- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02209220
Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA Patients Awaiting Bariatric Surgery (APAP-CPAP)
1 de agosto de 2019 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
50
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Quebec
-
Quebec City, Quebec, Canadá, G1V 4G5
- Institut universitaire de Cardiologie et de Pneumologie de Quebec
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Automatic positive airway pressure
Automatic positive airway pressure treatment of obstructive sleep apnea
|
Outros nomes:
|
|
Comparador Ativo: Continuous positive airway pressure
Continuous positive airway pressure for the treatment of obstructive sleep apnea
|
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Compliance of APAP and CPAP
Prazo: at time of surgery
|
Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
|
at time of surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean pressure level with APAP and CPAP
Prazo: 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
Prazo: 1 month
|
Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.
|
1 month
|
|
Residual apnea + hypopnea index
Prazo: 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
Prazo: 1 month
|
Number of residual respiratory events recorded by the positive pressure device during the treatment period
|
1 month
|
|
epworth sleepiness score
Prazo: at time of surgery
|
Somnolence measured by Epworth Sleepiness Scale;
|
at time of surgery
|
|
quality of life score with APAP and CPAP
Prazo: 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
Prazo: at time of surgery
|
Positive airway pressure adverse effects measured by a visual analogic scale.
|
at time of surgery
|
|
Compliance of APAP and CPAP
Prazo: 1 month
|
Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
|
1 month
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Frédéric Séries, MD, Laval University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2014
Conclusão Primária (Real)
16 de março de 2018
Conclusão do estudo (Real)
16 de março de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
25 de junho de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de agosto de 2014
Primeira postagem (Estimativa)
5 de agosto de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de agosto de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de agosto de 2019
Última verificação
1 de agosto de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- APAP-21014
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .