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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01697878
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : March 17, 2016
Information provided by (Responsible Party):
Matthias Eikermann, 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).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Obesity Procedure: CPAP followed by atmospheric pressure Procedure: Atmospheric pressure followed by CPAP Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Consequences of Obstructive Sleep Apnea on Respiratory Function Following Weight-loss Surgery: A Randomized Controlled Trial
Study Start Date : March 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Randomization Group 1
CPAP first followed by standard of care
Procedure: CPAP followed by atmospheric pressure
In the PACU, Patients receive 2 hours of continuous-positive-airway-pressure (CPAP) oxygen at 30% FiO2 treatment followed by 2 hours of oxygen treatment (6 L O2/min) that is part of standard of care at Massachusetts General Hospital
Other Name: Tx Plan 1

Active Comparator: Randomization group 2
Standard of care followed by CPAP
Procedure: Atmospheric pressure followed by CPAP
In the PACU, patients receive 2 hours of Oxygen treatment (6L/min) that is part of standard-of-care at Massachusetts General Hospital, followed by 2 hours of Continuous Positive Airway Pressure (CPAP) treatment at 30% FiO2.
Other Name: Tx Plan 2

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. apneas after opioid bolus self-administration [ Time Frame: 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01697878

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Matthias Eikermann, MD-PhD Massachusetts General Hospital


Responsible Party: Matthias Eikermann, Assistant Pofessor, Massachusetts General Hospital Identifier: NCT01697878     History of Changes
Other Study ID Numbers: 2011P001333
ResMed ( Other Grant/Funding Number: 2011D001139 )
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016

Keywords provided by Matthias Eikermann, Massachusetts General Hospital:
obstructive sleep apnea
respiratory function
weight loss surgery

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Weight Loss
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Body Weight Changes
Body Weight