CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
CPAP followed by atmospheric pressure +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01697878
NCT01697878N/ACompleted

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

Massachusetts General Hospital·interventional·Posted Oct 2, 2012·Updated Mar 17, 2016

In Brief

A clinical study evaluating CPAP followed by atmospheric pressure and Atmospheric pressure followed by CPAP for Obstructive Sleep Apnea and Obesity. Completed, enrolled 45 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsResMed

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2012
Enrollment StartMar 1, 2012
Primary CompletionJul 1, 2014
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.8 years ago

Interventions

CPAP followed by atmospheric pressureprocedure

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

Atmospheric pressure followed by CPAPprocedure

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.