RecruitingNCT06464224

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

Are the Extremes of Respiratory Efforts During Assisted Ventilation Associated With Weaning Failure in Critical Ill Patients: a Prospective Observational Study


Sponsor

Universidade Federal do Rio de Janeiro

Enrollment

1 participants

Start Date

Apr 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria12

  • 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.

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Interventions

BEHAVIORALlow respiratory effort

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

BEHAVIORALhigh respiratory effort

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


Locations(1)

Gloria D'or hospital

Rio de Janeiro, Brazil

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NCT06464224


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