Clinical trial NCT06620081: Effects of High-Flow Nasal Cannula on Exercise Outcomes in Lung Transplant Candidates: A Pilot Study
Official title: Effects of High-Flow Nasal Cannula on Exercise Outcomes in Lung Transplant Candidates: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Diseases
Oxygen Therapy
High-flow Nasal Cannula
Exercise Tolerance
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This pilot study is a randomized crossover clinical trial
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the effect of HFNC on the distance covered in the 6MWT
timeFrame: 24 months
measure: Effect of HFNC on CO2 kinetics.
timeFrame: 24 months
measure: Investigate the effect of HFNC on exercise-induced dynamic hyperinflation in patients on the lung transplant waiting list participating in a cardiopulmonary rehabilitation program.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Albert Einstein Israelite Hospital
Study officials:
affiliation: Albert Einstein Israelite Hospital
name: Elaine Cristina Pereira
role: STUDY_CHAIR
affiliation: Albert Einstein Israelite Hospital
name: José Eduardo Afonso Júnior
role: STUDY_CHAIR
affiliation: Albert Einstein Israelite Hospital
name: Melline Della Torre de Almeida
role: STUDY_CHAIR
affiliation: Albert Einstein Israelite Hospital
name: Priscila Borelli Pereira Leite
role: STUDY_CHAIR
affiliation: Albert Einstein Israelite Hospital
name: Thaise de Lucca Cappeline
role: STUDY_CHAIR
affiliation: Albert Einstein Israelite Hospital
name: Thaís Melatto Loschi
role: STUDY_CHAIR
affiliation: Albert Einstein Israelite Hospital
name: Vanuza Ferreira dos Santos
role: STUDY_CHAIR
affiliation: Albert Einstein Israelite Hospital
name: Luciana Diniz Nagem Janot de Matos
role: STUDY_DIRECTOR
References: