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

Obstructive Sleep Apnea Clinical Trial

— Etude3A  

Official title:

Evolution of the Severity of Obstructive Sleep Apnea and Consequences on Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02833662
• Other study ID #: 38RC15.080
• Status: Active, not recruiting
• Phase: N/A
• First received: June 3, 2015
• Last updated: July 12, 2016
• Start date: June 2015
• Est. completion date: July 2017

Study information

• Verified date: May 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 99 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Apnea
• Arrhythmia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Measure of ODI and heart rhythm
Record nocturnal respiratory and cardiac parameters before and after surgery.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	AGIR à Dom

References & Publications (26)

Baguet JP, Lévy P, Barone-Rochette G, Tamisier R, Pierre H, Peeters M, Mallion JM, Pépin JL. Masked hypertension in obstructive sleep apnea syndrome. J Hypertens. 2008 May;26(5):885-92. doi: 10.1097/HJH.0b013e3282f55049. — View 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. — View Citation

Chouchou F, Poupard L, Philippe C, Court-Fortune I, Barthélémy 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Filgueiras-Rama D, Arias MA, Iniesta A, Armada E, Merino JL, Peinado R, López-Sendón 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Mazière S, Pépin JL, Siyanko N, Bioteau C, Launois S, Tamisier R, Arnol N, Lévy 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. — View Citation

Minville C, Hilleret MN, Tamisier R, Aron-Wisnewsky J, Clement K, Trocme C, Borel JC, Lévy P, Zarski JP, Pépin JL. Nonalcoholic fatty liver disease, nocturnal hypoxia, and endothelial function in patients with sleep apnea. Chest. 2014 Mar 1;145(3):525-33. doi: 10.1378/chest.13-0938. — View Citation

Pépin JL, Defaye P, Vincent E, Christophle-Boulard S, Tamisier R, Lévy 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. — View Citation

Pépin JL, Tamisier R, Barone-Rochette G, Launois SH, Lévy 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. — View 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. — View 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. — View Citation

Roche F, Pépin JL, Achour-Crawford E, Tamisier R, Pichot V, Celle S, Maudoux D, Chouchou F, Ntougou-Assoumou HG, Lévy P, Barthélémy 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. Epub 2012 Apr 20. — View 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. Review. — View 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. — View Citation

Tamisier R, Gilmartin GS, Launois SH, Pépin JL, Nespoulet H, Thomas R, Lévy 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. — View Citation

Tamisier R, Pépin JL, Rémy J, Baguet JP, Taylor JA, Weiss JW, Lévy 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. — View 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). 2014 Jul 3. [Epub ahead of print] — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Before surgery and at first and third night after surgery	No
Secondary	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	Before surgery and at first and third night after surgery	No
Secondary	Aggravation of cardiac events linked to hypoxemia		After surgery from night 1 to night 15 maximum	No
Secondary	Change from baseline OSA prevalence and cardiorespiratory complications after surgery		Before surgery and at first and third night after surgery	No