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

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.

Study Overview

• Status: Recruiting
• Conditions: Weaning Failure; Mechanical Ventilation Pressure High
• Intervention / Treatment: Behavioral: low respiratory effort; Behavioral: high respiratory effort

Detailed Description

Introduction: The presence of high levels of respiratory effort in patients under mechanical ventilation may worsen the adjacent lung injury even after adapting protective ventilation, potentially prolonging the MV period. 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 lung stress during the first 7 days of spontaneous ventilation. Secondary outcomes: 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; evaluate the variation in ventilation distribution through electrical impedance tomography with the extremes of Pocc and Pmus; analyze the fraction of diaphragmatic thickening and diaphragmatic excursion through diaphragmatic ultrasound at the upper and lower levels of Pocc and Pmus; In-hospital mortality rate. Methodology: 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, excluding if patients with neuromuscular disease; Phrenic nerve injury; MV for less than 24 hours; Previously tracheostomized patient; Age under 18; Use of neuromuscular blocker > 72h; COPD sufferer; Pregnancy; Patient under palliative care; COVID-19 pneumonia; Patients reintubated after extubation in this hospitalization for less than 3 weeks. Statistical analysis: the sample calculation showed an estimated value of 50 patients for two candidate predictor variables; variables will be reported as mean (SD), median (IQ 25 - 75%) or absolute and relative frequencies. The estimate of any association between variables of upper and lower extremes of effort and dynamic pulmonary stress, as well as the ventilatory parameters used will be evaluated with preliminary univariate analysis (chi-square test with Yates' correction or Fisher's exact test), followed by a model multivariate logistic regression analysis adjusted for all clinical variables at hospital admission. Survival time, as well as hospital admission time until the event, will be analyzed using Kaplan-Meier estimates; the log-rank test will be used to compare groups. Values of p < 0.05 will be considered statistically significant. 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.

• Study Type: Observational
• Enrollment (Estimated): 1

Contacts and Locations

• Study Contact: Name: Amanda Pereira da cruz; Phone Number: 21971739472; Email: amanda_pereiradacruz@yahoo.com.br
• Study Contact Backup: Name: Pedro Leme Silva; Phone Number: 2183430442; Email: pedroleme@biof.ufrj.br

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 22211230
    • Recruiting
    • Gloria D'or hospital
    • Contact: Amanda Pereira da cruz; Phone Number: 21971739472; Email: amanda_pereiradacruz@yahoo.com.br
    • Contact: Amanda Pereira da cruz; Phone Number: 55 21971739472; Email: amanda_pereiradacruz@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
low respiratory effort; patients under low respiratory effort	Behavioral: low respiratory effort; patients under respiratory effort lower than -1,5 cmH2O (P0,1) and/or -7 cmH2O (Pocc)
high respiratory effort; patients under high respiratory effort	Behavioral: high respiratory effort; patients under respiratory effort higher than -3,5 cmH2O (P0,1) and/or -15 cmH2O (Pocc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weaning rate from mechanical ventilation	weaning rate from mechanical ventilation (%)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
days outside the MV (in the 28-day interval)	days outside the MV (in the 28-day interval)	2 years
Total weaning time (first attempt until success)	Total weaning time (first attempt until success) (days)	2 years
Rate and time for tracheostomy	Rate and time for tracheostomy (%)	2 years
Length of stay in the ICU and hospital	Length of stay in the ICU and hospital (days)	2 years
In-hospital mortality rate	In-hospital mortality rate (%)	2 years
electrical impedance tomography	spontaneous breathing trial failure rate (%) evaluated by electrical impedance tomography	2 years
diaphragmatic ultrassound	spontaneous breathing trial failure rate (%) evaluated by diaphragmatic ultrassound	2 years

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Investigators: Study Chair: Bruno Vilaça, manager of physical therapy team; Study Chair: Bruno Guimarães, manager of physical therapy team

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: respiratory drive; respiratory effort
• Other Study ID Numbers: 78185823.4.0000.5249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No