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Completed

NCT Number: NCT06620081

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

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.

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Key information

Conditions

Pulmonary Diseases Exercise Tolerance High-flow Nasal Cannula Lung Diseases Oxygen Therapy Respiratory Tract Diseases

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein Israelite Hospital

São Paulo, 05652-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Performance Tests

Other

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.

functional tests

Other

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.

Primary outcomes

  1. Evaluate the effect of HFNC on the distance covered in the 6MWT

    Time frame: 24 months

    Assessment of the distance traveled in 6 minutes.

  2. Effect of HFNC on CO2 kinetics.

    Time frame: 24 months

    Assessment of the kinetics of effort-induced carbon dioxide.

  3. Investigate the effect of HFNC on exercise-induced dynamic hyperinflation in patients on the lung transplant waiting list participating in a cardiopulmonary rehabilitation program.

    Time frame: 24 months

    Assessment of high-flow therapy in effort-induced hyperinflation.

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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