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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06620081
Enrollment
10
Registered
2024-10-01
Start date
2021-06-02
Completion date
2024-07-24
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Diseases, Oxygen Therapy, High-flow Nasal Cannula, Exercise Tolerance

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.

Interventions

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: HFNC and conventional oxygen therapy, totaling six test days. The inspired oxygen fraction (FiO2) was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces.

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: HFNC and conventional oxygen therapy, totaling six test days. The inspired oxygen fraction (FiO2) was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces.

Sponsors

Hospital Israelita Albert Einstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

This pilot study is a randomized crossover clinical trial

Eligibility

Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the effect of HFNC on the distance covered in the 6MWT24 monthsAssessment of the distance traveled in 6 minutes.
Effect of HFNC on CO2 kinetics.24 monthsAssessment 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 monthsAssessment of high-flow therapy in effort-induced hyperinflation.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026