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

September 26, 2024 updated by: Hospital Israelita Albert Einstein
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05652-900
        • Albert Einstein Israelite Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxygen therapyHigh flow nasal cannula
High-Flow Nasal Cannula Therapy (HFNC Therapy).
Other: Performance Tests
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.
Other: Functional Tests
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.
Active Comparator: Conventional oxygen therapy
Conventional Oxygen Therapy with Venturi Mask or Non-Rebreather Mask.
Other: Performance Tests
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.
Other: Functional Tests
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of HFNC on the distance covered in the 6MWT
Time Frame: 24 months
Assessment of the distance traveled in 6 minutes.
24 months
Effect of HFNC on CO2 kinetics.
Time Frame: 24 months
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.
Time Frame: 24 months
Assessment of high-flow therapy in effort-induced hyperinflation.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Study Chair: 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 Director: Luciana Diniz Nagem Janot de Matos, Albert Einstein Israelite Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

July 24, 2024

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 26, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26495219.1.0000.0071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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