Actively Recruiting

Age: 18Years +
All Genders
ID07109570

Surface Electrical Myography, Oxygen Consumption (VO2), Effort, and Weaning in Mechanically Ventilated ICU Patients: SERA-Effort Study

Led by Leiden University Medical Center · Updated on 2025-11-26

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

L

Leiden University Medical Center

Lead Sponsor

D

Demcon-Macawi

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of surface electromyography (sEMG) derived from the SERA device to measure respiratory muscle activity, oxygen use, and effort in patients in the Intensive Care Unit who are mechanically ventilated. The study aims to find out if these measurements can help predict weaning failure, where patients struggle to stop ventilator support and may need re-intubation shortly after. This observational study focuses on patients undergoing spontaneous breathing trials to assess their readiness for extubation. Participants will be monitored starting 10 minutes before their spontaneous breathing trial (SBT), continuing throughout the trial, and for 10 minutes after it ends. The study collects data from the SERA device, mechanical ventilator, and oxygen consumption monitors, focusing on various effort parameters including diaphragm electrical activity and breathing workload. No treatments or interventions are given, as this is a data collection study. During the study, participants will have measurements taken of diaphragm electrical signals, oxygen use, esophageal pressures, and breathing patterns related to effort and work of breathing. Researchers will observe these measures before, during, and after the SBT. The main outcome is whether these signals are linked to extubation failure within 48 hours. The study imposes minimal burden or risk, as it does not alter standard care and only involves monitoring. Participants remain under usual medical care throughout the study duration.

CONDITIONS

Brief Title

Surface Electrical Myography, Oxygen Consumption, Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Esophageal catheter in place as part of standard care
  • Eligible for a spontaneous breathing trial according to hospital protocol
Not Eligible

You will not qualify if you...

  • Severe cardiac failure NYHA class IV without mechanical support (LVAD or Impella)
  • COPD Gold IV
  • Pregnancy
  • Patients receiving extracorporeal membrane oxygenation (ECMO)

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

Participants undergo measurements using the SERA device and other monitoring equipment before and during the spontaneous breathing trial (SBT).

1 visit during the spontaneous breathing trial

Long-term Monitoring

Duration - 48 hours after extubation

Participants are monitored for extubation failure and respiratory outcomes within 48 hours after extubation.

Observations during routine care

Trial Site Locations

Total: 1 location

1

Leiden University Medical Centre

Leiden, Netherlands, 2300 ZA

Actively Recruiting

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Research Team

A

Abraham Schoe, MD, PhD

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

0

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