Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464224
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-12
Brief Title:
Extremes of Respiratory Effort in Weaning Failure From Mechanical Ventilation a Prospective Observational Study
Sponsor:
Universidade Federal do Rio de Janeiro
Organization:
Universidade Federal do Rio de Janeiro
Study Overview
Official Title:
Are the Extremes of Respiratory Efforts During Assisted Ventilation Associated With Weaning Failure in Critical Ill Patients a Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 P01 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 78185823400005249 Prospective multicenter observational study carried out in the ICUs of Glória Dor and Niteroi Dor 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 P01 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 78185823400005249 Prospective multicenter observational study carried out in the ICUs of Glória Dor and Niteroi Dor 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 Fishers 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 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None