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Evaluation of Sleep Apnea and Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia (Etude3A)

Primary Purpose

Obstructive Sleep Apnea, Arrhythmia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Measure of ODI and heart rhythm
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Obstructive Sleep Apnea focused on measuring Hypoxia, Perioperative outcomes

Eligibility Criteria

45 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • orthopaedic, urologic, vascular, digestive surgery
  • under general anaesthesia or sedation
  • age > 45 years old
  • STOP-BANG score>3

Exclusion Criteria:

  • Head and neck surgery, planned prolonged mechanical ventilation after surgery (>24h)
  • Severe COPD
  • Post-operative ICU planned
  • Diagnosed OSA or other sleep disorder breathing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Patients suspected to present a Sleep Apnea Syndrom

    Arm Description

    Record nocturnal respiratory and cardiac parameters before and after surgery : Severity of sleep respiratory disorders and relationship with cardiac rhythm abnormalities will be assessed in patients suspected to present Sleep Apnea, before and after surgery under general anesthesia.

    Outcomes

    Primary Outcome Measures

    Change from baseline in heart rhythm troubles linked to hypoxemia events
    Heart rhythm troubles will be assessed 3 times: First time = baseline assessment, during one night before surgery second assessment will occur during the first night after surgery last assessment will take place during the third night after surgery

    Secondary Outcome Measures

    Change from baseline in severity of OSA defined by the oxygen saturation index
    OSA will be assessed 3 times: First time = baseline assessment, during one night before surgery second assessment will occur during the first night after surgery last assessment will take place during the third night after surgery oxygen saturation index > 10 mandatory for the study oxygen saturation index > 40 : result qualified severe
    Aggravation of cardiac events linked to hypoxemia
    Change from baseline OSA prevalence and cardiorespiratory complications after surgery

    Full Information

    First Posted
    June 3, 2015
    Last Updated
    July 12, 2016
    Sponsor
    University Hospital, Grenoble
    Collaborators
    AGIR à Dom
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02833662
    Brief Title
    Evaluation of Sleep Apnea and Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia
    Acronym
    Etude3A
    Official Title
    Evolution of the Severity of Obstructive Sleep Apnea and Consequences on Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Grenoble
    Collaborators
    AGIR à Dom

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Higher risk of cardiac and respiratory post-operative events is observed in patients with unrecognised Obstructive Sleep Apnea (OSA). The efficiency of a simple method of OSA screening by analysing ventilation with measurement of nose pressure and nocturnal hypoxemia (oxygen desaturation index) will be assessed. These sleep respiratory analyses will be compared with the research of arrhythmia, in order to show if they are linked to the hypoxemia events. Aggravation of nocturnal respiratory disorder and higher incidence of cardiac and respiratory postoperative complications will be assessed in OSA patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea, Arrhythmia
    Keywords
    Hypoxia, Perioperative outcomes

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients suspected to present a Sleep Apnea Syndrom
    Arm Type
    Other
    Arm Description
    Record nocturnal respiratory and cardiac parameters before and after surgery : Severity of sleep respiratory disorders and relationship with cardiac rhythm abnormalities will be assessed in patients suspected to present Sleep Apnea, before and after surgery under general anesthesia.
    Intervention Type
    Other
    Intervention Name(s)
    Measure of ODI and heart rhythm
    Intervention Description
    Record nocturnal respiratory and cardiac parameters before and after surgery.
    Primary Outcome Measure Information:
    Title
    Change from baseline in heart rhythm troubles linked to hypoxemia events
    Description
    Heart rhythm troubles will be assessed 3 times: First time = baseline assessment, during one night before surgery second assessment will occur during the first night after surgery last assessment will take place during the third night after surgery
    Time Frame
    Before surgery and at first and third night after surgery
    Secondary Outcome Measure Information:
    Title
    Change from baseline in severity of OSA defined by the oxygen saturation index
    Description
    OSA will be assessed 3 times: First time = baseline assessment, during one night before surgery second assessment will occur during the first night after surgery last assessment will take place during the third night after surgery oxygen saturation index > 10 mandatory for the study oxygen saturation index > 40 : result qualified severe
    Time Frame
    Before surgery and at first and third night after surgery
    Title
    Aggravation of cardiac events linked to hypoxemia
    Time Frame
    After surgery from night 1 to night 15 maximum
    Title
    Change from baseline OSA prevalence and cardiorespiratory complications after surgery
    Time Frame
    Before surgery and at first and third night after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: orthopaedic, urologic, vascular, digestive surgery under general anaesthesia or sedation age > 45 years old STOP-BANG score>3 Exclusion Criteria: Head and neck surgery, planned prolonged mechanical ventilation after surgery (>24h) Severe COPD Post-operative ICU planned Diagnosed OSA or other sleep disorder breathing
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Renaud TAMISIER, Md,PhD
    Organizational Affiliation
    University Hospital, Grenoble
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24158049
    Citation
    Chung F, Liao P, Yegneswaran B, Shapiro CM, Kang W. Postoperative changes in sleep-disordered breathing and sleep architecture in patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):287-98. doi: 10.1097/ALN.0000000000000040.
    Results Reference
    background
    PubMed Identifier
    22956642
    Citation
    Kaw R, Chung F, Pasupuleti V, Mehta J, Gay PC, Hernandez AV. Meta-analysis of the association between obstructive sleep apnoea and postoperative outcome. Br J Anaesth. 2012 Dec;109(6):897-906. doi: 10.1093/bja/aes308. Epub 2012 Sep 6.
    Results Reference
    background
    PubMed Identifier
    25000252
    Citation
    Vizzardi E, Sciatti E, Bonadei I, D'Aloia A, Curnis A, Metra M. Obstructive sleep apnoea-hypopnoea and arrhythmias: new updates. J Cardiovasc Med (Hagerstown). 2017 Jul;18(7):490-500. doi: 10.2459/JCM.0000000000000043.
    Results Reference
    background
    PubMed Identifier
    22671991
    Citation
    Kilicaslan F, Tokatli A, Ozdag F, Uzun M, Uz O, Isilak Z, Yiginer O, Yalcin M, Guney MS, Cebeci BS. Tp-e interval, Tp-e/QT ratio, and Tp-e/QTc ratio are prolonged in patients with moderate and severe obstructive sleep apnea. Pacing Clin Electrophysiol. 2012 Aug;35(8):966-72. doi: 10.1111/j.1540-8159.2012.03439.x. Epub 2012 Jun 5.
    Results Reference
    background
    PubMed Identifier
    24158050
    Citation
    Chung F, Liao P, Elsaid H, Shapiro CM, Kang W. Factors associated with postoperative exacerbation of sleep-disordered breathing. Anesthesiology. 2014 Feb;120(2):299-311. doi: 10.1097/ALN.0000000000000041.
    Results Reference
    background
    PubMed Identifier
    23257990
    Citation
    Singh M, Liao P, Kobah S, Wijeysundera DN, Shapiro C, Chung F. Proportion of surgical patients with undiagnosed obstructive sleep apnoea. Br J Anaesth. 2013 Apr;110(4):629-36. doi: 10.1093/bja/aes465. Epub 2012 Dec 19.
    Results Reference
    background
    PubMed Identifier
    7842763
    Citation
    Rennotte MT, Baele P, Aubert G, Rodenstein DO. Nasal continuous positive airway pressure in the perioperative management of patients with obstructive sleep apnea submitted to surgery. Chest. 1995 Feb;107(2):367-74. doi: 10.1378/chest.107.2.367.
    Results Reference
    background
    PubMed Identifier
    23533751
    Citation
    Latina JM, Estes NA 3rd, Garlitski AC. The Relationship between Obstructive Sleep Apnea and Atrial Fibrillation: A Complex Interplay. Pulm Med. 2013;2013:621736. doi: 10.1155/2013/621736. Epub 2013 Feb 26.
    Results Reference
    background
    PubMed Identifier
    23243398
    Citation
    Gupta S, Cepeda-Valery B, Romero-Corral A, Shamsuzzaman A, Somers VK, Pressman GS. Association between QRS duration and obstructive sleep apnea. J Clin Sleep Med. 2012 Dec 15;8(6):649-54. doi: 10.5664/jcsm.2256.
    Results Reference
    background
    PubMed Identifier
    23691306
    Citation
    Filgueiras-Rama D, Arias MA, Iniesta A, Armada E, Merino JL, Peinado R, Lopez-Sendon JL. Atrial arrhythmias in obstructive sleep apnea: underlying mechanisms and implications in the clinical setting. Pulm Med. 2013;2013:426758. doi: 10.1155/2013/426758. Epub 2013 Apr 3.
    Results Reference
    background
    PubMed Identifier
    23258782
    Citation
    Rossi VA, Stradling JR, Kohler M. Effects of obstructive sleep apnoea on heart rhythm. Eur Respir J. 2013 Jun;41(6):1439-51. doi: 10.1183/09031936.00128412. Epub 2012 Dec 20.
    Results Reference
    background
    PubMed Identifier
    23770166
    Citation
    Gami AS, Olson EJ, Shen WK, Wright RS, Ballman KV, Hodge DO, Herges RM, Howard DE, Somers VK. Obstructive sleep apnea and the risk of sudden cardiac death: a longitudinal study of 10,701 adults. J Am Coll Cardiol. 2013 Aug 13;62(7):610-6. doi: 10.1016/j.jacc.2013.04.080. Epub 2013 Jun 13.
    Results Reference
    background
    PubMed Identifier
    18431116
    Citation
    Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
    Results Reference
    background
    PubMed Identifier
    22401881
    Citation
    Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8.
    Results Reference
    background
    PubMed Identifier
    22805548
    Citation
    Chouchou F, Poupard L, Philippe C, Court-Fortune I, Barthelemy JC, Roche F. Thoracic impedance, in association with oximetry, in a multi-modal ECG Holter system is useful for screening sleep disordered breathing. Int J Cardiol. 2013 Feb 10;163(1):100-2. doi: 10.1016/j.ijcard.2012.06.082. Epub 2012 Jul 16. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21789729
    Citation
    Poupard L, Mathieu M, Goldman M, Chouchou F, Roche F. Multi-modal ECG Holter system for sleep-disordered breathing screening: a validation study. Sleep Breath. 2012 Sep;16(3):685-93. doi: 10.1007/s11325-011-0558-1. Epub 2011 Jul 26.
    Results Reference
    background
    PubMed Identifier
    18398330
    Citation
    Baguet JP, Levy P, Barone-Rochette G, Tamisier R, Pierre H, Peeters M, Mallion JM, Pepin JL. Masked hypertension in obstructive sleep apnea syndrome. J Hypertens. 2008 May;26(5):885-92. doi: 10.1097/HJH.0b013e3282f55049.
    Results Reference
    background
    PubMed Identifier
    19028140
    Citation
    Pepin JL, Defaye P, Vincent E, Christophle-Boulard S, Tamisier R, Levy P. Sleep apnea diagnosis using an ECG Holter device including a nasal pressure (NP) recording: validation of visual and automatic analysis of nasal pressure versus full polysomnography. Sleep Med. 2009 Jun;10(6):651-6. doi: 10.1016/j.sleep.2008.07.002. Epub 2008 Nov 22.
    Results Reference
    background
    PubMed Identifier
    19228987
    Citation
    Tamisier R, Gilmartin GS, Launois SH, Pepin JL, Nespoulet H, Thomas R, Levy P, Weiss JW. A new model of chronic intermittent hypoxia in humans: effect on ventilation, sleep, and blood pressure. J Appl Physiol (1985). 2009 Jul;107(1):17-24. doi: 10.1152/japplphysiol.91165.2008. Epub 2009 Feb 19.
    Results Reference
    background
    PubMed Identifier
    20522795
    Citation
    Pepin JL, Tamisier R, Barone-Rochette G, Launois SH, Levy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.
    Results Reference
    background
    PubMed Identifier
    20525723
    Citation
    Tamisier R, Pepin JL, Remy J, Baguet JP, Taylor JA, Weiss JW, Levy P. 14 nights of intermittent hypoxia elevate daytime blood pressure and sympathetic activity in healthy humans. Eur Respir J. 2011 Jan;37(1):119-28. doi: 10.1183/09031936.00204209. Epub 2010 Jun 4.
    Results Reference
    background
    PubMed Identifier
    22523363
    Citation
    Roche F, Pepin JL, Achour-Crawford E, Tamisier R, Pichot V, Celle S, Maudoux D, Chouchou F, Ntougou-Assoumou HG, Levy P, Barthelemy JC; PROOF Study Group. At 68 years, unrecognised sleep apnoea is associated with elevated ambulatory blood pressure. Eur Respir J. 2012 Sep;40(3):649-56. doi: 10.1183/09031936.00162710. Epub 2012 Apr 20.
    Results Reference
    background
    PubMed Identifier
    23471270
    Citation
    Cereda CW, Tamisier R, Manconi M, Andreotti J, Frangi J, Pifferini V, Bassetti CL. Endothelial dysfunction and arterial stiffness in ischemic stroke: the role of sleep-disordered breathing. Stroke. 2013 Apr;44(4):1175-8. doi: 10.1161/STROKEAHA.111.000112. Epub 2013 Mar 7.
    Results Reference
    background
    PubMed Identifier
    23409736
    Citation
    Gasa M, Tamisier R, Launois SH, Sapene M, Martin F, Stach B, Grillet Y, Levy P, Pepin JL; Scientific Council of the Sleep Registry of the French Federation of Pneumology-FFP. Residual sleepiness in sleep apnea patients treated by continuous positive airway pressure. J Sleep Res. 2013 Aug;22(4):389-97. doi: 10.1111/jsr.12039. Epub 2013 Feb 15.
    Results Reference
    background
    PubMed Identifier
    24768555
    Citation
    Maziere S, Pepin JL, Siyanko N, Bioteau C, Launois S, Tamisier R, Arnol N, Levy P, Couturier P, Bosson JL, Gavazzi G. Usefulness of oximetry for sleep apnea screening in frail hospitalized elderly. J Am Med Dir Assoc. 2014 Jun;15(6):447.e9-14. doi: 10.1016/j.jamda.2014.03.011. Epub 2014 Apr 24.
    Results Reference
    background
    PubMed Identifier
    24264333
    Citation
    Minville C, Hilleret MN, Tamisier R, Aron-Wisnewsky J, Clement K, Trocme C, Borel JC, Levy P, Zarski JP, Pepin JL. Nonalcoholic fatty liver disease, nocturnal hypoxia, and endothelial function in patients with sleep apnea. Chest. 2014 Mar 1;145(3):525-533. doi: 10.1378/chest.13-0938.
    Results Reference
    background
    PubMed Identifier
    32925319
    Citation
    Seguin L, Tamisier R, Deletombe B, Lopez M, Pepin JL, Payen JF. Preoperative Screening for Obstructive Sleep Apnea Using Alternative Scoring Models of the Sleep Tiredness Observed Pressure-Body Mass Index Age Neck Circumference Gender Questionnaire: An External Validation. Anesth Analg. 2020 Oct;131(4):1025-1031. doi: 10.1213/ANE.0000000000004909.
    Results Reference
    derived

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    Evaluation of Sleep Apnea and Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia

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