NCT06464224 Extremes of Respiratory Effort in Weaning Failure From Mechanical Ventilation: a Prospective Observational Study
| NCT ID | NCT06464224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidade Federal do Rio de Janeiro |
| Condition | Mechanical Ventilation Pressure High |
| Study Type | OBSERVATIONAL |
| Enrollment | 1 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1 participants in total. It began in 2024-04-01 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The presence of high levels of respiratory effort in patients under mechanical ventilation may worsen the adjacent lung injury even after adapting protective ventilation. Primary outcome: To evaluate the failure rate of weaning from IMV and its relationship with the lower and upper extremes of respiratory effort and the upper extreme of dynamic pulmonary stress during the first 7 days of spontaneous ventilation. Analyze the influence of these extremes based on the thresholds of Pocc, P0.1 and their derivatives Pmus, Ptp, din and MP: in relation to days off MV (in the 28-day interval); Total weaning time; Rate and time for tracheostomy; Length of stay in the ICU and hospital; In-hospital mortality rate. CAAE: 78185823.4.0000.5249. Prospective multicenter observational study, carried out in the ICUs of Glória D'or and Niteroi D'or hospitals, from January 2024 to July 2026, in patients over 18 years old, undergoing orotracheal intubation and IMV, in their first 7 days on spontaneous ventilation. Hypothesis: Extremes of respiratory effort and dynamic pulmonary stress would be associated with a higher rate of weaning from IMV, as well as longer time on IMV and subsequent longer hospital stay.
Eligibility Criteria
Inclusion Criteria: * Patients over 18 years old, admitted to the Glória D'or hospital, undergoing orotracheal intubation and invasive mechanical ventilation, in their first 7 years on spontaneous ventilation, who accept to participate in the study by signing the free and informed consent form (or by their legal responsible). Exclusion Criteria: * • Neuromuscular disease; * Phrenic nerve injury; * MV for less than 24 hours; * Previously tracheostomized patient; * Age under 18; * Use of neuromuscular blocker \> 72h; * COPD; * Patients with pulmonary fibrosis; * Pregnancy; * Patient under palliative care; * COVID-19 pneumonia; * Patients reintubated after extubation in this hospitalization for less than 3 weeks.
Contact & Investigator
Bruno Vilaça
STUDY CHAIR
manager of Physical Therapy team
Frequently Asked Questions
Who can join the NCT06464224 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mechanical Ventilation Pressure High. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06464224 currently recruiting?
Yes, NCT06464224 is actively recruiting participants. Contact the research team at amanda_pereiradacruz@yahoo.com.br for enrollment information.
Where is the NCT06464224 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil.
Who is sponsoring the NCT06464224 clinical trial?
NCT06464224 is sponsored by Universidade Federal do Rio de Janeiro. The principal investigator is Bruno Vilaça at manager of Physical Therapy team. The trial plans to enroll 1 participants.