|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
25 April 2022 |
|
Main ID: |
NCT03965832 |
|
Date of registration:
|
24/05/2019 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
HFNT During Exercise in CF
|
|
Scientific title:
|
A Pilot Study to Evaluate the Feasibility of Using High-flow Nasal Therapy During Exercise in Patients With Cystic Fibrosis and Severe Lung Disease |
|
Date of first enrolment:
|
May 24, 2019 |
|
Target sample size:
|
23 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03965832 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
Daniel G Peckham |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
LTHT |
|
|
Name:
|
Giulia Spoletini |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
LTHT |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Diagnosis of CF
- Severe lung disease (FEV1 =40%)
Exclusion Criteria:
- Acute viral illness
- Requirements of >6 L/min nasal O2 to maintain SpO2 >88% at rest
- Acute respiratory acidosis
- Arthritis exacerbation
- Inability to obtain informed consent
- Recent pneumothorax (<6 weeks)
- Usual contraindication to exercise testing
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cystic Fibrosis
|
|
Intervention(s)
|
|
Device: HFNT during exercise
|
|
Device: Standard oxygen therapy/RA
|
|
Primary Outcome(s)
|
|
6 minute walking distance
[Time Frame: 6 minutes]
|
|
Secondary ID(s)
|
|
RM19/121917
|
|
19/LO/0671
|
|
262095
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|