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

Figures & data

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 Affiliated 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

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 five subjects.

Abbreviations: SD, standard deviation; CI, confidence 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%)

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 confidence intervals. No reported deaths were associated with device deficiency.

Abbreviation: CI, confidence interval.

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%)
Average FiO2	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 H2O)	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, confidence interval; CPAP, continuous positive airway pressure; SIMV, synchronized intermittent mandatory ventilation; SPONT, spontaneous breathing mode; FiO₂, 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 SpO2 (%)	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 PaCO2 (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
Average PaO2 (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 HCO3 (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, confidence interval; SpO₂, oxygen saturation; PaCO₂, partial pressure of carbon dioxide; PaO₂, partial pressure of oxygen; HCO₃, bicarbonate.