Actively Recruiting
Are the Extremes of Respiratory Efforts During Assisted Ventilation Associated With Weaning Failure in Critical Ill Patients: a Prospective Observational Study
Led by Universidade Federal do Rio de Janeiro · Updated on 2024-07-23
1
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients over 18 years old who are receiving invasive mechanical ventilation (IMV) through orotracheal intubation. It aims to understand how extremes of respiratory effort and dynamic lung stress during the first 7 days of spontaneous breathing affect the success or failure of weaning from mechanical ventilation. The study is prospective and observational, conducted in intensive care units from January 2024 to July 2026. Researchers hypothesize that both very low and very high respiratory efforts may be linked to a higher failure rate in weaning and longer periods on mechanical ventilation and hospital stays. Participants are observed in two groups based on their respiratory effort levels: those with low respiratory effort and those with high respiratory effort, defined by specific pressure thresholds (P0.1 and Pocc). No experimental treatments are administered; instead, the study monitors these patients during their first 7 days of spontaneous ventilation after intubation. The research includes evaluation of respiratory effort using measurements such as electrical impedance tomography and diaphragmatic ultrasound. During the study, patients undergo regular assessments that include respiratory effort measurements, lung stress evaluations, and diaphragm function tests. Researchers will analyze outcomes such as weaning failure rates, total weaning time, time on mechanical ventilation, rates and timing of tracheostomy, length of ICU and hospital stay, and in-hospital mortality. Data will be collected and analyzed statistically to explore associations between respiratory effort extremes and clinical outcomes over the course of 2 years from enrollment.
CONDITIONS
Brief Title
Extremes of Respiratory Effort in Weaning Failure From Mechanical Ventilation: a Prospective Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Admitted to the Glória D'or hospital
- Undergoing orotracheal intubation and invasive mechanical ventilation
- In their first 7 days on spontaneous ventilation
- Provide informed consent (or legal representative consent) to participate
You will not qualify if you...
- Neuromuscular disease
- Phrenic nerve injury
- Mechanical ventilation for less than 24 hours
- Previously tracheostomized patient
- Age under 18
- Use of neuromuscular blockers for more than 72 hours
- Chronic obstructive pulmonary disease (COPD)
- Pulmonary fibrosis
- Pregnancy
- Patient under palliative care
- COVID-19 pneumonia
- Patients reintubated after extubation in this hospitalization for less than 3 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants undergoing mechanical ventilation are observed during their first 7 days of spontaneous ventilation to evaluate respiratory effort levels and related outcomes.
Daily assessments during the 7-day spontaneous ventilation period
Duration - Up to 2 years
Participants are followed for up to 2 years to assess weaning success, time on mechanical ventilation, ICU and hospital stay lengths, and survival outcomes.
Periodic follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Gloria D'or hospital
Rio de Janeiro, Brazil, 22211230
Actively Recruiting
Research Team
A
Amanda Pereira da cruz
P
Pedro Leme Silva
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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