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Noninvasive ventilation after extubation: a randomized clinical trial

Clinical outcomes and adverse events of noninvasive ventilation after extubation: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7zmskk9
Enrollment
Unknown
Registered
2025-06-02
Start date
2025-04-01
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

Respiratory failure

Interventions

This is a randomized clinical trial with two arms, not blinded for outcome measurement. The study population will consist of men and women admitted to an intensive care unit, and who have undergone in

Sponsors

Universidade Regional do Noroeste do Estado do Rio Grande do Sul - UNIJUI
Lead Sponsor
Universidade Regional do Noroeste do Estado do Rio Grande do Sul - UNIJUI
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Over 18 years of age; both genders; intubated patients; more than 24 hours on an invasive ventilatory system; tolerate spontaneous breathing test with Tayre connected to oxygen therapy support; arterial blood gases in stable state

Exclusion criteria

Exclusion criteria: Pregnancy; existing spinal cord injury; neurodegenerative diseases; need for emergency intubation; cardiac or respiratory arrest; facial and cranial trauma or surgery; tracheostomy; recent oral gastric or esophageal surgery; upper gastrointestinal bleeding; excessive amount of respiratory secretions; uncooperative patient; presence of hearing and vision deficits; patient who does not tolerate the spontaneous breathing test and previous medical decision to limit therapeutic effort

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study will be the incidence of adverse events associated with noninvasive ventilation, assessed by questionnaire. A higher incidence of adverse events is expected in the group receiving continuous and uninterrupted noninvasive ventilation

Secondary

MeasureTime frame
Evaluation of the effectiveness of noninvasive ventilation, considering the success rate of extubation and the reintubation rate in the first 48 hours. The same effectiveness is expected in both protocols, with better patient adherence to noninvasive ventilation in an interval manner; a better level of patient comfort, measured by the visual analogue scale. Total length of stay in the intensive care unit (days). Total length of hospital stay (days). In-hospital mortality rate (days). Blood gas analysis: hydrogen ion potential), partial pressure of oxygen, partial pressure of carbon dioxide and sodium bicarbonate before extubation, 1 hour after the installation of noninvasive ventilation and another hour after the withdrawal of noninvasive ventilation, at the end of both protocols. Hemodynamic data: peripheral oxygen saturation, systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate before extubation, 1 hour after installation of non-invasive ventilation and another after removal of non-invasive ventilation, at the end of both protocols

Countries

Brazil

Contacts

Public ContactEdina Steffens

Universidade Regional do Noroeste do Estado do Rio Grande do Sul - UNIJUI

edinasteffens@gmail.com+55 (55)999339321

Outcome results

None listed

Source: REBEC (via WHO ICTRP)