Observing respiratory effort in patients weaning off mechanical ventilation

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

This study looks at how different levels of breathing effort affect the success of getting patients off mechanical ventilation in the ICU.

Quick facts

• Study type: Observational
• Enrollment: 1 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universidade Federal do Rio de Janeiro (Academic / other)
• Locations: 1 site (Rio de Janeiro)
• Trial ID: NCT06464224 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the failure rate of weaning patients from invasive mechanical ventilation (IMV) and its relationship with extremes of respiratory effort during the first week of spontaneous ventilation. It will analyze various physiological parameters, including dynamic lung stress and diaphragmatic function, to understand how these factors influence weaning outcomes. Conducted in the ICUs of Glória D'or and Niteroi D'or hospitals, the study will include patients over 18 years old who are undergoing orotracheal intubation and IMV. The findings could provide insights into optimizing weaning strategies and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who are undergoing orotracheal intubation and invasive mechanical ventilation within their first 7 days of spontaneous ventilation.

Not a fit: Patients with neuromuscular diseases, phrenic nerve injuries, or those who have been on mechanical ventilation for less than 24 hours will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for weaning patients off mechanical ventilation, potentially reducing ICU stay and improving survival rates.

How similar studies have performed: While this approach is observational, similar studies have indicated that understanding respiratory effort can significantly impact weaning success, suggesting potential for meaningful insights.

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.

Where this trial is running

Rio de Janeiro

• Gloria D'or hospital — Rio de Janeiro, Brazil (Recruiting)

Study contacts

• Study coordinator: Amanda Pereira da cruz

Conditions Mechanical Ventilation Pressure High; Weaning Failure; respiratory drive; respiratory effort