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Clinical Trials/NCT01697878
NCT01697878
Completed
Not Applicable

Consequences of Obstructive Sleep Apnea on Respiratory Function Following Weight-loss Surgery: A Randomized Controlled Trial

Massachusetts General Hospital1 site in 1 country45 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Massachusetts General Hospital
Enrollment
45
Locations
1
Primary Endpoint
apnea hypopnea index (AHI)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
March 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthias Eikermann

Assistant Pofessor

Massachusetts General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

apnea hypopnea index (AHI)

Time Frame: 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 Outcomes

  • apneas after opioid bolus self-administration(5 minutes after each opioid PCA administration)

Study Sites (1)

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