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

NCT06620081 | Completed DMC

• 1 other identifier: 26495219.1.0000.0071
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Evaluate the effect of HFNC on the distance covered in the 6MWT

  Assessment of the distance traveled in 6 minutes.

  24 months

• Effect of HFNC on CO2 kinetics.

  Assessment of the kinetics of effort-induced carbon dioxide.

  24 months

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

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

  24 months

Study Arms (2)

Oxygen therapyHigh flow nasal cannula

EXPERIMENTAL

High-Flow Nasal Cannula Therapy (HFNC Therapy).

Other: Performance Tests; Other: Functional Tests

Conventional oxygen therapy

ACTIVE COMPARATOR

Conventional Oxygen Therapy with Venturi Mask or Non-Rebreather Mask.

Other: Performance Tests; Other: Functional Tests

Interventions

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.

Conventional oxygen therapy; Oxygen therapyHigh flow nasal cannula

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.

Conventional oxygen therapy; Oxygen therapyHigh flow nasal cannula

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Albert Einstein Israelite Hospital

São Paulo, 05652-900, Brazil

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Elaine Cristina Pereira

  Albert Einstein Israelite Hospital

  STUDY CHAIR

• José Eduardo Afonso Júnior

  Albert Einstein Israelite Hospital

  STUDY CHAIR

• Melline Della Torre de Almeida

  Albert Einstein Israelite Hospital

  STUDY CHAIR

• Priscila Borelli Pereira Leite

  Albert Einstein Israelite Hospital

  STUDY CHAIR

• Thaise de Lucca Cappeline

  Albert Einstein Israelite Hospital

  STUDY CHAIR

• Thaís Melatto Loschi

  Albert Einstein Israelite Hospital

  STUDY CHAIR

• Vanuza Ferreira dos Santos

  Albert Einstein Israelite Hospital

  STUDY CHAIR

• Luciana Diniz Nagem Janot de Matos

  Albert Einstein Israelite Hospital

  STUDY DIRECTOR

Study Design

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

Model Details: This pilot study is a randomized crossover clinical trial

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: October 1, 2024
• Study Start: June 2, 2021
• Primary Completion: March 31, 2023
• Study Completion: July 24, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)