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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Extubation failure

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

Time frame
48 hours after extubation
2

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).

Time frame
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

1

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.

Time frame
10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
2

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.

Time frame
10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
3

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.

Time frame
10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
4

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.

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

Other outcomes

Sponsors and contacts

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