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

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:

MedlinePlus related topics: Obesity Sleep Apnea Weight Control Weight Loss Surgery

U.S. FDA Resources

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:	October 2013
Estimated Primary Completion Date:	August 2013 (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

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:

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. Epub 2010 Jan 6.

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.

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.

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. Erratum in: JAMA 2002 Oct 23-30;288(16):1985.

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.

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.

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.

Loadsman JA, Hillman DR. Anaesthesia and sleep apnoea. Br J Anaesth. 2001 Feb;86(2):254-66. Review.

Hillman DR, Loadsman JA, Platt PR, Eastwood PR. Obstructive sleep apnoea and anaesthesia. Sleep Med Rev. 2004 Dec;8(6):459-71. Review.

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.

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. Epub 2009 Apr 29.

White DP. Opioid-induced suppression of genioglossal muscle activity: is it clinically important? J Physiol. 2009 Jul 15;587(Pt 14):3421-2.

Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Coté 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. No abstract available.

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:	April 22, 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 May 22, 2013