- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02796846
Association of CPAP Compliance Study
Association of CPAP Compliance and Nocturnal Hypoxemia in the Perioperative Period
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Obstruktiv søvnapnø (OSA) er en almindelig søvnrelateret vejrtrækningsforstyrrelse. CPAP er etableret for at være den første linje behandling for OSA-patienter med forbedring af livskvalitet og betydelig reduktion i forekomsten af kardiovaskulære hændelser. Der mangler dog stort set evidens for CPAP's effektivitet i den perioperative periode. En prospektiv kohorteundersøgelse udført af Brar et al. fandt, at på trods af brugen af ordineret CPAP-terapi blev 18 % af OSA-patienter hypoksiske natten efter operationen, og de gik ind for postoperativ oximetrimonitorering hos CPAP-behandlede OSA-kirurgiske patienter.
Efterforskerne vil gerne bestemme effekten af CPAP-compliance med hensyn til at reducere postoperativ hypoxi og andre komplikationer hos kirurgiske patienter med OSA. Resultaterne fra denne undersøgelse ville give værdifulde data om frekvensen af manglende overholdelse af CPAP hos de kirurgiske patienter med en historie med diagnosticeret OSA og en CPAP-recept og virkningen af manglende overholdelse af CPAP på postoperative resultater, især iltmætning.
I denne undersøgelse vil alle diagnosticerede OSA-kirurgiske patienter med eller uden en CPAP-recept blive kontaktet for informeret samtykke til at tilmelde sig undersøgelsen. Alle undersøgelsesdeltagere vil blive overvåget for O2-desaturation ved at bruge et armbåndsurs pulsoximeter derhjemme i en nat præoperativt og de første 3 nætter postoperativt på hospitalet.
De tilmeldte forsøgspersoner medbringer deres egne CPAP-enheder (certificeret af hospitalets ingeniørafdeling i henhold til hospitalets politik) og maske til hospitalet. OSA-patienter uden en CPAP-recept vil blive fulgt op perioperativt for at bestemme sværhedsgraden af deres OSA og for at fastslå begrundelsen for ingen CPAP-recept.
Præ- og postoperative CPAP-brugsdata vil blive indsamlet gennem interview af patienten, kortgennemgang og overvågning af registrering i den smarte CPAP-enhed.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Alle voksne kirurgiske patienter (>18 år) med diagnosen OSA med eller uden CPAP-recept.
Planlagt til en ikke-hjertekirurgi (almen kirurgi, ortopædi, urologi, plastikkirurgi og rygsøjle), der forventes at kræve et postoperativt hospitalsophold på mere end én nat.
Beskrivelse
Inklusionskriterier:
- Alle voksne kirurgiske patienter (>18 år) med diagnosen OSA med eller uden CPAP-recept.
- Planlagt til en ikke-hjertekirurgi (almen kirurgi, ortopædi, urologi, plastikkirurgi og rygsøjle), der forventes at kræve et postoperativt hospitalsophold på mere end én nat.
Ekskluderingskriterier:
- De er uvillige eller ude af stand til at give informeret samtykke til undersøgelsen.
- De får supplerende ilt præoperativt (dag eller nat).
- De er gravide.
- Kirurgi inkluderet tonsillektomi, septoplastik, uvuloplastik, pharyngoplasty, tracheostomi eller forlænget (> 48 timer) postoperativ mekanisk ventilation af lungerne forventes. Disse procedurer/interventioner vil sandsynligvis helbrede eller i det mindste ændre sværhedsgraden af OSA.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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CPAP-receptgruppe
Patienter med en CPAP-recept (både kompatibel og ikke-kompatibel)
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Uden CPAP-recept
Patienter uden en CPAP-recept for at opfylde vores primære mål/målsætninger.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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CPAP-overholdelse
Tidsramme: (gennemsnitlig CPAP-brug ≥ 4 timer/nat).
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CPAP-overholdelse (gennemsnitlig CPAP-brug ≥ 4 timer/nat)
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(gennemsnitlig CPAP-brug ≥ 4 timer/nat).
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Chung F, Liao P, Elsaid H, Islam S, Shapiro CM, Sun Y. Oxygen desaturation index from nocturnal oximetry: a sensitive and specific tool to detect sleep-disordered breathing in surgical patients. Anesth Analg. 2012 May;114(5):993-1000. doi: 10.1213/ANE.0b013e318248f4f5. Epub 2012 Feb 24.
- Squadrone V, Coha M, Cerutti E, Schellino MM, Biolino P, Occella P, Belloni G, Vilianis G, Fiore G, Cavallo F, Ranieri VM; Piedmont Intensive Care Units Network (PICUN). Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial. JAMA. 2005 Feb 2;293(5):589-95. doi: 10.1001/jama.293.5.589.
- 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.
- Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
- Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
- Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
- Galatius-Jensen S, Hansen J, Rasmussen V, Bildsoe J, Therboe M, Rosenberg J. Nocturnal hypoxaemia after myocardial infarction: association with nocturnal myocardial ischaemia and arrhythmias. Br Heart J. 1994 Jul;72(1):23-30. doi: 10.1136/hrt.72.1.23.
- 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.
- Gami AS, Pressman G, Caples SM, Kanagala R, Gard JJ, Davison DE, Malouf JF, Ammash NM, Friedman PA, Somers VK. Association of atrial fibrillation and obstructive sleep apnea. Circulation. 2004 Jul 27;110(4):364-7. doi: 10.1161/01.CIR.0000136587.68725.8E. Epub 2004 Jul 12.
- Kanagala R, Murali NS, Friedman PA, Ammash NM, Gersh BJ, Ballman KV, Shamsuzzaman AS, Somers VK. Obstructive sleep apnea and the recurrence of atrial fibrillation. Circulation. 2003 May 27;107(20):2589-94. doi: 10.1161/01.CIR.0000068337.25994.21. Epub 2003 May 12.
- 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.
- Catley DM, Thornton C, Jordan C, Lehane JR, Royston D, Jones JG. Pronounced, episodic oxygen desaturation in the postoperative period: its association with ventilatory pattern and analgesic regimen. Anesthesiology. 1985 Jul;63(1):20-8. doi: 10.1097/00000542-198507000-00004.
- Esclamado RM, Glenn MG, McCulloch TM, Cummings CW. Perioperative complications and risk factors in the surgical treatment of obstructive sleep apnea syndrome. Laryngoscope. 1989 Nov;99(11):1125-9. doi: 10.1288/00005537-198911000-00004.
- Kaw R, Pasupuleti V, Walker E, Ramaswamy A, Foldvary-Schafer N. Postoperative complications in patients with obstructive sleep apnea. Chest. 2012 Feb;141(2):436-441. doi: 10.1378/chest.11-0283. Epub 2011 Aug 25.
- Hwang D, Shakir N, Limann B, Sison C, Kalra S, Shulman L, Souza Ade C, Greenberg H. Association of sleep-disordered breathing with postoperative complications. Chest. 2008 May;133(5):1128-34. doi: 10.1378/chest.07-1488. Epub 2008 Mar 13.
- Liao P, Yegneswaran B, Vairavanathan S, Zilberman P, Chung F. Postoperative complications in patients with obstructive sleep apnea: a retrospective matched cohort study. Can J Anaesth. 2009 Nov;56(11):819-28. doi: 10.1007/s12630-009-9190-y.
- Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG.
- Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.
- Kribbs NB, Pack AI, Kline LR, Smith PL, Schwartz AR, Schubert NM, Redline S, Henry JN, Getsy JE, Dinges DF. Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. Am Rev Respir Dis. 1993 Apr;147(4):887-95. doi: 10.1164/ajrccm/147.4.887.
- Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.
- Chung F, Elsaid H. Screening for obstructive sleep apnea before surgery: why is it important? Curr Opin Anaesthesiol. 2009 Jun;22(3):405-11. doi: 10.1097/ACO.0b013e32832a96e2.
- Gupta RM, Parvizi J, Hanssen AD, Gay PC. Postoperative complications in patients with obstructive sleep apnea syndrome undergoing hip or knee replacement: a case-control study. Mayo Clin Proc. 2001 Sep;76(9):897-905. doi: 10.4065/76.9.897.
- Chung F, Ward B, Ho J, Yuan H, Kayumov L, Shapiro C. Preoperative identification of sleep apnea risk in elective surgical patients, using the Berlin questionnaire. J Clin Anesth. 2007 Mar;19(2):130-4. doi: 10.1016/j.jclinane.2006.08.006.
- Keamy MF 3rd, Cadieux RJ, Kofke WA, Kales A. The occurrence of obstructive sleep apnea in a recovery room patient. Anesthesiology. 1987 Feb;66(2):232-4. doi: 10.1097/00000542-198702000-00023. No abstract available.
- Lamarche Y, Martin R, Reiher J, Blaise G. The sleep apnoea syndrome and epidural morphine. Can Anaesth Soc J. 1986 Mar;33(2):231-3. doi: 10.1007/BF03010837.
- Nishino T, Shirahata M, Yonezawa T, Honda Y. Comparison of changes in the hypoglossal and the phrenic nerve activity in response to increasing depth of anesthesia in cats. Anesthesiology. 1984 Jan;60(1):19-24. doi: 10.1097/00000542-198401000-00005.
- Sollevi A, Lindahl SG. Hypoxic and hypercapnic ventilatory responses during isoflurane sedation and anaesthesia in women. Acta Anaesthesiol Scand. 1995 Oct;39(7):931-8. doi: 10.1111/j.1399-6576.1995.tb04200.x.
- 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.
- Memtsoudis S, Liu SS, Ma Y, Chiu YL, Walz JM, Gaber-Baylis LK, Mazumdar M. Perioperative pulmonary outcomes in patients with sleep apnea after noncardiac surgery. Anesth Analg. 2011 Jan;112(1):113-21. doi: 10.1213/ANE.0b013e3182009abf. Epub 2010 Nov 16.
- Mokhlesi B. Empiric postoperative autotitrating positive airway pressure therapy: generating evidence in the perioperative care of patients at risk for obstructive sleep apnea. Chest. 2013 Jul;144(1):5-7. doi: 10.1378/chest.13-0017. No abstract available.
- Gilmartin GS, Tamisier R, Curley M, Weiss JW. Ventilatory, hemodynamic, sympathetic nervous system, and vascular reactivity changes after recurrent nocturnal sustained hypoxia in humans. Am J Physiol Heart Circ Physiol. 2008 Aug;295(2):H778-85. doi: 10.1152/ajpheart.00653.2007. Epub 2008 Jun 6.
- Fletcher EC. Hypertension in patients with sleep apnoea, a combined effect? Thorax. 2000 Sep;55(9):726-8. doi: 10.1136/thorax.55.9.726. No abstract available.
- Rosenberg J, Ullstad T, Rasmussen J, Hjorne FP, Poulsen NJ, Goldman MD. Time course of postoperative hypoxaemia. Eur J Surg. 1994 Mar;160(3):137-43.
- Kehlet H, Rosenberg J. Late post-operative hypoxaemia and organ dysfunction. Eur J Anaesthesiol Suppl. 1995 May;10:31-4.
- Lam B, Sam K, Mok WY, Cheung MT, Fong DY, Lam JC, Lam DC, Yam LY, Ip MS. Randomised study of three non-surgical treatments in mild to moderate obstructive sleep apnoea. Thorax. 2007 Apr;62(4):354-9. doi: 10.1136/thx.2006.063644. Epub 2006 Nov 22.
- Weingarten TN, Flores AS, McKenzie JA, Nguyen LT, Robinson WB, Kinney TM, Siems BT, Wenzel PJ, Sarr MG, Marienau MS, Schroeder DR, Olson EJ, Morgenthaler TI, Warner DO, Sprung J. Obstructive sleep apnoea and perioperative complications in bariatric patients. Br J Anaesth. 2011 Jan;106(1):131-9. doi: 10.1093/bja/aeq290. Epub 2010 Oct 18.
- Liao P, Luo Q, Elsaid H, Kang W, Shapiro CM, Chung F. Perioperative auto-titrated continuous positive airway pressure treatment in surgical patients with obstructive sleep apnea: a randomized controlled trial. Anesthesiology. 2013 Oct;119(4):837-47. doi: 10.1097/ALN.0b013e318297d89a. Erratum In: Anesthesiology. 2014 May;120(5):1302. Anesthesiology. 2014 May;120(5):1302.
- Kohler M, Smith D, Tippett V, Stradling JR. Predictors of long-term compliance with continuous positive airway pressure. Thorax. 2010 Sep;65(9):829-32. doi: 10.1136/thx.2010.135848.
- Mehta V, Subramanyam R, Shapiro CM, Chung F. Health effects of identifying patients with undiagnosed obstructive sleep apnea in the preoperative clinic: a follow-up study. Can J Anaesth. 2012 Jun;59(6):544-55. doi: 10.1007/s12630-012-9694-8. Epub 2012 Mar 30.
- Reeves-Hoche MK, Meck R, Zwillich CW. Nasal CPAP: an objective evaluation of patient compliance. Am J Respir Crit Care Med. 1994 Jan;149(1):149-54. doi: 10.1164/ajrccm.149.1.8111574.
- O'Gorman SM, Gay PC, Morgenthaler TI. Does autotitrating positive airway pressure therapy improve postoperative outcome in patients at risk for obstructive sleep apnea syndrome? A randomized controlled clinical trial. Chest. 2013 Jul;144(1):72-78. doi: 10.1378/chest.12-0989.
- Guralnick AS, Pant M, Minhaj M, Sweitzer BJ, Mokhlesi B. CPAP adherence in patients with newly diagnosed obstructive sleep apnea prior to elective surgery. J Clin Sleep Med. 2012 Oct 15;8(5):501-6. doi: 10.5664/jcsm.2140.
- Richard W, Kox D, den Herder C, Laman M, van Tinteren H, de Vries N. The role of sleep position in obstructive sleep apnea syndrome. Eur Arch Otorhinolaryngol. 2006 Oct;263(10):946-50. doi: 10.1007/s00405-006-0090-2. Epub 2006 Jun 27.
- Charbonneau M, Marin JM, Olha A, Kimoff RJ, Levy RD, Cosio MG. Changes in obstructive sleep apnea characteristics through the night. Chest. 1994 Dec;106(6):1695-701. doi: 10.1378/chest.106.6.1695.
- Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. Validation of the Berlin questionnaire and American Society of Anesthesiologists checklist as screening tools for obstructive sleep apnea in surgical patients. Anesthesiology. 2008 May;108(5):822-30. doi: 10.1097/ALN.0b013e31816d91b5.
- Chung F, Yegneswaran B, Herrera F, Shenderey A, Shapiro CM. Patients with difficult intubation may need referral to sleep clinics. Anesth Analg. 2008 Sep;107(3):915-20. doi: 10.1213/ane.0b013e31817bd36f.
- Chung F, Liao P, Sun Y, Amirshahi B, Fazel H, Shapiro CM, Elsaid H. Perioperative practical experiences in using a level 2 portable polysomnography. Sleep Breath. 2011 Sep;15(3):367-75. doi: 10.1007/s11325-010-0340-9. Epub 2010 Mar 16.
- Ramakant Sharma ISB. CPAP for Obstructive Sleep Apnea in the Post-Operative Setting: An Oximetry Evaluation Study. J Sleep Disord Ther 2013;02.
- Suen C, Wong J, Warsame K, Subramani Y, Panzarella T, Waseem R, Auckley D, Chaudhry R, Islam S, Chung F. Perioperative adherence to continuous positive airway pressure and its effect on postoperative nocturnal hypoxemia in obstructive sleep apnea patients: a prospective cohort study. BMC Anesthesiol. 2021 May 11;21(1):142. doi: 10.1186/s12871-021-01371-0.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Version date: October 6, 2017
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Kliniske forsøg med Obstruktiv søvnapnø
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University of Wisconsin, MadisonPhilips HealthcareAfsluttetSøvn, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
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Aventure ABAktiv, ikke rekrutterende
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National Taiwan University HospitalUkendt
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National University of SingaporeRekrutteringReduktion af skærmbrug + Sleep Extension | Frit levendeSingapore
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The First Affiliated Hospital of Shanxi Medical...Shanxi Medical UniversityAfsluttetSøvnkvalitet | Søvnvarighed | Sleep Onset LatencyKina
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Northwell HealthJazz PharmaceuticalsRekrutteringElektrisk status Epilepticus af Slow-Wave SleepForenede Stater
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University of Geneva, SwitzerlandAfsluttetNatlige benkramper | Sleep Wake Transition DisordersSchweiz
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Tyco Healthcare GroupUkendt
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Maastricht University Medical CenterEpilepsiecentrum KempenhaegheAfsluttetRolandsk Epilepsi | Landau-Kleffners syndrom | Natlig frontallappens epilepsi | Elektrisk status Epilepticus under Slow Wave SleepHolland