Assessing oxygen consumption and weaning success in ICU patients on mechanical ventilation
Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU): EXTUBATE Study
Leiden University Medical Center · NCT06391424
This study is testing if measuring oxygen levels can help doctors better predict when patients on mechanical ventilation in the ICU can safely breathe on their own without needing to be re-intubated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center (other) |
| Locations | 2 sites (Leiden, South Holland and 1 other locations) |
| Trial ID | NCT06391424 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients who have been mechanically ventilated for over 72 hours and aims to improve the prediction of successful extubation. It evaluates the use of end-tidal oxygen measurements to calculate oxygen consumption (VO2) alongside other parameters like work of breathing and pressure time product. By identifying better predictors of weaning success, the study seeks to reduce the high rates of re-intubation and associated complications. The research is conducted at the Leiden University Medical Center following specific protocols for spontaneous breathing trials.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years who have been mechanically ventilated for more than 24 hours and are hemodynamically stable.
Not a fit: Patients with severe chronic obstructive pulmonary disease or significant heart failure that complicates the weaning process may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved extubation strategies, reducing the risk of re-intubation and enhancing patient outcomes in the ICU.
How similar studies have performed: Other studies have explored various parameters for predicting weaning success, but this specific approach using VO2 is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age above 18 years
* \> 24 hours mechanically ventilated
* Eligible for a spontaneous breathing trial according to the clinical team
* Regular SBT ("Regulier SBT") according to the Leiden University Medical Center (LUMC) protocol
* Hemodynamically stable
* Esophageal Catheter in situ
Exclusion Criteria:
* Severe chronic obstructive pulmonary disease (COPD) (Gold class IV) if it results in a non regular SBT according to the LUMC protocol.
* Heart failure (LVEF \<30%) if it results in a non regular SBT according to the LUMC protocol
* Known pregnancy
Where this trial is running
Leiden, South Holland and 1 other locations
- Leiden University Medical Centre — Leiden, South Holland, Netherlands (RECRUITING)
- Leiden University Medical Center — Leiden, Netherlands (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Abraham Schoe, MD PhD — Leiden University Medical Center
- Study coordinator: Florence E Smits, MSc
- Email: f.e.smits@lumc.nl
- Phone: +31 (0)71-5262164
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critical Illness, Intensive Care Unit, Oxygen Consumption, Weaning Failure, Mechanical Ventilation, Spontaneous Breathing Trial