search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP followed by atmospheric pressure
Atmospheric pressure followed by CPAP
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, obesity, respiratory function, weight loss surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Randomization Group 1

Randomization group 2

Arm Description

CPAP first followed by standard of care

Standard of care followed by CPAP

Outcomes

Primary Outcome Measures

apnea hypopnea index (AHI)
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
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

Full Information

First Posted
September 21, 2012
Last Updated
March 16, 2016
Sponsor
Massachusetts General Hospital
Collaborators
ResMed
search

1. Study Identification

Unique Protocol Identification Number
NCT01697878
Brief Title
Consequences of Obstructive Sleep Apnea on Respiratory Function Following Weight-loss Surgery
Official Title
Consequences of Obstructive Sleep Apnea on Respiratory Function Following Weight-loss Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
ResMed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Obesity
Keywords
obstructive sleep apnea, obesity, respiratory function, weight loss surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomization Group 1
Arm Type
Experimental
Arm Description
CPAP first followed by standard of care
Arm Title
Randomization group 2
Arm Type
Active Comparator
Arm Description
Standard of care followed by CPAP
Intervention Type
Procedure
Intervention Name(s)
CPAP followed by atmospheric pressure
Other Intervention Name(s)
Tx Plan 1
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Atmospheric pressure followed by CPAP
Other Intervention Name(s)
Tx Plan 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
apnea hypopnea index (AHI)
Description
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.
Time Frame
preoperatively for one night of sleep and during 2 hours of recovery room stay
Secondary Outcome Measure Information:
Title
apneas after opioid bolus self-administration
Description
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
Time Frame
5 minutes after each opioid PCA administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Eikermann, MD-PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20052560
Citation
Malbois M, Giusti V, Suter M, Pellaton C, Vodoz JF, Heinzer R. Oximetry alone versus portable polygraphy for sleep apnea screening before bariatric surgery. Obes Surg. 2010 Mar;20(3):326-31. doi: 10.1007/s11695-009-0055-9. Epub 2010 Jan 6.
Results Reference
background
PubMed Identifier
19641201
Citation
Longitudinal Assessment of Bariatric Surgery (LABS) Consortium; Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W, Pories W, Courcoulas A, McCloskey C, Mitchell J, Patterson E, Pomp A, Staten MA, Yanovski SZ, Thirlby R, Wolfe B. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009 Jul 30;361(5):445-54. doi: 10.1056/NEJMoa0901836.
Results Reference
background
PubMed Identifier
10805822
Citation
Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.
Results Reference
background
PubMed Identifier
10770144
Citation
Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829. Erratum In: JAMA 2002 Oct 23-30;288(16):1985.
Results Reference
background
PubMed Identifier
11179104
Citation
Faccenda JF, Mackay TW, Boon NA, Douglas NJ. Randomized placebo-controlled trial of continuous positive airway pressure on blood pressure in the sleep apnea-hypopnea syndrome. Am J Respir Crit Care Med. 2001 Feb;163(2):344-8. doi: 10.1164/ajrccm.163.2.2005037.
Results Reference
background
PubMed Identifier
16282178
Citation
Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.
Results Reference
background
PubMed Identifier
14746392
Citation
Meoli AL, Rosen CL, Kristo D, Kohrman M, Gooneratne N, Aguillard RN, Fayle R, Troell R, Kramer R, Casey KR, Coleman J Jr; Clinical Practice Review Committee; American Academy of Sleep Medicine. Upper airway management of the adult patient with obstructive sleep apnea in the perioperative period--avoiding complications. Sleep. 2003 Dec 15;26(8):1060-5. doi: 10.1093/sleep/26.8.1060.
Results Reference
background
PubMed Identifier
11573670
Citation
Loadsman JA, Hillman DR. Anaesthesia and sleep apnoea. Br J Anaesth. 2001 Feb;86(2):254-66. doi: 10.1093/bja/86.2.254.
Results Reference
background
PubMed Identifier
15556378
Citation
Hillman DR, Loadsman JA, Platt PR, Eastwood PR. Obstructive sleep apnoea and anaesthesia. Sleep Med Rev. 2004 Dec;8(6):459-71. doi: 10.1016/j.smrv.2004.07.002.
Results Reference
background
PubMed Identifier
8665050
Citation
Mezzanotte WS, Tangel DJ, White DP. Influence of sleep onset on upper-airway muscle activity in apnea patients versus normal controls. Am J Respir Crit Care Med. 1996 Jun;153(6 Pt 1):1880-7. doi: 10.1164/ajrccm.153.6.8665050.
Results Reference
background
PubMed Identifier
19403616
Citation
Hajiha M, DuBord MA, Liu H, Horner RL. Opioid receptor mechanisms at the hypoglossal motor pool and effects on tongue muscle activity in vivo. J Physiol. 2009 Jun 1;587(Pt 11):2677-92. doi: 10.1113/jphysiol.2009.171678. Epub 2009 Apr 29.
Results Reference
background
PubMed Identifier
19602634
Citation
White DP. Opioid-induced suppression of genioglossal muscle activity: is it clinically important? J Physiol. 2009 Jul 15;587(Pt 14):3421-2. doi: 10.1113/jphysiol.2009.176388. No abstract available.
Results Reference
background
PubMed Identifier
16645462
Citation
Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Cote CJ, Nickinovich DG, Prachand V, Ward DS, Weaver EM, Ydens L, Yu S; American Society of Anesthesiologists Task Force on Perioperative Management. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2006 May;104(5):1081-93; quiz 1117-8. doi: 10.1097/00000542-200605000-00026. No abstract available.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs