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Comparison of the effects of two breathing aids, the high-flow nasal cannula and the venturi mask, on exercise tolerance in lung transplant candidates

Comparison of the effects of high-flow nasal cannula and venturi mask on exercise tolerance in lung transplant candidates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10gqsbsm
Enrollment
Unknown
Registered
2023-05-24
Start date
2019-01-22
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Lung Diseases

Interventions

There are two endurance tests, one with a high-flow nasal cannula and the other with a Venturi mask, which are scheduled seven days apart. Due to the cross design, all twelve participants receive thes
high-flow nasal cannula (total gas flow = 50 l/min, FiO2 = 50%) with a humidifier, snugly fitted to the nostrils and secured with an elastic band. Before performing the test, the participant remains w

Sponsors

Hospital de Messejana Dr Carlos Alberto Studart Gomes
Lead Sponsor
Hospital de Messejana Dr Carlos Alberto Studart Gomes
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Lung transplant candidates; both genders; older than 18 years; in initial evaluation for inclusion in a pulmonary rehabilitation program; with oxygen dependency or need for oxygen supplementation during the symptom-limited incremental load test performed before inclusion in the study

Exclusion criteria

Exclusion criteria: Candidates who did not comply with the protocol, because they were absent on the assessment day; candidates who did not present clinical conditions on the day of the test

Design outcomes

Primary

MeasureTime frame
Outcome found 1: A difference of 357 s (95% confidence interval – CI 181 – 533 s; p = 0.001) was found in exercise tolerance between the time achieved in the endurance test performed with the high-flow nasal cannula (937 s, 95% CI 668 – 1205 s) and the time achieved in the endurance test performed with the Venturi mask (580 s, 95% CI 403 – 756 s).;Expected outcome 1: It is expected to find a difference of at least 109 seconds in exercise tolerance between the time achieved in the endurance test performed with the high-flow nasal cannula and the time achieved in the endurance test performed with the Venturi mask.

Secondary

MeasureTime frame
Expected outcome 2: Absence of difference in the comparison of changes between pre- and post-endurance test, in physiological variables such as symptoms of dyspnea and lower limb fatigue, respiratory rate, peripheral oxygen saturation, heart rate, blood pressure and peripheral blood lactate level , between the two oxygen systems (high-flow nasal cannula and Venturi mask).;Outcome found 2: There was no statistically significant or clinically important difference in the comparison of changes between pre- and post-endurance test, in physiological variables such as symptoms of dyspnea and lower limb fatigue, respiratory rate, peripheral oxygen saturation, heart rate, blood pressure and peripheral blood lactate level, between the two oxygen systems (high-flow nasal cannula and Venturi mask).

Countries

Brazil

Contacts

Public ContactEmilia Rocha

Hospital de Messejana Dr Carlos Alberto Studart Gomes

emiliamatosrocha@yahoo.com.br+55(85)3101-4065

Outcome results

None listed

Source: REBEC (via WHO ICTRP)