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

NCT06464224 | Recruiting

• 1 other identifier: 78185823.4.0000.5249
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Pressure High; Weaning Failure

Keywords

respiratory drive; respiratory effort

Outcome Measures

Primary Outcomes (1)

• weaning rate from mechanical ventilation

  weaning rate from mechanical ventilation (%)

  2 years

Secondary Outcomes (7)

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

  2 years

• Total weaning time (first attempt until success)

  2 years

• Rate and time for tracheostomy

  2 years

• Length of stay in the ICU and hospital

  2 years

• In-hospital mortality rate

  2 years

Study Arms (2)

low respiratory effort

patients under low respiratory effort

Behavioral: low respiratory effort

high respiratory effort

patients under high respiratory effort

Behavioral: high respiratory effort

Interventions

low respiratory effort BEHAVIORAL

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

low respiratory effort

high respiratory effort BEHAVIORAL

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

high respiratory effort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Gloria D'or hospital

Rio de Janeiro, 22211230, Brazil

RECRUITING

Study Officials

• Bruno Vilaça

  manager of Physical Therapy team

  STUDY CHAIR

• Bruno Guimarães

  manager of physical therapy team

  STUDY CHAIR

Central Study Contacts

Amanda Pereira da cruz

CONTACT

21971739472; amanda_pereiradacruz@yahoo.com.br

Pedro Leme Silva

CONTACT

2183430442; pedroleme@biof.ufrj.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Universidade Federal do Rio de Janeiro

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)