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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversidade Federal do Rio de Janeiro

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

• Neuromuscular disease;

Phrenic nerve injury;

MV for less than 24 hours;

Previously tracheostomized patient;

Trial population

Patients under mechanical ventilation in their first seven days in spontaneous ventilation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • low respiratory effort

    Behavioral

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

  • high respiratory effort

    Behavioral

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

Treatment groups

1 Participants
are divided into 2 treatment groups
Group A: low respiratory effort1 intervention
Group B: high respiratory effort1 intervention

Trial outcomes

Primary outcomes

1

weaning rate from mechanical ventilation

weaning rate from mechanical ventilation (%)

Time frame
2 years

Secondary outcomes

1

days outside the MV (in the 28-day interval)

days outside the MV (in the 28-day interval)

Time frame
2 years
2

Total weaning time (first attempt until success)

Total weaning time (first attempt until success) (days)

Time frame
2 years
3

Rate and time for tracheostomy

Rate and time for tracheostomy (%)

Time frame
2 years
4

Length of stay in the ICU and hospital

Length of stay in the ICU and hospital (days)

Time frame
2 years

Other outcomes

Sponsors and contacts

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