Consequences of Obstructive Sleep Apnea on Respiratory Function Following Weight-loss Surgery

Not Applicable

Completed

• Conditions: Obesity; Obstructive Sleep Apnea
• Interventions: Procedure: CPAP followed by atmospheric pressure; Procedure: Atmospheric pressure followed by CPAP

• Registration Number: NCT01697878
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The investigators propose to compare two different treatments, continuous positive airway pressure (CPAP) versus breathing of atmospheric pressure, in subjects with obstructive sleep apnea (OSA)recovering from weight loss surgery in the post anesthesia care unit (PACU). WE hypothesize that subjects with OSA will have a higher Apnea-Hypopnea Index (AHI) with desaturation and the investigators expect that post-operative CPAP treatment in the PACU will significantly improve the AHI and therefore improve patient safety in the PACU. The investigators also hypothesize that subjects with OSA have a greater decrease in oxygen saturation in response to opioid administration by patient-controlled opioid analgesia (PCA).

Detailed Description

Patients with morbid obesity have an approximately 60-80 percent incidence of OSA depending on the criteria used for making diagnosis, and they are suggested to be at increased risk to develop serious perioperative complications, especially during the postoperative period. Weight loss might be considered as an appropriate treatment of OSA but in turn it has recently been reported that OSA is an independent risk factor for development of perioperative complications, importantly oxygen desaturation, in patients undergoing weight loss surgery. It seems logical to evaluate if these patients would benefit from post-operative CPAP treatment in the PACU. The results of this multidisciplinary study will have an impact on PACU treatment of patients with OSA and will further optimize patient care at MGH.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-10-02
• Primary Completion: 2014-07
• Status Verified: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• patients scheduled for weight loss surgery at Massachusetts General Hospital
• Male and female subjects
• age ≥ 18 years

Exclusion Criteria

• CNS disease with impairment of cognitive function and/or muscle paresis such as stroke, or dementia
• age < 18 years
• missing or insufficient PSG data to make diagnosis OSA
• impaired decision making capacity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Randomization Group 1	CPAP followed by atmospheric pressure	CPAP first followed by standard of care
Randomization group 2	Atmospheric pressure followed by CPAP	Standard of care followed by CPAP

Primary Outcome Measures

Name	Time	Method
apnea hypopnea index (AHI)	preoperatively for one night of sleep and during 2 hours of recovery room stay	The AHI is assessed for one night's sleep in the initial at-home sleep study conducted with a portable Alice monitor. Subsequently, the AHI is assessed during the patient's stay in the post-anesthesia-care unit (PACU) during which time they receive CPAP and oxygen treatment.

Secondary Outcome Measures

Name	Time	Method
apneas after opioid bolus self-administration	5 minutes after each opioid PCA administration	We are assessing the effects of OSA on apneas occurring in a 5 minute time-frame after opioid bolus self administration in the PACU, and consider these as related to opioid administration

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States