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Effect of high-flow nasal cannula on functional exercise capacity in hospitalized adult lung transplant candidates: a modified cross-over study

Effect of high-flow nasal cannula on the 6-minute walk test in hospitalized patients with pulmonary hypertension or pulmonary fibrosis who are candidates for lung transplantation: a modified cross-over study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN19429702
Enrollment
30
Registered
2025-01-20
Start date
2024-08-15
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospitalised adults with pulmonary hypertension or pulmonary fibrosis who are candidates for lung transplantation Respiratory

Interventions

The study participants will perform four 6MWTs: one with supplemental oxygen delivered via reservoir mask and three with high-flow nasal cannula at 40, 50 or 60 LPM. An inspired fraction of oxygen wil

Sponsors

Instituto Nacional del Tórax
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult persons (18 years of age or older) 2. Persons with a group I or III pulmonary hypertension diagnosis as defined by the World Health Organization (WHO). Diagnosis can be made by echocardiogram or cardiac catheterization 3. Persons with a diagnosis of pulmonary fibrosis. Diagnosis may be made by computed tomography (CT) or lung biopsy 4. Persons under study to enter the lung transplant list or enlisted at the time of study execution 5. Stable medical condition, defined as no change in medication in the last 14 days before assessment 6. Indication from the treating medical team to perform out-of-bed motor rehabilitation 7. Having previously undergone a 6MWT

Exclusion criteria

Exclusion criteria: 1. Persons with exacerbation of pathology due to infectious, inflammatory process or disease progression 2. Persons with a resting heart rate greater than 120 beats per minute 3. Persons with unstable hemodynamics (MAP 100 mmHg) 4. Persons connected to a high-flow nasal cannula with flows equal to or greater than 40 LPM at rest 5. Persons in need of continuous or intermittent connection to noninvasive mechanical ventilation 6. Persons with neuromusculoskeletal alterations or need for technical aids that limit independent walking 7. Persons who do not understand the instructions necessary to perform the 6MWT 8. Persons who do not sign the informed consent

Design outcomes

Primary

MeasureTime frame
Functional capacity to perform exercise: the distance walked in each 6MWT will be measured. nt. The four tests will be performed at an interval of 3 days.

Secondary

MeasureTime frame
1. Physiological response to physical exertion: 1.1. Respiratory rate will be monitored with a multiparameter transport monitor every minute during all 6MWT and at 1, 3, 6, and 10 minutes after the end of the tests. 1.2. Heart rate will be monitored with a multiparameter transport monitor every minute during all 6MWT and at 1, 3, 6, and 10 minutes after the end of the tests. 1.3. Peripheral oxygen saturation will be monitored with a multiparameter transport monitor every minute during all 6MWT and at 1, 3, 6, and 10 minutes after the end of the tests. 1.4. Lower extremity fatigue will be assessed with a simple numerical scale (NRS) from 0 to 10 every minute during all 6MWT and at 1, 3, 6, and 10 minutes after the end of the tests. 1.5. Dyspnea will be assessed with the modified Borg scale every minute during all 6MWT and at 1, 3, 6, and 10 minutes after the end of the tests. 2. Stops during the 6MWT: stops during each test will be counted, and the patient will be asked for the reasons. 3. Walking time: Patients' total walking time will be determined. This time will be calculated by subtracting the time spent stopped from the total time of the 6MWT (6 minutes). 4. Time to return to calm: when vital signs, lower extremity fatigue and dyspnea return to baseline values will be determined. This will be assessed up to minute 10 of each 6MWT. 5. Adverse events: adverse events directly associated with the performance of the 6MWT will be recorded. Falls, syncope, and increases in oxygen requirements and respiratory support during the same day of the four 6MWTs will be considered. Deaths and the need for invasive mechanical ventilation or extracorporeal circulatory support will also be considered.

Countries

Chile

Contacts

Public ContactRuvistay Gutierrez-Arias
rgutierrez@torax.cl+56 (0)2 25755000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026