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Clinical Trial NCT07109570 (SERA-Effort) for Critical Illness, Intensive Care Units (ICUs), Weaning Failure, Mechanical Ventilation, Spontaneous Breathing Trial, Diaphragm Electrical Activity, Oxygen Consumption is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Surface Electrical Myography, Oxygen Consumption, Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (SERA-Effort) 60 Observational

Recruiting
Clinical Trial NCT07109570 (SERA-Effort) is an observational study for Critical Illness, Intensive Care Units (ICUs), Weaning Failure, Mechanical Ventilation, Spontaneous Breathing Trial, Diaphragm Electrical Activity, Oxygen Consumption that is recruiting. It started on 8 July 2025 with plans to enroll 60 participants. Led by Leiden University Medical Center, it is expected to complete by 1 June 2029. The latest data from ClinicalTrials.gov was last updated on 26 November 2025.
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 wi...

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Detailed Description
Rationale: In patients mechanically ventilated for more than 72 hours weaning from the ventilator and successful extubation can be problematic. The spontaneous breathing trial (SBT) is a tool to predict successful extubation. However re-intubation withing 48 hours occurs in 15-20% of the patients after a successful SBT. The key parameter of the SBT is the rapid shallow breathing index (RSBI). Since the rate of extuba...Show More
Official Title

Surface Electrical Myography, Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU): SERA-Effort Study

Conditions
Critical IllnessIntensive Care Units (ICUs)Weaning FailureMechanical VentilationSpontaneous Breathing TrialDiaphragm Electrical ActivityOxygen Consumption
Other Study IDs
  • SERA-Effort
  • P24.116
  • NL86876.058.24 (Other Identifier) (ToetsingOnline)
NCT ID Number
NCT07109570
Start Date (Actual)
2025-07-08
Last Update Posted
2025-11-26
Completion Date (Estimated)
2029-06
Enrollment (Estimated)
60
Study Type
Observational
Status
Recruiting
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Differences of oxygen consumption during SBT
The values of oxygen consumption (in milliliter/minute) and the differences between start, during, and end of the 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
The values of pressure swings (in cmH2O), measured with an esophageal catheter, and the differences between start, during, and end of the 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
The values of work of breathing (in Joules/liter), measured with an esophageal catheter, and the differences between start, during, and end of the 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
The values of pressure-time product (in cmH2O/seconds), measured with an esophageal catheter, and the differences between start, during, and end of the SBT.
10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
Differences of rapid shallow breathing index during SBT
The values of rapid shallow breathing index (breaths/minute/liter) and the differences between start, during, and end of the SBT.
10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 18 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

  • Severe cardiac failure NYHA class IV without mechanical support (LVAD or Impella)
  • COPD Gold IV
  • Pregnancy
  • Patients with ECMO
Leiden University Medical Center logoLeiden University Medical Center
Demcon-Macawi logoDemcon-Macawi
Study Responsible Party
Abraham Schoe, MD, PhD., Principal Investigator, MD, PhD, Leiden University Medical Center
Study Central Contact
Contact: Abraham Schoe, MD, PhD, +31715265018, [email protected]
Contact: Florence E Smits, MSc, [email protected]
1 Study Locations in 1 Countries
Leiden University Medical Centre, Leiden, 2300 ZA, Netherlands
Abraham Schoe, MD, PhD, Contact, 0681174475, [email protected]
Recruiting