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Extremes of Respiratory Effort in Weaning Failure From Mechanical Ventilation: a Prospective Observational Study

NCT06464224 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2024-07-23

No results posted yet for this study

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.

Conditions

  • Mechanical Ventilation Pressure High
  • Weaning Failure

Interventions

BEHAVIORAL

low respiratory effort

patients under respiratory effort lower than -1,5 cmH2O (P0,1) and/or -7 cmH2O (Pocc)

BEHAVIORAL

high respiratory effort

patients under respiratory effort higher than -3,5 cmH2O (P0,1) and/or -15 cmH2O (Pocc)

Sponsors & Collaborators

  • Universidade Federal do Rio de Janeiro

    lead OTHER

Principal Investigators

  • Bruno Vilaça · manager of Physical Therapy team

  • Bruno Guimarães · manager of physical therapy team

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-01-31
Completion
2026-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06464224 on ClinicalTrials.gov