NCT06391424 Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU)
| NCT ID | NCT06391424 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Critical Illness |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-01-01 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In patients who are mechanically ventilated for more than 72 hours weaning failure is a common issue. The Spontaneous breathing trial (SBT) is often done to assess if the patient can be extubated with a high chance of success. However, re-intubation rates are between 15 - 20 % after a successful SBT. The rapid shallow breathing index (RSBI) is an important parameter used in an SBT. Because the high incidence of extubation failure (re-intubation within 48 hours) a search for a better parameter than the RSBI is warranted. Using the measured end-tidal oxygen (etO2) of mechanically ventilated patients it is possible to calculate the VO2, which is a measure of patient effort. The VO2 is a parameter with the potential to predict weaning success or failure, together with other parameters of patient effort like the work of breathing (WOB), pressure time product (PTP) and esophageal pressure swings, reflecting muscle strength of the diaphragm. Therefore, the investigators want to investigate if these parameters are associated with an SBT success or failure.
Eligibility 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
Contact & Investigator
Abraham Schoe, MD PhD
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT06391424 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06391424 currently recruiting?
Yes, NCT06391424 is actively recruiting participants. Contact the research team at f.e.smits@lumc.nl for enrollment information.
Where is the NCT06391424 trial being conducted?
This trial is being conducted at Leiden, Netherlands, Leiden, Netherlands.
Who is sponsoring the NCT06391424 clinical trial?
NCT06391424 is sponsored by Leiden University Medical Center. The principal investigator is Abraham Schoe, MD PhD at Leiden University Medical Center. The trial plans to enroll 60 participants.