Benefit of High-flow Nasal Cannula on Persistent Dyspnea in Ild
NCT ID: NCT06617078
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
42 participants
INTERVENTIONAL
2024-10-15
2026-10-15
Brief Summary
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Detailed Description
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With a total sample of 38 patients and a crossover design, if the real difference on the Saint George's Respiratory Questionnaire (SGRQ) is 6, the standard deviation of the matched difference is 12.5 and the significance threshold is 5%, a two-tailed Student's t test will have a power of 80% to conclude that the difference is significantly different from 0 (Calculated using PASS 14.0.14, Analysis of a cross-over design using difference).These 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 -10.8 (95% CI: -15.3; -6.3, i.e. SD of 12.4) with HFNT administered at night for 6 weeks versus LTOT Another study (PMID: 31308647) reported an improvement of -11.9 (CI95% -17.2; -6.6) 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 Student's 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%, i.e. 42 patients: 21 in the HFNT+LTOT then LTOT sequence and 21 in the LTOT then HFNT+LTOT sequence.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Long-Term Oxygen therapy (LTOT) then High Flow Nasal Therapy (HFNT)
2 weeks of LTOT then 2 weeks of LTOT+HFNT
long-term oxygen therapy (LTOT)
Usual care with LTOT for 2 weeks
High Flow Nasal Therapy (HFNT)
High Flow Nasal delivered by myAirvo3 (4 hours minimum and during th 3-minute chair rise test, 30L/min, 34°C, identical O2 flow rate as LTOT) for 2 weeks
High Flow Nasal Therapy (HFNT) then Long-Term Oxygen therapy (LTOT)
2 weeks of LTOT+HFNT then 2 weeks of LTOT
long-term oxygen therapy (LTOT)
Usual care with LTOT for 2 weeks
High Flow Nasal Therapy (HFNT)
High Flow Nasal delivered by myAirvo3 (4 hours minimum and during th 3-minute chair rise test, 30L/min, 34°C, identical O2 flow rate as LTOT) for 2 weeks
Interventions
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long-term oxygen therapy (LTOT)
Usual care with LTOT for 2 weeks
High Flow Nasal Therapy (HFNT)
High Flow Nasal delivered by myAirvo3 (4 hours minimum and during th 3-minute chair rise test, 30L/min, 34°C, identical O2 flow rate as LTOT) for 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Persistant dyspnea (mMRC≥3)
* Long-term oxygen therapy at least for 3 months
Exclusion Criteria
* Pneumothorax,
* Pneumomediastinum,
* Active smoker,
* Patient on non-invasive ventilation or continuous positive airway pressure (CPAP),
* Pregnancy or breastfeeding,
* Unable to read or understand questionnaires,
* No written consent,
* Patients under guardianship,
* No health assurance coverage
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Capucine Morélot-Panzini, MD,PhD, Prof
Role: PRINCIPAL_INVESTIGATOR
APHP • Assistance Publique des hôpitaux de Paris
Central Contacts
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Other Identifiers
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IDRCB
Identifier Type: OTHER
Identifier Source: secondary_id
APHP210079
Identifier Type: -
Identifier Source: org_study_id