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

NCT03287713 | Unknown DMC

• 1 other identifier: IIBSP-OXI-2017-18
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intersticial Lung Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (6)

• Dyspnoea (benefits in borg scale) DURING effort.

  8 weeks

• Effort capacity (Benefits in terms of meters walked in the 6mwt).

  8 weeks

• Basal dyspnoea (mesured by mMRC scale).

  8 weeks

• Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire).

  8 weeks

• Quality of life (SF36 questionnaire).

  8 weeks

Study Arms (2)

Conventional oxygen (EPIDOC)

ACTIVE COMPARATOR

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

Nasal High-Flow oxygen therapy (EPIDOAF)

ACTIVE COMPARATOR

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

Interventions

oxygen therapy DRUG

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

Conventional oxygen (EPIDOC); Nasal High-Flow oxygen therapy (EPIDOAF)

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: September 19, 2017
• Study Start: January 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: September 19, 2017

Record last verified: 2017-09