Clinical trial NCT06464224: Extremes of Respiratory Effort in Weaning Failure From Mechanical Ventilation: a Prospective Observational Study
Official title: Are the Extremes of Respiratory Efforts During Assisted Ventilation Associated With Weaning Failure in Critical Ill Patients: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mechanical Ventilation Pressure High
Weaning Failure
Keywords: respiratory drive
respiratory effort
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under mechanical ventilation in their first seven days in spontaneous ventilation

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: weaning rate from mechanical ventilation
timeFrame: 2 years
Secondary outcomes:
measure: days outside the MV (in the 28-day interval)
timeFrame: 2 years
measure: Total weaning time (first attempt until success)
timeFrame: 2 years
measure: Rate and time for tracheostomy
timeFrame: 2 years
measure: Length of stay in the ICU and hospital
timeFrame: 2 years
measure: In-hospital mortality rate
timeFrame: 2 years
measure: electrical impedance tomography
timeFrame: 2 years
measure: diaphragmatic ultrassound
timeFrame: 2 years
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Gloria D'or hospital
Study officials:
affiliation: manager of Physical Therapy team
name: Bruno Vilaça
role: STUDY_CHAIR
affiliation: manager of physical therapy team
name: Bruno Guimarães
role: STUDY_CHAIR
References: