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

Primary Purpose

Intersticial Lung Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oxygen therapy
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intersticial Lung Disease

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Conventional oxygen (EPIDOC)

    Nasal High-Flow oxygen therapy (EPIDOAF)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation
    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

    Dyspnoea (benefits in borg scale) DURING effort.
    To compare the benefits in dyspnoea achieved by both systems in terms of Effort level during the training period measured by Borg Scale.
    Effort capacity (Benefits in terms of meters walked in the 6mwt).
    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.
    Basal dyspnoea (mesured by mMRC scale).
    To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by mMRC scale.
    Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire).
    To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by the dyspnoea area of CRQ questionnaire.
    Quality of life (SF36 questionnaire).
    To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with SF36 questionnarire).
    Quality of life (KBILD questionnaire).
    To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with KBILD questionnaire).

    Full Information

    First Posted
    August 9, 2017
    Last Updated
    September 15, 2017
    Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03287713
    Brief Title
    Can High-Flow Oxygen Therapy Improve Oxygenation During Exercise in ILD Patients?
    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?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    January 2021 (Anticipated)
    Study Completion Date
    January 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intersticial Lung Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional oxygen (EPIDOC)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Nasal High-Flow oxygen therapy (EPIDOAF)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    oxygen therapy
    Intervention Description
    conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.
    Primary Outcome Measure Information:
    Title
    Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation
    Description
    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.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Dyspnoea (benefits in borg scale) DURING effort.
    Description
    To compare the benefits in dyspnoea achieved by both systems in terms of Effort level during the training period measured by Borg Scale.
    Time Frame
    8 weeks
    Title
    Effort capacity (Benefits in terms of meters walked in the 6mwt).
    Description
    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.
    Time Frame
    8 weeks
    Title
    Basal dyspnoea (mesured by mMRC scale).
    Description
    To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by mMRC scale.
    Time Frame
    8 weeks
    Title
    Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire).
    Description
    To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by the dyspnoea area of CRQ questionnaire.
    Time Frame
    8 weeks
    Title
    Quality of life (SF36 questionnaire).
    Description
    To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with SF36 questionnarire).
    Time Frame
    8 weeks
    Title
    Quality of life (KBILD questionnaire).
    Description
    To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with KBILD questionnaire).
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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