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Can High-Flow Oxygen Therapy Improve Oxygenation During Exercise in ILD Patients?

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ClinicalTrials.gov Identifier: NCT03287713
Recruitment Status : Not yet recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:

Objectives: 1.- To compare the level of oxygenation achieved during muscular training with conventional oxygen systems (nasal cannulas) versus nasal High-flow oxygen therapy. 2.-To compare benefits achieved with both systems, in terms of: level of exercise during training; effort tolerance in the 6 minutes walking test (6MWT); improvement of dyspnoea and Health-related quality of life (HRQoL). And analyse the effects of nasal High-flow oxygen therapy on the acute exercise in a subgroup of patients.

Method: Multicentric randomized clinical trial. Patients with ILD in fibrotic phase who present oxygen desaturation during 6MWT (SpO2 mean ≤ 85%) will be included consecutively. Will be randomized in two groups: ILD patients with conventional oxygen (EPIDOC) and ILD patients with nasal High-Flow oxygen therapy (EPIDOAF). Both groups will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated respectively to flow and FiO2 needed to maintain SpO2 ≥ 90% during training with both systems. Evaluation measures: SpO2 during training in both groups; dyspnoea (mMRC scale and CRQ dyspnoea); exercise capacity (6MWT) and HRQoL (self- administered KBILD questionnaire and SF36). In a subgroup of patients will be compared time of endurance exercise to evaluate the effects of nasal high-flow oxygen therapy in the acute exercise.


Condition or disease Intervention/treatment Phase
Intersticial Lung Disease Drug: oxygen therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can Nasal High-Flow Oxygen Therapy Improve Oxygenation During Exercise, Optimizing Benefits of Pulmonary Rehabilitation in Patients With Interstitial Lung Disease (ILD) With Exercise Desaturation?
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Active Comparator: Conventional oxygen (EPIDOC)
Patients randomized in conventional oxygen (EPIDOC) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to flow needed to maintain SpO2 ≥ 90% during training with both systems.
Drug: oxygen therapy
conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.

Active Comparator: Nasal High-Flow oxygen therapy (EPIDOAF)
Patients will be randomized in nasal High-Flow oxygen therapy (EPIDOAF) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to FiO2 needed to maintain SpO2 ≥ 90% during training with both systems.
Drug: oxygen therapy
conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.




Primary Outcome Measures :
  1. Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation [ Time Frame: 8 weeks ]
    To compare the level of oxygenation (in SatO2 %) achieved by conventional oxygen therapy and nasal high flow oxygen therapy during muscular training program in patients with ILD measured by pulseoxymetry.


Secondary Outcome Measures :
  1. Dyspnoea (benefits in borg scale) DURING effort. [ Time Frame: 8 weeks ]
    To compare the benefits in dyspnoea achieved by both systems in terms of Effort level during the training period measured by Borg Scale.

  2. Effort capacity (Benefits in terms of meters walked in the 6mwt). [ Time Frame: 8 weeks ]
    To compare the benefits achieved by both systems in terms of Effort tolerance after PR program, evaluated with the 6 minut waking test (6WT), in meters.

  3. Basal dyspnoea (mesured by mMRC scale). [ Time Frame: 8 weeks ]
    To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by mMRC scale.

  4. Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire). [ Time Frame: 8 weeks ]
    To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by the dyspnoea area of CRQ questionnaire.

  5. Quality of life (SF36 questionnaire). [ Time Frame: 8 weeks ]
    To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with SF36 questionnarire).

  6. Quality of life (KBILD questionnaire). [ Time Frame: 8 weeks ]
    To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with KBILD questionnaire).



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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 30 years old
  • Diagnostic of ILD according to the national and international guidelines 23
  • Being clinically stable the previous 4 weeks
  • Acceptance to participate in the trial

Exclusion Criteria:

  • Have been enrolled in a PR program in the last previous 6 months
  • Respiratory Diseases other than ILD or severe comorbidities
  • Osteoarticular diseases which don't allow training
  • End-stage ILD, treatment with opiates or survival < 6 months
  • Cognitive alterations that preclude colaboration

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03287713     History of Changes
Other Study ID Numbers: IIBSP-OXI-2017-18
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases