Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617078
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-01-02
Brief Title:
Benefit of High-flow Nasal Cannula on Persistent Dyspnea in Ild
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Benefit of High-flow Nasal Cannula on Persistent Dyspnea in Interstitial Lung Disease Randomized Multicentric Cross-over Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIGHOXFILD
Brief Summary:
The main purpose of this study is to evaluate the effects of high-flow nasal therapy HFNT oxygen compared to long-term oxygen therapy LTOT on dyspnea and quality of life in intersititial lung disease patients with chronic respiratory failure and persistent breathlessness in whom LTOT has already been initiated
Detailed Description:
The study will be a non-blinded two-arm crossover 2 periods of 2 weeks each randomised controlled superiority multicentre trial comparing the effect of HFNT on persistent dyspnoea in intersititial lung disease patients with chronic respiratory failure as compared to LTOT over a two-week period The oxygen flow rate with HFNT will be the same as for usual care The HFNT will be used during the night and during the 3-minute chair rise test it can be used during the day depending on the patients needs During the rest of the time the LTOT will be used as in usual care Participants will be randomised to receive 1 2 weeks of LTOT then 2 weeks of LTOTHFNT or 2 2 weeks of LTOTHFNT then 2 weeks of LTOT The investigators will determine the effect of HFNT on quality of life and dyspnoea The investigators will also study the effect of HFNT on secondary outcomes listed below Each assessment will be performed at the end of each 2-week period Polysomnography will be optional The study will be conducted in 42 patients with LTOT suffering from persistent breathlessness
With a total sample of 38 patients and a crossover design if the real difference on the Saint Georges Respiratory Questionnaire SGRQ is 6 the standard deviation of the matched difference is 125 and the significance threshold is 5 a two-tailed Students t test will have a power of 80 to conclude that the difference is significantly different from 0 Calculated using PASS 14014 Analysis of a cross-over design using differenceThese hypotheses are based on the values observed in the article by Nagata et al PMID 29283682 in patients with Chronic Obstructive Pulmonary Diseaes of the same severity which reported an improvement in the SGRQ-s of -108 95 CI -153 -63 ie SD of 124 with HFNT administered at night for 6 weeks versus LTOT Another study PMID 31308647 reported an improvement of -119 CI95 -172 -66 after an introduction of HFNT As the minicmal clinical improvement difference for SGRQ is 4 a difference of 6 is considered was both realistic and clinically relevant A Students t test allows a conservative approach compared to the use of a linear mixed-effects model retained for the analysis of the primary endpoint
To take account of reduced precision due to possible loss of follow-up or study withdrawals the sample was increased by 10 ie 42 patients 21 in the HFNTLTOT then LTOT sequence and 21 in the LTOT then HFNTLTOT sequence
With a total sample of 38 patients and a crossover design if the real difference on the Saint Georges Respiratory Questionnaire SGRQ is 6 the standard deviation of the matched difference is 125 and the significance threshold is 5 a two-tailed Students t test will have a power of 80 to conclude that the difference is significantly different from 0 Calculated using PASS 14014 Analysis of a cross-over design using differenceThese hypotheses are based on the values observed in the article by Nagata et al PMID 29283682 in patients with Chronic Obstructive Pulmonary Diseaes of the same severity which reported an improvement in the SGRQ-s of -108 95 CI -153 -63 ie SD of 124 with HFNT administered at night for 6 weeks versus LTOT Another study PMID 31308647 reported an improvement of -119 CI95 -172 -66 after an introduction of HFNT As the minicmal clinical improvement difference for SGRQ is 4 a difference of 6 is considered was both realistic and clinically relevant A Students t test allows a conservative approach compared to the use of a linear mixed-effects model retained for the analysis of the primary endpoint
To take account of reduced precision due to possible loss of follow-up or study withdrawals the sample was increased by 10 ie 42 patients 21 in the HFNTLTOT then LTOT sequence and 21 in the LTOT then HFNTLTOT sequence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None