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

Mass General Brigham

Status: Completed

Conditions: Obesity; Obstructive Sleep Apnea

Treatments: Procedure: CPAP followed by atmospheric pressure; Procedure: Atmospheric pressure followed by CPAP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01697878

ResMed (Other Grant/Funding Number)

2011P001333

Details and patient eligibility

About

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).

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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45 participants in 2 patient groups

Randomization Group 1

Experimental group

Description:

CPAP first followed by standard of care

Treatment:

Procedure: CPAP followed by atmospheric pressure

Randomization group 2

Active Comparator group

Description:

Standard of care followed by CPAP

Treatment:

Procedure: Atmospheric pressure followed by CPAP