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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxygen therapyHigh flow nasal cannula | Experimental | High-Flow Nasal Cannula Therapy (HFNC Therapy). |
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| Conventional oxygen therapy | Active Comparator | Conventional Oxygen Therapy with Venturi Mask or Non-Rebreather Mask. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| ThaÃs 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein Israelite Hospital | São Paulo | 05652-900 | Brazil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2024 | Aug 13, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2019 | Aug 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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This pilot study is a randomized crossover clinical trial
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| 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. |
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