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

NCT07109570 | Recruiting

• 2 other identifiers: P24.116NL86876.058.24
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to measure effort using esophageal pressure measurements, oxygen consumption and diaphragm activity in mechanically ventilated Intensive Care Unit patients during a Spontaneous Breathing Trial. The main question aims to answer whether the sEMG signal derived from the SERA device, effort parameters and oxygen consumption have an association with weaning failure. Participants will be measured while performing a spontaneous breathing trial.

Conditions

Critical Illness; Intensive Care Units (ICUs); Weaning Failure; Mechanical Ventilation; Spontaneous Breathing Trial; Diaphragm Electrical Activity; Oxygen Consumption

Outcome Measures

Primary Outcomes (2)

• Extubation failure

  Extubation failure is defined by the need for reintubation or death.

  48 hours after extubation

• sEMG differences during SBT

  The AUC of the voltage signal, the phasic level (difference between tonic level and maximum level) and the tonic level (base level).

  10 minutes before switch from support to no support ventilation, the whole duration of the SBT, and the 10 minutes after the SBT when there is again support.

Secondary Outcomes (5)

• Differences of oxygen consumption during SBT

  10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

• Differences of esophageal pressure swings measured with an esophageal catheter during SBT

  10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

• Differences of work of breathing measured with an esophageal catheter during SBT

  10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

• Differences of pressure-time product measured with an esophageal catheter during SBT

  10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

• Differences of rapid shallow breathing index during SBT

  10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The intended population consists of adults who are mechanically ventilated in the ICU and meet the criteria for a regular spontaneous breathing trial according to the ruling LUMC protocol.

You may qualify if:

• years of age or older
• Esophageal catheter in situ (standard of care)
• Eligible for an SBT in the near future according to the LUMC SBT protocol currently valid

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Demcon-Macawi: collaborator

Study Sites (1)

Leiden University Medical Centre

Leiden, 2300 ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Abraham Schoe, MD, PhD

CONTACT

+31715265018; a.schoe@lumc.nl

Florence E Smits, MSc

CONTACT

f.e.smits@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

NL (1)