Interfaces of Non-invasive Ventilation on Performance in Patients With Chronic Obstructive Pulmonary Disease (Exercise-NIV)
8 januari 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
21
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Bois-Guillaume, Frankrike
- ADIR Association
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Endurance time (Tlim, in second) during Constant Work Load Test (CWLT).
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Comfort of different masks using numerical scale (0-10) after exercising with noninvasive ventilation.
Tidsram: 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).
Tidsram: 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).
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ventilatory asynchronism during CWLT with noninvasive ventilation using ventilator monitoring.
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: David Debeaumont, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
- Studiestol: 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
- Huvudutredare: Catherine Viacroze, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2016
Primärt slutförande (Faktisk)
1 februari 2018
Avslutad studie (Faktisk)
1 februari 2018
Studieregistreringsdatum
Först inskickad
30 maj 2016
Först inskickad som uppfyllde QC-kriterierna
9 juni 2016
Första postat (Uppskatta)
10 juni 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 januari 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 januari 2019
Senast verifierad
1 januari 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Exercise-NIV
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .