Actively Recruiting

Age: 18Years +
All Genders
ID06464224

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

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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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Long-term Monitoring

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

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Gloria D'or hospital

Rio de Janeiro, Brazil, 22211230

Actively Recruiting

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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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