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Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA Patients Awaiting Bariatric Surgery (APAP-CPAP)
1 août 2019 mis à jour par: Frédéric Sériès, Laval University
Impact of Automatic Positive Airway Pressure on Treatment Compliance in Obstructive Sleep Apnea Patients Awaiting Bariatric Surgery
Obstructive sleep apnea (OSA) is a syndrome characterized by intermittent dynamic obstruction of the upper airways that causes a fall in oxygen saturation, reflex sympathetic activation and sleep micro-arousals.
In surgical patients, OSA is a well-known risk factor for perioperative complications.
At Institut Universitaire de cardiologie et de Pneumologie de Quebec (IUCPQ), the investigators perform more than 450 bariatric surgeries per year.
Consequently, the identification and management of OSA in this high-risk surgical population is an essential part of practice.
Actual guidelines recommend that treatment for OSA be initiated before the surgical procedure.
Presently, the first line treatment for OSA is continuous positive airway pressure (CPAP) therapy delivering a fixed pressure continuously to maintain the patency of the upper airways.
However the compliance to this therapy is poor.
An available alternative is automatic positive airway pressure (APAP) which delivers a variable amount of pressure to prevent reduction in airflow that accompanies upper airway obstruction.
The APAP delivers the lowest pressure needed to prevent upper airways collapse.
APAP significantly reduces the mean level of pressure delivered in comparison to conventional treatment.
Theoretically, it seems logical that applying the lowest pressure necessary would allow a better device-patient synchrony and therefore improve patient's comfort.Recent trials comparing APAP and CPAP have shown that APAP is non-inferior to CPAP in controlling obstructive events.
APAP would be a valuable alternative if it was not for its excess cost.
However, APAP improves compliance to treatment in two types of population: poor compliant subjects and those needing high pressure levels.
The investigators know that compliance to positive pressure is poor in patients without excessive daytime sleepiness, which represents the majority of patient waiting bariatric surgery.
Moreover, in patients needing levels of pressure ≥ 10 water cm (cmH20), APAP improves treatment compliance, minimises side effects and improves quality of life.
The review of 180 files of OSA patients treated by CPAP who had bariatric surgery in our center in 2012 demonstrated that the majority of patients needed high level pressure.
These values suggest that APAP could improve treatment compliance in apneic patients waiting for bariatric surgery because they are usually poorly symptomatic and they generally require high positive pressure level.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Quebec
-
Quebec City, Quebec, Canada, G1V 4G5
- Institut Universitaire de cardiologie et de pneumologie de Quebec
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Obese patients with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with additional risk factors for cardiovascular disease and eligible for bariatric surgery;
- Laparoscopic bariatric surgery planned in 2-6 months. Procedures include biliopancreatic diversion with duodenal switch and sleeve gastrectomy;
- Recent diagnosis of obstructive sleep apnea made by a sleep study. The sleep study must be a overnight pulse oximetry showing a 3% desaturation index ≥ 25/hour or a polysomnography with a apnea + hypopnea index (AHI) ≥ 25/hour* ;
- No previous use of positive airway pressure device;
- ≥18 year old.
Exclusion Criteria:
- Severe comorbidities (respiratory, cardiac, neurologic or metabolic unstable disease);
- Central sleep apnea;
- Obesity hypoventilation syndrome;
- Planned bariatric surgery by laparotomy;
- Contraindications to positive airway pressure therapy: pneumothorax within the preceding 6 months, cerebrospinal fluid leak, cranial surgery or trauma within the last year.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Automatic positive airway pressure
Automatic positive airway pressure treatment of obstructive sleep apnea
|
Autres noms:
|
|
Comparateur actif: Continuous positive airway pressure
Continuous positive airway pressure for the treatment of obstructive sleep apnea
|
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Compliance of APAP and CPAP
Délai: at time of surgery
|
Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
|
at time of surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean pressure level with APAP and CPAP
Délai: at time of surgery
|
Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.
|
at time of surgery
|
|
Mean pressure level with APAP and CPAP
Délai: 1 month
|
Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.
|
1 month
|
|
Residual apnea + hypopnea index
Délai: at time of surgery
|
Number of residual respiratory events recorded by the positive pressure device during the treatment period
|
at time of surgery
|
|
Residual apnea + hypopnea index
Délai: 1 month
|
Number of residual respiratory events recorded by the positive pressure device during the treatment period
|
1 month
|
|
epworth sleepiness score
Délai: at time of surgery
|
Somnolence measured by Epworth Sleepiness Scale;
|
at time of surgery
|
|
quality of life score with APAP and CPAP
Délai: at time of surgery
|
Quality of life measured by Questionnaire sur la Qualité de vie du Québec
|
at time of surgery
|
|
Positive pressure therapy adverse events
Délai: at time of surgery
|
Positive airway pressure adverse effects measured by a visual analogic scale.
|
at time of surgery
|
|
Compliance of APAP and CPAP
Délai: 1 month
|
Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
|
1 month
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Frédéric Séries, MD, Laval University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- 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.
- 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.
- Kuna ST, Reboussin DM, Borradaile KE, Sanders MH, Millman RP, Zammit G, Newman AB, Wadden TA, Jakicic JM, Wing RR, Pi-Sunyer FX, Foster GD; Sleep AHEAD Research Group of the Look AHEAD Research Group. Long-term effect of weight loss on obstructive sleep apnea severity in obese patients with type 2 diabetes. Sleep. 2013 May 1;36(5):641-649A. doi: 10.5665/sleep.2618.
- Smith I, Lasserson TJ. Pressure modification for improving usage of continuous positive airway pressure machines in adults with obstructive sleep apnoea. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD003531. doi: 10.1002/14651858.CD003531.pub3.
- Parish JM, Miller BW, Hentz JG. Autotitration positive airway pressure therapy in patients with obstructive sleep apnea who are intolerant of fixed continuous positive airway pressure. Sleep Breath. 2008 Aug;12(3):235-41. doi: 10.1007/s11325-007-0158-2. Epub 2007 Nov 28.
- Wolkove N, Baltzan M, Kamel H, Dabrusin R, Palayew M. Long-term compliance with continuous positive airway pressure in patients with obstructive sleep apnea. Can Respir J. 2008 Oct;15(7):365-9. doi: 10.1155/2008/534372.
- Massie CA, McArdle N, Hart RW, Schmidt-Nowara WW, Lankford A, Hudgel DW, Gordon N, Douglas NJ. Comparison between automatic and fixed positive airway pressure therapy in the home. Am J Respir Crit Care Med. 2003 Jan 1;167(1):20-3. doi: 10.1164/rccm.200201-022OC. Epub 2002 Oct 4.
- Lacasse Y, Bureau MP, Series F. A new standardised and self-administered quality of life questionnaire specific to obstructive sleep apnoea. Thorax. 2004 Jun;59(6):494-9. doi: 10.1136/thx.2003.011205.
- Kermelly SB, Lajoie AC, Boucher ME, Series F. Impact of continuous positive airway pressure mode on adherence to treatment in obstructive sleep apnea patients awaiting bariatric surgery. J Sleep Res. 2021 Oct;30(5):e13288. doi: 10.1111/jsr.13288. Epub 2021 Feb 6.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2014
Achèvement primaire (Réel)
16 mars 2018
Achèvement de l'étude (Réel)
16 mars 2018
Dates d'inscription aux études
Première soumission
25 juin 2014
Première soumission répondant aux critères de contrôle qualité
1 août 2014
Première publication (Estimation)
5 août 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 août 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 août 2019
Dernière vérification
1 août 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- APAP-21014
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .