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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01697878
First received: September 21, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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 Intervention
Obstructive Sleep Apnea
Obesity
Procedure: CPAP followed by atmospheric pressure
Procedure: Atmospheric pressure followed by CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Consequences of Obstructive Sleep Apnea on Respiratory Function Following Weight-loss Surgery: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • apnea hypopnea index (AHI) [ Time Frame: preoperatively for one night of sleep and during 2 hours of recovery room stay ] [ Designated as safety issue: Yes ]
    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:
  • apneas after opioid bolus self-administration [ Time Frame: 5 minutes after each opioid PCA administration ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 130
Study Start Date: March 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697878

Contacts
Contact: Matthias Eikermann, MD-PhD 617-643-4408 meikermann@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Matthias Eikermann, MD-PhD    617-643-4408    meikermann@partners.org   
Contact: Britta Brueckmann, MD    617-643-7735    bbrueckmann@partners.org   
Principal Investigator: Matthias Eikermann, MD-PhD         
Sub-Investigator: Hooman Mirzakhani, MD         
Sponsors and Collaborators
Massachusetts General Hospital
ResMed
Investigators
Principal Investigator: Matthias Eikermann, MD-PhD Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Matthias Eikermann, Assistant Pofessor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01697878     History of Changes
Other Study ID Numbers: 2011P001333, ResMed
Study First Received: September 21, 2012
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
obstructive sleep apnea
obesity
respiratory function
weight loss surgery

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

ClinicalTrials.gov processed this record on July 22, 2014