Effects of High-Flow Nasal Cannula on Exercise Outcomes in Lung Transplant Candidates: A Pilot Study

Not Applicable

Completed

• Conditions: Pulmonary Diseases; Oxygen Therapy; High-flow Nasal Cannula; Exercise Tolerance
• Interventions: Other: Performance Tests; Other: Functional Tests

• Registration Number: NCT06620081
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

The study evaluated patients on the national lung transplant waiting list. It was pioneering in assessing high-complexity patients with severe pulmonary diseases subjected to a cardiopulmonary rehabilitation protocol using a treadmill. The main findings indicate that the distance covered in the six-minute walk test was greater when using the high-flow nasal cannula supplementation. The improvement in exercise performance in this group is associated with a reduction in arterial carbon dioxide, optimization of hydrogen potential, and a decrease in dynamic hyperinflation, leading to fewer symptoms of dyspnea.

Detailed Description

Introduction: Pulmonary diseases have a significant global prevalence, and lung transplantation is indicated for advanced cases. Rehabilitation is essential for patients on the waiting list and requires ventilatory devices for symptom control during exertion. The high-flow nasal cannula is a promising alternative, but its effects on exercise outcomes are uncertain. Objectives: To assess the effects of high-flow nasal cannula on the outcomes of the six-minute walk test. Method: A randomized crossover clinical trial evaluated ten volunteers listed on the national lung transplant waiting list. Three functional tests were performed: the six-minute walk test, incremental lower limb test with arterial blood gas analysis, and lower limb endurance test with inspiratory capacity measurement. Each test was conducted on different days with different devices: high-flow nasal cannula and conventional oxygen therapy, totaling six test days. The inspired oxygen fraction was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces.

Study Timeline

• Study Start: 2021-06-02
• Primary Completion: 2023-03-31
• Status Verified: 2024-07
• Study Completion: 2024-07-24
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Volunteers of both sexes
• Patients on the national lung transplant waiting list
• Chronic obstructive pulmonary disease
• Idiopathic or familial pulmonary fibrosis
• Bronchiectasis
• Sarcoidosis

Exclusion Criteria

• Osteoarticular limitation,
• Neuromuscular disease,
• Anemia
• Hyperglycemia
• Arrhythmia
• Left heart failure
• Pulmonary hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxygen therapyHigh flow nasal cannula	Functional Tests	High-Flow Nasal Cannula Therapy (HFNC Therapy).
Conventional oxygen therapy	Performance Tests	Conventional Oxygen Therapy with Venturi Mask or Non-Rebreather Mask.
Conventional oxygen therapy	Functional Tests	Conventional Oxygen Therapy with Venturi Mask or Non-Rebreather Mask.
Oxygen therapyHigh flow nasal cannula	Performance Tests	High-Flow Nasal Cannula Therapy (HFNC Therapy).

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of HFNC on the distance covered in the 6MWT	24 months	Assessment of the distance traveled in 6 minutes.
Effect of HFNC on CO2 kinetics.	24 months	Assessment of the kinetics of effort-induced carbon dioxide.
Investigate the effect of HFNC on exercise-induced dynamic hyperinflation in patients on the lung transplant waiting list participating in a cardiopulmonary rehabilitation program.	24 months	Assessment of high-flow therapy in effort-induced hyperinflation.

Trial Locations

Locations (1)

Albert Einstein Israelite Hospital; 🇧🇷 São Paulo, Brazil