<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01697878</url>
  </required_header>
  <id_info>
    <org_study_id>2011P001333</org_study_id>
    <secondary_id>ResMed</secondary_id>
    <nct_id>NCT01697878</nct_id>
  </id_info>
  <brief_title>Consequences of Obstructive Sleep Apnea on Respiratory Function Following Weight-loss Surgery</brief_title>
  <official_title>Consequences of Obstructive Sleep Apnea on Respiratory Function Following Weight-loss Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ResMed</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to compare two different treatments, continuous positive airway&#xD;
      pressure (CPAP) versus breathing of atmospheric pressure, in subjects with obstructive sleep&#xD;
      apnea (OSA)recovering from weight loss surgery in the post anesthesia care unit (PACU). WE&#xD;
      hypothesize that subjects with OSA will have a higher Apnea-Hypopnea Index (AHI) with&#xD;
      desaturation and the investigators expect that post-operative CPAP treatment in the PACU will&#xD;
      significantly improve the AHI and therefore improve patient safety in the PACU. The&#xD;
      investigators also hypothesize that subjects with OSA have a greater decrease in oxygen&#xD;
      saturation in response to opioid administration by patient-controlled opioid analgesia (PCA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with morbid obesity have an approximately 60-80 percent incidence of OSA depending&#xD;
      on the criteria used for making diagnosis, and they are suggested to be at increased risk to&#xD;
      develop serious perioperative complications, especially during the postoperative period.&#xD;
      Weight loss might be considered as an appropriate treatment of OSA but in turn it has&#xD;
      recently been reported that OSA is an independent risk factor for development of&#xD;
      perioperative complications, importantly oxygen desaturation, in patients undergoing weight&#xD;
      loss surgery. It seems logical to evaluate if these patients would benefit from&#xD;
      post-operative CPAP treatment in the PACU. The results of this multidisciplinary study will&#xD;
      have an impact on PACU treatment of patients with OSA and will further optimize patient care&#xD;
      at MGH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>apnea hypopnea index (AHI)</measure>
    <time_frame>preoperatively for one night of sleep and during 2 hours of recovery room stay</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>apneas after opioid bolus self-administration</measure>
    <time_frame>5 minutes after each opioid PCA administration</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Randomization Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CPAP first followed by standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Randomization group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care followed by CPAP</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CPAP followed by atmospheric pressure</intervention_name>
    <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</description>
    <arm_group_label>Randomization Group 1</arm_group_label>
    <other_name>Tx Plan 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Atmospheric pressure followed by CPAP</intervention_name>
    <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.</description>
    <arm_group_label>Randomization group 2</arm_group_label>
    <other_name>Tx Plan 2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled for weight loss surgery at Massachusetts General Hospital&#xD;
&#xD;
          -  Male and female subjects&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CNS disease with impairment of cognitive function and/or muscle paresis such as&#xD;
             stroke, or dementia&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  missing or insufficient PSG data to make diagnosis OSA&#xD;
&#xD;
          -  impaired decision making capacity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Eikermann, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>20052560</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19641201</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>10805822</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>10770144</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11179104</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16282178</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>14746392</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11573670</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>15556378</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>8665050</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19403616</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19602634</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16645462</PMID>
  </reference>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>March 16, 2016</last_update_submitted>
  <last_update_submitted_qc>March 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Matthias Eikermann</investigator_full_name>
    <investigator_title>Assistant Pofessor</investigator_title>
  </responsible_party>
  <keyword>obstructive sleep apnea</keyword>
  <keyword>obesity</keyword>
  <keyword>respiratory function</keyword>
  <keyword>weight loss surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01697878
org study id: 2011P001333
secondary id: ResMed
nct id: NCT01697878
lead sponsor: 
collaborator: 
has dmc: No
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).
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: apnea hypopnea index (AHI)
time frame: preoperatively for one night of sleep and during 2 hours of recovery room stay
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.
measure: apneas after opioid bolus self-administration
time frame: 5 minutes after each opioid PCA 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
arm group label: Randomization Group 1
arm group type: Experimental
description: CPAP first followed by standard of care
arm group label: Randomization group 2
arm group type: Active Comparator
description: Standard of care followed by CPAP
intervention type: Procedure
intervention name: CPAP followed by atmospheric pressure
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
arm group label: Randomization Group 1
other name: Tx Plan 1
intervention type: Procedure
intervention name: Atmospheric pressure followed by CPAP
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.
arm group label: Randomization group 2
other name: Tx Plan 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthias Eikermann, MD-PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
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.
PMID: 20052560
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.
PMID: 19641201
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.
PMID: 10805822
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.
PMID: 10770144
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.
PMID: 11179104
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.
PMID: 16282178
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.
PMID: 14746392
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.
PMID: 11573670
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.
PMID: 15556378
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.
PMID: 8665050
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.
PMID: 19403616
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.
PMID: 19602634
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.
PMID: 16645462
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Matthias Eikermann
investigator title: Assistant Pofessor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Weight Loss