NCT06584604 Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation
| NCT ID | NCT06584604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Intensive Care Unit |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-29 |
| Primary Completion | 2026-10 |
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 40 participants in total. It began in 2024-12-29 with a primary completion date of 2026-10.
⚠ 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
Calibration of the esophageal balloon catheter (Pes catheter) is important for the right measurement of the esophageal pressure (Pes) and subsequent interpretation of the derived transpulmonary pressures during mechanical ventilation. Both relative changes and absolute values of Pes can be affected by inappropriate filling of the esophageal balloon and by the elastance of the esophagus wall. Therefore one should calibrate the balloon to determine the best filling pressure. Calibration of the Pes catheter has only been validated in mandatory ventilation but not in support modes in which the patient triggers the ventilator and is supported by the mechanical ventilator. Because the forces in the thoracic cage behave differently in comparison with a controlled mode, it is to be expected that the calibration process in a support mode yields different filling volumes in comparison with the calibration process in a controlled mode. This would lead to a more reliable filling volume in support mechanical ventilation and a more reliable derivation of transpulmonary pressure and therefore to a better treatment of patients.
Eligibility Criteria
Inclusion Criteria: * 18 years or older. * Mechanically ventilated in spontaneous mode. * Sedated (Richmond Agitation Sedation Scale (RASS) between -3 and -5). * Pes catheter in situ according to the protocol used in the LUMC (Insertion of a Pes catheter is mandatory if it is suspected that te patient will be ventilated for more than 24 hrs.). Exclusion Criteria: * Medical condition that excludes the placement of a Pes catheter. * Allergic reaction against rocuronium in the past. * Pregnant. * RASS \> -3
Contact & Investigator
Abraham Schoe, MD, PhD
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT06584604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intensive Care Unit. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06584604 currently recruiting?
Yes, NCT06584604 is actively recruiting participants. Contact the research team at j.w.m.snoep@lumc.nl for enrollment information.
Where is the NCT06584604 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT06584604 clinical trial?
NCT06584604 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 40 participants.