Trial Outcomes & Findings for CPAP vs AutoCPAP for Treatment of Obstructive Sleep Apnea (OSA) in the Postoperative Setting (NCT NCT00588848)

NCT ID: NCT00588848

Last Updated: 2019-01-14

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
• Results posted on: 2019-01-14

Participant Flow

Only 11 subjects were recruited but only 8 successfully completed the study (3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep). This resulted in early termination of the study.

No significant events to report.

Participant milestones

Measure	AUTOCPAP An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night) Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery).	CPAP Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night) Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)
Overall Study STARTED	3	8
Overall Study COMPLETED	3	5
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	AUTOCPAP An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night) Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery).	CPAP Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night) Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)
Overall Study Physician Decision	0	3

Baseline Characteristics

CPAP vs AutoCPAP for Treatment of Obstructive Sleep Apnea (OSA) in the Postoperative Setting

Baseline characteristics by cohort

Measure	AUTOCPAP n=3 Participants An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night) Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery).	CPAP n=8 Participants Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night) Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50.3 years STANDARD_DEVIATION 9.0 • n=5 Participants	52.5 years STANDARD_DEVIATION 7.5 • n=7 Participants	51.2 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	8 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.

Population: 3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep.

Outcome measures

Measure	AUTOCPAP n=3 Participants An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night) Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery).	CPAP n=5 Participants Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night) Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)
Sleep Related Hypoxemia	10.5 Percentage of time < 90% saturation Interval 0.0 to 52.0	7.1 Percentage of time < 90% saturation Interval 0.0 to 30.1

SECONDARY outcome

Timeframe: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.

Population: 3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep. Study was terminated early due to enrollment problems.

Events are defined as apneas and hypopneas. AHI values are typically categorized as 5-14.9 events/hr = mild; 15-29.9 events/hr = moderate; and >= 30 events/hr = severe

Outcome measures

Measure	AUTOCPAP n=3 Participants An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night) Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery).	CPAP n=5 Participants Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night) Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)
Apnea-Hypopnea Index (AHI)	2.1 events per hour Interval 0.0 to 5.5	1.2 events per hour Interval 0.0 to 3.5

SECONDARY outcome

Timeframe: 72 hours

Population: None in either group

Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke

Outcome measures

Measure	AUTOCPAP n=3 Participants An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night) Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery).	CPAP n=5 Participants Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night) Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)
Cardiopulmonary Complications	0 Participants	0 Participants

Adverse Events

AUTOCPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dennis Auckley

MetroHealth Medical Center

Phone: 216-778-7212

Email: dauckley@metrohealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place