, Beijing China 15 0 0
The First Afliated Hospital of Sun Yat-Sen University, Guangzhou China 11 0 0
Yancheng First People’s Hospital, Guangzhou China 0 8 0
University Hospital of Liege, Liege Belgium 5 0 0
Total 122 48 41
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Patient and Procedures
Patients receiving IMV or NIV using the PB980, as ordered by the treating physician, were eligible for study enrollment.
Enrollment took place prior to ventilation or up to 30 days following the start of ventilation. Data were collected for the
duration of mechanical ventilation to extubation or seven ventilation days, whichever occurred rst.
Subjects were divided based on age into three cohorts: infants (0–365 days), pediatric (1 year – 17 years), and adult (18
years and above). Due to the population under study, many subjects presented with trauma and/or were intubated, therefore
a variety of methods were used to obtain consent. Per local IRB/EC requirements, consent was obtained in one of the
following ways, depending on clinical situation: 1) prior to receiving care, 2) after receiving care (up to 30 days following
start of ventilation), or 3) waiver of consent. Waiver of consent was provided at the discretion of each site’s IRB/EC, with
only sites in the USA utilizing this option. For pediatric subjects who were not enrolled under waiver of consent, assent and
parental and/or guardian consent was obtained, per local IRB/EC requirements. For infant subjects, who were not enrolled
under waiver of consent, parental and/or guardian consent was obtained.
The PB980 Post-Approval Registry was designed to collect real-world clinical data on various patients using the
ventilator as intended for routine medical care. Ventilator settings were managed by the attending clinician(s), as
determined by patient clinical need and routine care. Trained research staff recorded ventilator settings every four
hours for the duration of ventilation or up to seven ventilation days, whichever occurred rst. All system-related adverse
events and device deciencies that occurred during the data collection period were promptly reported.
Data Collection
The primary endpoint was dened as the device complication rate of the PB980 during the duration of the study.
Complications were dened as any event related to the ventilator or the ventilation therapy that impacted the patient
during study participation. Site investigators assessed all complications and complication details, and investigator-
determined relatedness was reported to the study sponsor and IRB/EC, as applicable.
In addition to the primary endpoint, subject demographics, including age, sex, weight, and height were collected.
A brief medical history was obtained by reviewing the medical record to determine the history or presence of brain/
neurological disease, cardiac disease, diabetes, renal disease, respiratory disease, stroke, or musculoskeletal disease.
Admission diagnosis and reason for surgery, if applicable, were noted, along with an indication for respiratory
intervention. The type of ventilation mode, endotracheal tube use, date and time of initial ventilation, date and time of
extubation, and date and time of admission to and discharge from the intensive care unit were also recorded. Ventilation
settings were collected every four hours and included ventilation type, ventilation mode, fractional inspired oxygen
(FiO
2
), blood oxygen saturation (SpO
2
), tidal volume, peak inspiratory pressure, inspiration time, and positive end-
expiratory pressure (PEEP). Additionally, physiologic measures were collected every four hours and included respiratory
rate, heart rate, and blood gas results, if available, including blood pH, partial pressure of carbon dioxide (PaCO
2
), partial
pressure of oxygen (PaO
2
), and bicarbonate (HCO
3
). Reason for study exit, including death, was also collected.
Statistical Analysis
The data was analyzed using SAS© statistical software, Version 9.4 (TS1M7) (SAS Institute Inc., Cary, NC, USA).
Categorical variables are presented as counts and percentages. Descriptive statistics are provided for continuous variables.
As this was an observational study, no treatment groups were assigned, or statistical signicance testing completed.
A minimum sample size of 160 subjects total, with at least 30 subjects in each cohort, was determined necessary to
detect a complication rate between 5% and 10%, with a precision of 1.7% to 2.4% standard error. This sample size
allowed for a 95% chance of detecting a complication rate as low as 2%.
Results
Participants
Two-hundred-eleven subjects were enrolled in the registry across the three age groups (Table 2), exceeding the minimum
sample size calculated to achieve study goals. The most commonly reported medical history in adult subjects included
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cardiac, brain/neurological, and respiratory disease (Table 3). Pediatric patients most frequently reported brain/neurolo-
gical disease and respiratory disease, while infants most commonly had a history of respiratory disease. Across all three
age cohorts, the most common indication for ventilation was related to presenting medical conditions as opposed to
trauma or surgery.
Procedural Characteristics
Only one device-related complication was reported during the study across all 211 subjects (relative frequency: 0.47%,
95% CI: 0.01%, 2.61%). The device deciency occurred in a 56-year-old female who presented with trauma due to a fall.
At baseline, the patient had an ASA status of 4 and a medical history positive for brain or neurological disease,
respiratory disease, and musculoskeletal disease. The subject received IMV using the PB980 20 days after initial
admission to the intensive care unit, after being transferred from another ventilator (no data collection occurred while
Table 2 Subject Characteristics
Variable Category Adults Pediatric Infant
Age (Years: Adult,
Pediatrics; Days: Infant)
n 122 48 41
Mean±SD 56.8±17.7 6.1±4.5 63.6±97.9
Median 59.0 4.5 21.0
95% CI of Mean [53.7, 60.0] [4.78, 7.41] [32.7, 94.5]
Range 19–87 1–17 0–365
Sex n 122 48 41
Male 68 (55.7%) 27 (56.3%) 26 (63.4%)
Female 54 (44.3%) 21 (43.8%) 15 (36.6%)
Weight (kg) n 117* 48 41
Mean±SD 79.35±23.87 24.70±18.23 3.82±2.43
Median 75.00 17.40 83.40
95% CI of Mean [75.0, 83.7] [19.4, 30.0] [3.07, 4.57]
Range 28.9–152.0 9.0–80.3 0.7–13.5
Note: *Weight is missing for ve subjects.
Abbreviations: SD, standard deviation; CI, condence interval.
Table 3 Subject Medical History and Indication for Ventilation
Medical History Adults (N=122) Pediatric (N=48) Infants (N=41)
Brain Or Neurological Disease 57 (46.7%) 20 (41.7%) 6 (14.6%)
Cardiac Disease 60 (49.2%) 2 (4.2%) 9 (22.0%)
Diabetes 24 (19.7%) 0 (0.0%) 1 (2.4%)
Musculoskeletal Disease 24 (19.7%) 13 (27.1%) 4 (9.8%)
Renal Disease 27 (22.1%) 1 (2.1%) 0 (0.0%)
Respiratory Disease 49 (40.2%) 16 (33.3%) 23 (56.1%)
Stroke 16 (13.1%) 0 (0.0%) 0 (0.0%)
Indication for Ventilation
Medical Reason 90 (73.8%) 31 (64.6%) 28 (68.3%)
Post-Operative 14 (11.5%) 7 (14.6%) 12 (29.3%)
Trauma 18 (14.8%) 10 (20.8%) 1 (2.4%)
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receiving ventilation support using non-PB980 ventilator). While the subject was on the PB980, the most common
ventilation setting used was spontaneous mode set to PAV+ and ow trigger mode. The complication was an expiratory
lter blockage that occurred after the subject had been on the PB980 for approximately one day. The ventilator alarm
appropriately indicated an expiratory lter warning, and the subject was immediately transferred to another ventilator
(not PB980) to avoid further obstruction. The blockage did not appear to result in any short or long-term detriment to the
subject’s health and did not prolong hospital length of stay. Sixteen deaths (relative frequency: 7.58, 95% CI: 4.40, 12.0),
none related to device deciency, occurred during the study (Table 4). Reported reasons for death included: respiratory
failure (n=6), cardiogenic shock (n=3), sepsis (n=1), stroke (n=1), cardiac arrest (n=1), and incomplete description given
(n=4). Six patients were reported to have been removed from the ventilator as part of comfort care.
The most frequently used ventilator settings during study enrollment are presented in Table 5. All pediatric and adult
subjects, except one, received IMV, whereas approximately half of the infants received NIV. During the study period, three
adults and two infants were noted to have alternated between IMV and NIV. The most frequently used ventilator settings are
reported. Assist control was the most frequently reported breath control mode for adult patients, while pediatric and infant
patients were most frequently treated using synchronized, intermittent mandatory ventilation (SIMV). SIMV mode is
Table 5 Most Frequently Used Ventilator Settings by Age Group
Parameter Setting Adult (N=122) Pediatric (N=48) Infant (N=41)
Ventilation Type Invasive 120 (98.4%) 48 (100.0%) 22 (53.7%)
Non-Invasive 1 (0.8%) 0 (0.0%) 19 (46.3%)
Missing 1 (0.8%) 0 (0.0%) 0 (0.0%)
Ventilator Mode
Breath Control Assist Control 87 (71.3%) 12 (25.0%) 4 (9.8%)
Bi-Level 3 (2.5%) 0 (0.0%) 0 (0.0%)
CPAP 0 (0.0%) 0 (0.0%) 5 (12.2%)
SIMV 16 (13.1%) 35 (72.9%) 32 (78.0%)
SPONT 16 (13.1%) 1 (2.1%) 0 (0.0%)
Breath Type
Mandatory Type Pressure Support 19 (15.6%) 9 (18.8%) 31 (75.6%)
Volume Control 51 (41.8%) 9 (18.8%) 2 (4.9%)
Volume Control Plus 37 (30.3%) 31 (64.6%) 7 (17.1%)
Spontaneous Type Pressure Support 36 (29.5%) 42 (87.5%) 40 (97.6%)
Trigger Type Flow Triggering 96 (78.7%) 45 (93.8%) 40 (97.6%)
IE Sync Triggering 1 (0.8%) 0 (0.0%) 0 (0.0%)
Pressure Triggering 7 (5.7%) 3 (6.3%) 0 (0.0%)
(Continued)
Table 4 Summary of Deaths Reported During Study
Statistic Adult (N=122) Pediatric (N=48) Infant (N=41) Total (N=211)
Count 12 3 1 16
Relative Frequency (%) 9.84 6.25 2.44 7.58
95% CI* [5.2, 16.6] [1.3, 17.2] [0.1, 12.9] [4.40, 12.0]
Note: *Clopper-Pearson method for exact binomial condence intervals. No reported deaths were associated with device
deciency.
Abbreviation: CI, condence interval.
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available for both IMV and NIV. Infants received pressure support more frequently than adult or pediatric patients. Flow
triggering was the most frequently used trigger type across all cohorts. Table 6 depicts physiologic measures collected
during study procedures and reects the range of physiologies and patient states included in this registry.
Table 5 (Continued).
Parameter Setting Adult (N=122) Pediatric (N=48) Infant (N=41)
Average FiO
2
n 122 48 41
Mean±SD 0.50±0.15 0.42±0.08 0.32±0.11
Median 0.45 0.41 0.30
95% CI of Mean [0.47, 0.52] [0.40, 0.45] [0.28, 0.35]
Range 0.21–1 0.26–0.62 0.21–0.75
Average PEEP (cm H
2
O) n 122 48 39
Mean±SD 6.5±2.3 5.6±1.7 5.4±1.4
Median 5.0 5.0 5.2
95% CI of Mean [6.09, 6.89] [5.10, 6.06] [4.97, 5.85]
Range 4.4–13.9 3.0–11.3 3.0–8.0
Note: For ventilation settings, the most frequently used ventilator setting during study enrollment is presented.
Abbreviations: SD, standard deviation; CI, condence inter val; CPAP, continuous positive airway pressure; SIMV, synchronized
intermittent mandatory ventilation; SPONT, spontaneous breathing mode; FiO
2
, fraction of inspired oxygen; PEEP, positive end-
expiratory pressure.
Table 6 Physiologic Measures by Age Group
Parameter Statistic Adult (N=122) Pediatric (N=48) Infant (N=41)
Average Respiratory Rate (breaths/min) n 122 48 41
Mean±SD 18.2±5.12 23.3±6.24 38.6±9.68
Median 17.0 23.3 39.9
95% CI of Mean [17.2, 19.1] [21.5, 25.1] [35.5, 41.6]
Range 10.0–34.0 11.3–41.4 18.8–60.0
Average SpO
2
(%) n 122 48 41
Mean±SD 97.2±2.81 98.7±1.44 96.9±2.04
Median 98.0 99.1 97.0
95% CI of Mean [96.7, 97.7] [98.3, 99.2] [96.3, 97.6]
Range 79.5–100.0 92.6–100.0 92.2–100.0
Average Heart Rate (beats/min) n 122 48 41
Mean±SD 86.1±14.55 115.4±23.06 140.6±14.95
Median 85.2 113.0 142.0
95% CI of Mean [83.4, 88.7] [108.7, 122.1] [135.9, 145.3]
Range 51.7–126.6 76.0–166.2 107.8–167.8
Average pH n 100 44 31
Mean±SD 7.39±0.106 7.35±0.130 7.41±0.075
Median 7.39 7.39 7.40
95% CI of Mean [7.37, 7.41] [7.31, 7.39] [7.38, 7.43]
Range 7.04–7.62 7.00–7.52 7.29–7.71
Average PaCO
2
(mmHg) n 100 44 31
Mean±SD 39.3±10.51 39.9±6.03 40.9±7.94
Median 37.7 39.0 40.7
95% CI of Mean [37.2, 41.4] [38.1, 41.8] [38.0, 43.8]
Range 14.3–85.0 23.3–53.6 25.0–58.0
(Continued)
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Discussion
Previous studies have explored ventilator safety and performance using lung models to simulate patient scenarios.
9–16
These studies have concentrated primarily on bench studies and have demonstrated superior or comparative performance
of the PB980 to other ventilators.
9–12,14,16
There is robust clinical literature examining patient outcomes and ventilator
use. However, less is explicitly reported on ventilator safety and performance in the clinical setting. Case reports have
documented ventilator malfunction and its effects on individual patient outcomes,
17–22
with some case reports speci-
cally describing ventilator lter blockage. In previous reports, lter blockage due to patient secretions led to bilateral
tension pneumothorax, presumably secondary to defective anesthesia breathing circuit lter.
23,24
If the lter on
a ventilator is obstructed, oxygen may not ow properly to the patient. Hypoxia can have serious adverse effects,
including death. Obstruction can be detected by the ventilator with changes in pressure which would cause the ventilator
to alarm. In response to the lter blockage during the current study, the alarm went off and the ventilator was changed,
resulting in no further complications.
Three studies examining reported ventilator-related adverse events using national registries found that the most
common cause for ventilator-related adverse events was associated with user error.
25–27
A large screen displaying
respiratory curves on the PB980 allows for monitoring and storing the curves during inspiratory and expiratory pauses,
allows for the calculation and monitoring of intrinsic PEEP, total respiratory system resistance, and compliance. Those
measurements can be helpful when determining the delivery of respiratory support. Data from the UK National Reporting
and Learning System (2006–2008) found that of the 1029 incidents, 17.9% were related to the ventilator, though specic
information about ventilator type, settings, or patient condition was not reported.
27
To our knowledge, this is the rst
study to report PB980 ventilator-related safety and performance as a primary outcome in a real-world setting on a large
sample of diverse patients.
Limitations
This study was designed to collect information on ventilator safety and performance and did not collect information on
additional clinical parameters or outcomes. This limits the clinical conclusions that can be derived from the data. Any
future study or expansion of the registry should include a collection of clinically relevant outcomes. Further, subjects
were only enrolled in the study if they received ventilation with the PB980 and only up to seven days of ventilation, thus
potentially excluding large swaths of ventilatory care provided to patients. Efforts were made to create a diverse sample;
however, the data do not include all patient or disease types who receive ventilation across the globe. Additionally, data
was collected every four hours with the most frequent ventilator settings reported, obscuring any changes to ventilation
settings that may have taken place between data collection intervals.
Table 6 (Continued).
Parameter Statistic Adult (N=122) Pediatric (N=48) Infant (N=41)
Average PaO
2
(mmHg) n 100 36 29
Mean±SD 119.7±59.06 130.3±58.56 80.9±33.60
Median 101.3 129.6 70.5
95% CI of Mean [107.9, 131.4] [110.5, 150.1] [68.1, 93.6]
Range 53.8–372.0 34.0–264.4 31.5–173.0
Average HCO
3
(mEq/L) n 99 43 31
Mean±SD 23.4±5.17 24.2±4.14 24.8±4.50
Median 23.5 23.5 23.9
95% CI of Mean [22.4, 24.5] [22.9, 25.5] [23.2, 26.5]
Range 9.5–37.7 10.3–34.0 18.0–36.0
Abbreviations: SD, standard deviation; CI, condence interval; SpO
2
, oxygen saturation; PaCO
2
, partial pressure of carbon dioxide; PaO
2
,
partial pressure of oxygen; HCO
3
, bicarbonate.
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Conclusion
Using real-world, global data, this study supports the safety and performance of the PB980 across a diverse group of
patients with a wide variety of ventilation settings and physiologic parameters.
Acknowledgments
Study execution support was provided by Katherine Schiller, Naomi Wang, Demarcus Williams, and Ryan Zhou of
Medtronic, Elizabeth Kring and Christine Batchelder of Beaumont Children’s, and Nathan Dureg and Kate Ramm of
University of Southern California General Medical Center. Biostatistical analysis and support was provided by Anne
Sexter, Guang Yang, Hui Xiong, and Julia Yang of Medtronic. Medical writing support was provided by Hanan Zavala of
Medtronic in accordance with Good Publication Practice (GPP 2022) guidelines.
28
An abstract of this work was accepted and presented at the Society of Critical Care Medicine 2024 Critical Care
Congress (January 21 – 23, Phoenix Arizona).
Disclosure
The study was sponsored and funded by Medtronic. All authors (or their institutions) received research support from
Medtronic to conduct this study.
Michael Roshon serves as a director on USACS’ National Clinical Governance Board.
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