About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Severe cardiac failure NYHA class IV without mechanical support (LVAD or Impella)
COPD Gold IV
Pregnancy
Patients with ECMO
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Extubation failure
Extubation failure is defined by the need for reintubation or death.
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).
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Leiden University Medical Center
Lead sponsor
Demcon-Macawi
Collaborator