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

NCT ID: NCT03287713

Last Updated: 2017-09-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2021-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intersticial Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

oxygen therapy

Intervention Type DRUG

conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.

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.

Group Type ACTIVE_COMPARATOR

oxygen therapy

Intervention Type DRUG

conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.

Interventions

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oxygen therapy

conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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IIBSP-OXI-2017-18

Identifier Type: -

Identifier Source: org_study_id