Interfaces of Non-invasive Ventilation on Performance in Patients With Chronic Obstructive Pulmonary Disease (Exercise-NIV)
8 de janeiro de 2019 atualizado por: ADIR Association
Impact of Various Interfaces of Non-invasive Ventilation on Performance During Exercise in Patients With Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine wether the interface (facial or nasal mask) influences performance in patients with chronic obstructive pulmonary disease exercising with non-invasive ventilation.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
21
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
-
-
-
Bois-Guillaume, França
- ADIR Association
-
-
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:
- Age > 18 years
- Chronic obstructive pulmonary disease Gold III-IV
- Eligible for pulmonary rehabilitation
- Exercise limitation : at least respiratory limitation (ventilatory reserve ≤ 30%)
Non-inclusion Criteria:
- Pregnant woman or likely to be
- Familiar with home non-invasive ventilation
- Patient under guardianship
Exclusion Criteria:
- Acute exacerbation of chronic obstructive pulmonary disease
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 cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: CWLT with facial mask
This study has a cross-over design.
Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order.
|
Every patients will achieve 3 constant work load test (CWLT) at 75% Wpic.
The first CWLT will be realized without any ventilatory support.
The 2 others CWLT will be achieved with non-invasive ventilation support using facial or nasal interface in a randomized order.
|
|
Experimental: CWLT with nasal mask
This study has a cross-over design.
Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order.
|
Every patients will achieve 3 constant work load test (CWLT) at 75% Wpic.
The first CWLT will be realized without any ventilatory support.
The 2 others CWLT will be achieved with non-invasive ventilation support using facial or nasal interface in a randomized order.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Endurance time (Tlim, in second) during Constant Work Load Test (CWLT).
Prazo: The outcome will be measure after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Patients will achieve 3 Constant Work Load Test Under different conditions (1 without noninvasive ventilation and 2 with noninvasive ventilation using in a randomised order facial or nasal mask).
Endurance time (sec) will be recorded at the end of every test.
|
The outcome will be measure after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Comfort of different masks using numerical scale (0-10) after exercising with noninvasive ventilation.
Prazo: The outcome will be measure after every CWLT achieved with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
The comfort of the different interfaces is assessed after every CWLT using numerical scale.
|
The outcome will be measure after every CWLT achieved with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
|
Dyspnea during CWLT using modified Borg Scale (0-10).
Prazo: The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.
|
The dyspnea will be assessed every 30sec during CWLT.
Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.
|
|
Exhaustion during CWLT using modified Borg Scale (0-10).
Prazo: The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.
|
The exhaustion will be assessed every 30sec during CWLT.
Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.
|
|
Heart rate (rpm) during CWLT using capnograph.
Prazo: The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
|
Blood pressure (mmHg) before and after every CWLT using electrical blood pressure device.
Prazo: The outcome will be assessed before and after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
The outcome will be assessed before and after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
|
|
Oxygen saturation (SpO2, %) during CWLT using capnograph.
Prazo: The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
|
Transcutaneous carbon dioxide pressure (PtcCO2, mmHg) during CWLT using capnograph.
Prazo: The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.
|
|
Respiratory rate (rpm) during CWLT with noninvasive ventilation using ventilator monitoring.
Prazo: The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 2 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
|
Inspiratory tidal volume (Vti, in liter) during CWLT with noninvasive ventilation using ventilator monitoring.
Prazo: The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 2 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
|
Leak (liter per minute) during CWLT with noninvasive ventilation using ventilator monitoring.
Prazo: The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Outcome will be continuously recorded.
Results will be shown at Tlim (Tlim for the 2 tests) and iso time (defined as the Tlim or the shortest test).
|
The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Ventilatory asynchronism during CWLT with noninvasive ventilation using ventilator monitoring.
Prazo: The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Outcome will be continuously recorded.
|
The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: David Debeaumont, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
- Cadeira de estudo: Tristan Bonnevie, PT, MsC, ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
- Investigador principal: Catherine Viacroze, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
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 junho de 2016
Conclusão Primária (Real)
1 de fevereiro de 2018
Conclusão do estudo (Real)
1 de fevereiro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
30 de maio de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de junho de 2016
Primeira postagem (Estimativa)
10 de junho de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de janeiro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de janeiro de 2019
Última verificação
1 de janeiro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Exercise-NIV
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 .