Evaluation of Sleep Apnea and Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia
NCT ID: NCT02833662
Last Updated: 2016-07-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-06-30
Study Completion Date
2017-07-31
Brief Summary
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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.
Aggravation of nocturnal respiratory disorder and higher incidence of cardiac and respiratory postoperative complications will be assessed in OSA patients.
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Detailed Description
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Conditions
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Obstructive Sleep Apnea
Arrhythmia
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
SCREENING
Blinding Strategy
NONE
Study Groups
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Patients suspected to present a Sleep Apnea Syndrom
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.
Group Type
OTHER
Measure of ODI and heart rhythm
Intervention Type
OTHER
Record nocturnal respiratory and cardiac parameters before and after surgery.
Interventions
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Measure of ODI and heart rhythm
Record nocturnal respiratory and cardiac parameters before and after surgery.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* orthopaedic, urologic, vascular, digestive surgery
* under general anaesthesia or sedation
* age \> 45 years old
* STOP-BANG score\>3
* 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
* Severe COPD
* Post-operative ICU planned
* Diagnosed OSA or other sleep disorder breathing
Minimum Eligible Age
45 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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AGIR à Dom
OTHER
Sponsor Role
collaborator
University Hospital, Grenoble
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Renaud TAMISIER, Md,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Seguin L, Mendelson M, Doutreleau S, Clin R, Destors M, Albaladejo P, Pepin JL, Payen JF, Tamisier R. Temporal link between cardiac arrhythmias and postoperative episodes of hypoxemia during nocturnal sleep in patients with obstructive sleep apnea syndrome. Sleep Med. 2024 Dec;124:260-267. doi: 10.1016/j.sleep.2024.09.014. Epub 2024 Sep 12.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
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38RC15.080
Identifier Type: -
Identifier Source: org_study_id
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