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Noinvasive ventilation after extubation: a randomized clinical trial

Clinical outcomes and adverse events of non-invasive ventilation use after extubation: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7zmskk9
Enrollment
40
Registered
2025-06-02
Start date
2025-04-01
Completion date
Unknown
Last updated
2026-04-27

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
Assess comfort using a visual analog scale before, during, and after the use of non-invasive ventilation in both protocols

Secondary

MeasureTime frame
The incidence of adverse events associated with the use of NIV, assessed using the questionnaire method previously documented in the literature;Evaluation of the effectiveness of non-invasive ventilation, considering the extubation success rate and the reintubation rate in the first 48 hours;Total length of stay in the intensive care unit in days;Blood gas data obtained through blood gas analysis evaluating hydrogen ion potential, partial pressure of oxygen, partial pressure of carbon dioxide, and sodium bicarbonate before extubation, 1 hour after the initiation of non-invasive ventilation, and again after the removal of non-invasive ventilation, at the end of both protocols;Hemodynamic data assessing peripheral oxygen saturation, systolic blood pressure, diastolic blood pressure, heart rate, and respiratory rate before extubation, 1 hour after the start of non-invasive ventilation, and again after the removal of non-invasive ventilation, at the end of both protocols

Countries

BR

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) · Data processed: May 1, 2026