Effect of High Flow Nasal During Exercise in COPD Patients

COPD Exacerbation Clinical Trial

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Official title:

Acute Effects of High Flow Nasal Support During Exercise in Patients With COPD After Severe Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058081
• Other study ID #: 2016-A01325-46
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 18, 2018

Study information

• Verified date: May 2018
• Source: Groupe Hospitalier du Havre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. High flow ventilation in reducing work of breathing and dyspnea may improve exercise tolerance. The aim of this study is to carry out the acute effect of high flow nasal cannula on exercise endurance in post-exacerbation copd patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 18, 2018
• Est. primary completion date: June 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• a diagnosis of COPD

Exclusion Criteria:

• exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.

• pH < 7,35

• Body temperature > 38°C

• cardiac frequency > 100 bpm at rest

• systolic blood pressure < 100 mmHg

• exacerbation during the study

Related Conditions & MeSH terms

• COPD Exacerbation

Intervention

Device:
• High Flow nasal cannula
High intensity Constant Work-Rate exercise test with High Flow Nasal Cannula in COPD patients involved in a Pulmonary Rehabilitation Program after an exacerbation (< 7 days after hospital discharge). High Flow nasal will be administered through nasal cannula using the Airvo2 (Fisher&Paykel)

Locations

Country	Name	City	State
France	Groupe Hospitalier du Havre	Montivilliers

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in exercise capacity	Difference in endurance time (TLim) during High Intensity Constant Work-Rate Endurence Test (CWRET)	The outcome will be measure after every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum
Secondary	Difference in peripheral muscle oxygenation	Muscle oxygenation will be evaluated using Near-infrared spectroscopy technology.	The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise
Secondary	Difference in Dyspnea and muscular fatigue	Difference in dyspnea and muscular fatigue using Modified Borg Scale (0 - 10 points)	The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be collected every 2 minute during tests and at the end of the exercise
Secondary	Difference in Oxygen Saturation	Difference in Oxygen Saturation using a pulse oximetry (SpO2)	The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise
Secondary	Difference in Cardiac Frequency	Difference in Cardiac Frequence using a pulse oximetry	The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise
Secondary	Difference in Transcutaneous Carbon Dioxide	Difference Transcutaneous Carbon Dioxide using Transcutaneous Carbon Dioxide using a Transcutaneous capnography	The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise
Secondary	Difference in Respiratory Rate	Difference in Respiratory Rate using a Respiratory Inductive Plethysmography	The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise
Secondary	Difference in Respiratory Muscle Fatigue	Difference in Respiratory Muscle Fatigue using an electronical manometer	The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be collected before and 5 minute maximum after exercise