- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03568747
Efficacy and Mechanism of NIV in Relieving Dyspnea After Exercise in Patients With Stable Severe COPD
29. juli 2019 opdateret af: Yonger Ou, Guangzhou Institute of Respiratory Disease
Efficacy and Mechanism of Non-invasive Ventilation in Relieving Dyspnea After Exercise in Patients With Stable Severe Chronic Obstructive Pulmonary Disease
Exertional dyspnea is a major cause of exercise limitation and anxiety, and contributes importantly to reduced quality of life for patients with COPD.
The aim of this study is to determine the efficacy and mechanism of NIV with a dual-limb circuit plus oxygen therapy in relieving exertional dyspnea in patients with severe COPD, so as to provide a guidance for clinical use for NIV.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Exertional dyspnea was the most characteristic respiratory symptoms in patients with chronic obstructive pulmonary disease (COPD), it is a major cause of exercise limitation and anxiety, and contributes importantly to reduced quality of life for patients with COPD.
COPD patients often unconsciously adopt a sedentary lifestyle, probably due to distressing exertional dyspnea.
The sedentarism results in physical deconditioning and alterations of the peripheral muscles, which leads to a vicious circle and contribute to the debilitation of the patients.
Thereby, intervention should be taken to intervene this vicious cycle.
It has been reported that noninvasive ventilation (NIV) could help unload the inspiratory muscle, improve dynamic pulmonary hyperinflation, improve neuro-mechanical coupling, oxygenation, and thus relieved dyspnea during exercise in COPD patients.
However, in these reports, NIV was used as add-on therapy during exercise or at resting condition before exertional dyspnea occurred.
So far, there's few studies on the efficacy of NIV used at the time of exertional dyspnea occurred as the rescue therapy to relieve dyspnea after exercise in patients with stable severe COPD while the patients are already undergoing optimal treatment with bronchodilator and anti-inflammatory medication, which might relieve their physiological and perceptional burden to limit their activities.
The result of the investigators previous study has suggested that compared with oxygen therapy, NIV plus oxygen therapy resulted in decrease in dyspnea intensity at isotime, however, there's no statistically significant shortening in total dyspnea recovery time and NIV was not helpful in all the COPD patients.
In another study, it was indicated that ventilated by a single-limb tubing with a plateau exhalation valve (PEV) caused CO2 rebreathing to COPD patients during exercise.
CO2 rebreathing may have a negative impact on efficacy.
Previous studies have proved that exercise tolerance was improved ventilated by noninvasive ventilation with a dual-limb circuit.
In theory, NIV with a dual-limb circuit consists of one inhalation limb that introduces air into the patient's airways and one exhalation limb that leads exhaled gas outside of the airways, there is no risk of rebreathing.
However, it is unclear whether NIV with a dual-limb circuit could be used at the time of exertional dyspnea occurred as rescue therapy to relieve dyspnea after exercise in patients with stable severe COPD and what are the mechanisms.
The purpose of this study was therefore to determine whether assisted with NIV with dual-limb circuit in patients with stable severe COPD after exercise with exertional dyspnea (1)dyspnea was relieved after exercise in patients with stable severe COPD; (2)the repiratory mechanism.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Guangdong
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Guangzhou, Guangdong, Kina, 510000
- The First Affiliated Hospital of Guangzhou Medical University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- severe COPD (post bronchodilator FEV1/FVC < 70% and FEV1 < 50% predicted)
- stable clinical condition(no exacerbation in the 4 weeks prior to study participation with no change in medications)
- dyspnea as a main symptom that limited daily activities
Exclusion Criteria:
- obvious pulmonary bullae demonstrated by chest CT scan or X-ray examination facial trauma/malformation; recent facial, upper airway or upper gastrointestinal tract surgery
- systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg at rest
- unstable angina or a myocardial infarct in the previous four weeks
- resting sinus tachycardia ( > 120 beats/min)
- patients with musculoskeletal or neurological disorders
- patients who are unable to give informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: NIV plus oxygen therapy
noninvasive ventilation (dual-limb NIV) is given at peak exercise until the borg scale reaches it's baseline point
|
dual-limb circuit NIV were given on maquet servo i apparatus
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Eksperimentel: oxygen therapy
oxygen therapy is given at peak exercise until the borg scale reaches it's baseline point
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oxygen therapy were introduced to the side port of the facemask
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
change from baseline Borg scale to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
this is a scale that asks the participants to rate the difficulty of breathing.
It starts at number 0 where one's breathing is causing no difficulty at all and progresses through to number 10 where one's breathing difficulty is maximal.
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
change from baseline diaphragm electromyogram to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
EMGdi
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline index of neuromechanical dissociation of the respiratory system to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
EMGdi%max:Vt%VCpred
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
change from baseline transdiaphragmatic pressure to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
Pdi
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline esophageal pressure to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
Pes
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline mouth pressure to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
Pm
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline inspiratory capacity to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
IC
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline minute ventilation to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
VE
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline oxygen saturation to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
SpO2
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline heart rate to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
HR
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline total recovery time to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
total recovery time
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline tidal volume to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
Vt
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline respiratory rate to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
RR
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline inspiratory time to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
Ti
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline total duty cycle to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
Ttot
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline expiratory time to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
Te
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline pressure time product to complete recovery after exercise
Tidsramme: baseline, at peak exercise and at every 30s interval until complete recovery
|
PTP
|
baseline, at peak exercise and at every 30s interval until complete recovery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Rongchang Chen, The First Affiliated Hospital of Guangzhou Medical University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. juni 2018
Primær færdiggørelse (Faktiske)
3. februar 2019
Studieafslutning (Faktiske)
30. april 2019
Datoer for studieregistrering
Først indsendt
30. maj 2018
Først indsendt, der opfyldte QC-kriterier
14. juni 2018
Først opslået (Faktiske)
26. juni 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juli 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juli 2019
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GIRD201801
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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