Completed

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

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What is being tested

CPAP followed by atmospheric pressure

+ Atmospheric pressure followed by CPAP

Procedure
Who is being recruted

Apnea+16

+ Body Weight

+ Nervous System Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: March 2012
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: March 17, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01697878
Principal SponsorMassachusetts General Hospital
Last updated: March 17, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaBody WeightNervous System DiseasesNutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesRespiration DisordersRespiratory Tract DiseasesSigns and SymptomsSleep Apnea SyndromesSleep Wake DisordersPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasOvernutritionOverweightObesitySleep Apnea, ObstructiveRespiratory Aspiration

Criteria

3 inclusion criteria required to participate
Male and female subjects
age >= 18 years
patients scheduled for weight loss surgery at Massachusetts General Hospital
4 exclusion criteria prevent from participating
CNS disease with impairment of cognitive function and/or muscle paresis such as stroke, or dementia
age < 18 years
impaired decision making capacity
missing or insufficient PSG data to make diagnosis OSA

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
CPAP first followed by standard of care

Group II

Active Comparator
Standard of care followed by CPAP

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
CompletedOne Study Center