Actively Recruiting

Age: 18Years +
All Genders
ID06391424

Oxygen Consumption (VO2), Effort, and Weaning in Mechanically Ventilated ICU Patients: EXTUBATE Study

Led by Leiden University Medical Center · Updated on 2024-09-19

60

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Weaning failure is a common challenge for patients who have been on mechanical ventilation for more than 72 hours, leading to complications if extubation timing is not optimal. This observational study explores better ways to predict successful extubation by investigating oxygen consumption (VO2) and other measures of patient effort during spontaneous breathing trials (SBT). Researchers aim to identify parameters that could improve predictions of weaning success or failure, potentially reducing re-intubation rates. Participants will undergo a spontaneous breathing trial according to the Leiden University Medical Center protocol, with measurements taken of oxygen consumption using end-tidal oxygen levels, as well as work of breathing, pressure time product, and esophageal pressure swings through an esophageal catheter. These parameters will be monitored before, during, and after the SBT to assess their association with extubation outcomes. During the study, patients' breathing efforts and oxygen use will be carefully measured at specific time points around the SBT. The primary focus is on the incidence of weaning failure within 48 hours after the SBT and changes in oxygen consumption throughout the trial. Secondary assessments include changes in esophageal pressure swings, work of breathing, pressure time product, and the rapid shallow breathing index. The study involves close monitoring in the intensive care unit environment, with data collected to enhance understanding of predictors for successful weaning from mechanical ventilation.

CONDITIONS

Brief Title

Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age above 18 years
  • Mechanically ventilated for more than 24 hours
  • Eligible for a spontaneous breathing trial according to the clinical team
  • Undergoing regular spontaneous breathing trial as per Leiden University Medical Center protocol
  • Hemodynamically stable
  • Presence of an esophageal catheter
Not Eligible

You will not qualify if you...

  • Severe chronic obstructive pulmonary disease (COPD) classified as Gold class IV causing non-regular spontaneous breathing trial
  • Heart failure with left ventricular ejection fraction below 30% causing non-regular spontaneous breathing trial
  • Known pregnancy

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)

Diagnostic Evaluation

Duration - Approximately 50 minutes including 10 minutes before, 30 minutes during, and 10 minutes after the SBT

Participants undergo a spontaneous breathing trial (SBT) which includes measurements of oxygen consumption and patient effort to assess readiness for extubation.

1 visit (in-person)

Long-term Monitoring

Duration - 48 hours

Participants are observed for 48 hours after the spontaneous breathing trial to track incidence of weaning failure and extubation outcomes.

Observation period with no additional visits required

Trial Site Locations

Total: 2 locations

1

Leiden University Medical Centre

Leiden, South Holland, Netherlands, 2333 ZA

Actively Recruiting

2

Leiden University Medical Center

Leiden, Netherlands, 2333ZA

Not Yet Recruiting

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Research Team

F

Florence E Smits, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

The impact of intermittent exercise in a hypoxic environment on redox status and cardiac troponin release in the serum of well-trained marathon runners.

Feifei Li, Jinlei Nie, Yifan Lu...

https://pubmed.ncbi.nlm.nih.gov/27572505

Increase of oxygen consumption during a progressive decrease of ventilatory support is lower in patients failing the trial in comparison with those who succeed.

Giacomo Bellani, Giuseppe Foti, Ester Spagnolli...

https://pubmed.ncbi.nlm.nih.gov/20613464

P0.1 is an Unreliable Measure of Effort in Support Mechanical Ventilation in Comparison With Esophageal-Derived Measures of Effort: A Comparison Study.

Florence E Smits, Petra J Rietveld, Jacob W M Snoep...

https://pubmed.ncbi.nlm.nih.gov/40638487