Trial Outcomes & Findings for Oxygen Saturation Monitoring During Surgery (NCT NCT01098851)

NCT ID: NCT01098851

Last Updated: 2014-08-07

Results Overview

Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.

• Recruitment status: COMPLETED
• Target enrollment: 21 participants
• Primary outcome timeframe: 3 hours
• Results posted on: 2014-08-07

Participant Flow

Patients were recruited from July through November 2009 in the medical clinic who were scheduled for surgery that required procedural sedation.

Participant milestones

Measure	Obstructive Sleep Apnea Surgery patients at high risk for Obstructive Sleep Apnea	Surgery Patients Surgery patients at low risk for Obstructive Sleep Apnea
Overall Study STARTED	11	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Obstructive Sleep Apnea Surgery patients at high risk for Obstructive Sleep Apnea	Surgery Patients Surgery patients at low risk for Obstructive Sleep Apnea
Overall Study Equipment failure	1	0

Baseline Characteristics

Oxygen Saturation Monitoring During Surgery

Baseline characteristics by cohort

Measure	Obstructive Sleep Apnea n=11 Participants Surgery patients at high risk for Obstructive Sleep Apnea	Surgery Patients n=10 Participants Surgery patients at low risk for Obstructive Sleep Apnea	Total n=21 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	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 10 • n=5 Participants	36 years STANDARD_DEVIATION 7 • n=7 Participants	48 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 hours

Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.

Outcome measures

Measure	Obstructive Sleep Apnea n=11 Participants Surgery patients at high risk for Obstructive Sleep Apnea	Surgery Patients n=10 Participants Surgery patients at low risk for Obstructive Sleep Apnea
Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow	4 Participants	0 Participants

PRIMARY outcome

Timeframe: 3 hours

Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure.

Outcome measures

Measure	Obstructive Sleep Apnea n=11 Participants Surgery patients at high risk for Obstructive Sleep Apnea	Surgery Patients n=10 Participants Surgery patients at low risk for Obstructive Sleep Apnea
Number of Participants Requiring Airway Support	8 Participants	4 Participants

Adverse Events

Obstructive Sleep Apnea

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Surgery Patients

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

Fran Haury

Covidien

Phone: 303 305-2314

Email: fran.haury@covidien.com

Results disclosure agreements

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

Restriction type: LTE60