Trial Outcomes & Findings for FiO2 Closed Loop Control Ventilation (NCT NCT02810080)

Last Updated: 2024-08-15

Results Overview

Relative duration is (time within SpO2 target of 92-96%)/12 hours where higher value demonstrates better ability of FiO2 control method to maintain appropriate oxygen saturation. Relative time the patient's SpO2 was maintained within target over the 12 hours on the study device, calculated as total time each patient had SpO2 within the 92 - 96% range divided by 12 hours with arcsin square root transformation

Recruitment status

COMPLETED

Target enrollment

210 participants

Primary outcome timeframe

12 hours

Results posted on

2024-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	Closed Loop Control Ventilation automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Closed Loop Control Ventilation: Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software	Manual Control Ventilation manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator
Overall Study STARTED	104	102
Overall Study COMPLETED	97	98
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Closed Loop Control Ventilation automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Closed Loop Control Ventilation: Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software	Manual Control Ventilation manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator
Overall Study Adverse Event	3	0
Overall Study Death	0	2
Overall Study Physician Decision	4	0
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

FiO2 Closed Loop Control Ventilation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Closed Loop Control Ventilation n=104 Participants automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Closed Loop Control Ventilation: Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software	Manual Control Ventilation n=102 Participants manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator	Total n=206 Participants Total of all reporting groups
Age, Continuous	37.2 years STANDARD_DEVIATION 13.07 • n=5 Participants	39.6 years STANDARD_DEVIATION 14.19 • n=7 Participants	38.4 years STANDARD_DEVIATION 13.66 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	79 Participants n=7 Participants	161 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	86 Participants n=7 Participants	174 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) White	65 Participants n=5 Participants	67 Participants n=7 Participants	132 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	104 Participants n=5 Participants	102 Participants n=7 Participants	206 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours

Outcome measures

Outcome measures
Measure	Closed Loop Control Ventilation n=104 Participants automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Closed Loop Control Ventilation: Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software	Manual Control Ventilation n=102 Participants manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator
Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours]	0.53 arbitrary units Standard Deviation 0.37	0.61 arbitrary units Standard Deviation 0.36

PRIMARY outcome

Timeframe: 24 hours after intervention

Number of participants with SpO2 less than 88% at anytime while on study device

Outcome measures

Outcome measures
Measure	Closed Loop Control Ventilation n=104 Participants automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Closed Loop Control Ventilation: Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software	Manual Control Ventilation n=102 Participants manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator
Number of Participants With SpO2 Less Than 88% at Anytime While on Study Device	31 Participants	49 Participants

SECONDARY outcome

Timeframe: 12 hours

Relative duration is (time within SpO2 target of either a) 92-96% when FiO2 is greater than 21% or b) greater than or equal to 92% when FiO2 equals 21%)/12 hours where higher value demonstrates better ability of FiO2 control method to maintain appropriate oxygen saturation. Relative time the patient's SpO2 was maintained within target over the 12 hours on the study device, calculated as total time each patient had SpO2 within the range divided by 12 hours with arcsin square root transformation

Outcome measures

Outcome measures
Measure	Closed Loop Control Ventilation n=104 Participants automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Closed Loop Control Ventilation: Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software	Manual Control Ventilation n=102 Participants manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator
Relative Duration of Time With SpO2 92 to 96% When FiO2 is Greater Than 21% and SpO2 is Greater Than or Equal to 92% When Fi02 "Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours]	0.92 arbitrary units Standard Deviation 0.34	0.83 arbitrary units Standard Deviation 0.36

Adverse Events

Closed Loop Control Ventilation

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Manual Control Ventilation

Serious events: 9 serious events

Other events: 17 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Closed Loop Control Ventilation n=104 participants at risk automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Closed Loop Control Ventilation: Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software	Manual Control Ventilation n=102 participants at risk manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome (ARDS)	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Cardiac disorders Atrial fibrillation with rapid ventricular response	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Nervous system disorders Cerebral Edema	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Vascular disorders Hypotension	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Nervous system disorders Intracerbral hemorrhage	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
General disorders Multi organ failure	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Cardiac disorders Pericardial Tamponade	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Vascular disorders Subarachnoid hemorrhage	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.

Other adverse events

Additional Information

Nathan Burkhart

ZOLL

Phone: 763.367.0462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Closed Loop Control Ventilation n=104 participants at risk automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Closed Loop Control Ventilation: Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software	Manual Control Ventilation n=102 participants at risk manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator
General disorders Agitation	1.9% 2/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Cardiac disorders Atrial fibrillation	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Infections and infestations Bacteremia	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Infections and infestations Clostridium Difficle Infection	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Gastrointestinal disorders Coffee ground emesis	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Respiratory, thoracic and mediastinal disorders Device removal failed	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Infections and infestations Fever	2.9% 3/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	3.9% 4/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Gastrointestinal disorders gastric dilation	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Metabolism and nutrition disorders Hyperkalemia	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Respiratory, thoracic and mediastinal disorders Hyperoxemia	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Metabolism and nutrition disorders Hypophosphatemia	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Vascular disorders Hypotension	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Vascular disorders Hypovolemia	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Respiratory, thoracic and mediastinal disorders Hypoxemia	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Respiratory, thoracic and mediastinal disorders hypoxia	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	2.0% 2/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Immune system disorders Leukocytosis	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Nervous system disorders Mental status change	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Metabolism and nutrition disorders Metabolic Acidosis	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Nervous system disorders Neurological examination abnormal	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Infections and infestations Pneumonia	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Cardiac disorders Premature ventricular contractions	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Renal and urinary disorders Renal replacement therapy	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Cardiac disorders Sinus tachycardia	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Eye disorders Swelling of eyelid	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Cardiac disorders Troponin increase	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Renal and urinary disorders Urinary retention	0.00% 0/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.98% 1/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
Nervous system disorders VIIth nerve paralysis	0.96% 1/104 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.	0.00% 0/102 • From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.