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

Weaning Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06464224
• Other study ID #: 78185823.4.0000.5249
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: Universidade Federal do Rio de Janeiro
• Contact: Amanda Pereira da cruz
• Phone: 21971739472
• Email: amanda_pereiradacruz[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 observational study, carried out in the ICUs of Hospital Glória D'or, 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.

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 pulmonary 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; In-hospital mortality rate. Methodology: CAAE: 78185823.4.0000.5249; Prospective observational study, carried out in the ICUs of Hospital Glória D'or, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: July 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mechanical Ventilation Pressure High
• Weaning Failure

Intervention

Behavioral:
• low respiratory effort
patients under respiratory effort lower than -1,5 (P0,1) and/or -7 (Pocc)
• high respiratory effort
patients under respiratory effort higher than -3,5 (P0,1 and/or -15 (Pocc)

Locations

Country	Name	City	State
Brazil	Gloria D'or hospital	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weaning rate from mechanical ventilation	weaning rate from mechanical ventilation	2 years
Secondary	days outside the MV (in the 28-day interval)	days outside the MV (in the 28-day interval)	2 years
Secondary	Total weaning time (first attempt until success)	Total weaning time (first attempt until success)	2 years
Secondary	Rate and time for tracheostomy	Rate and time for tracheostomy	2 years
Secondary	Length of stay in the ICU and hospital	Length of stay in the ICU and hospital	2 years
Secondary	In-hospital mortality rate	In-hospital mortality rate	2 years