About this trial
Calibration of the esophageal balloon catheter (Pes catheter) is important for the right measurement of the esophageal pressure (Pes) and subsequent interpretation of the derived transpulmonary pressures during mechanical ventilation. Both relative changes and absolute values of Pes can be affected by inappropriate filling of the esophageal balloon and by the elastance of the esophagus wall. Therefore one should calibrate the balloon to determine the best filling pressure. Calibration of the Pes catheter has only been validated in mandatory ventilation but not in support modes in which the patient triggers the ventilator and is supported by the mechanical ventilator. Because the forces in the thoracic cage behave differently in comparison with a controlled mode, it is to be expected that the calibration process in a support mode yields different filling volumes in comparison with the calibration process in a controlled mode. This would lead to a more reliable filling volume in support mechanical ventilation and a more reliable derivation of transpulmonary pressure and therefore to a better treatment of patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older.
Mechanically ventilated in spontaneous mode.
Sedated (Richmond Agitation Sedation Scale (RASS) between -3 and -5).
Pes catheter in situ according to the protocol used in the LUMC (Insertion of a Pes catheter is mandatory if it is suspected that te patient will be ventilated for more than 24 hrs.).
Disqualifiers
Medical condition that excludes the placement of a Pes catheter.
Allergic reaction against rocuronium in the past.
Pregnant.
RASS > -3
Trial population
ICU patients who are on mechanical ventilation with a esophageal balloon catheter in situ according to the current LUMC protocol. Expected mechanical ventilation time \> 24 hrs. RASS between -3 and -5;
Trial design
Cohort
Prospective
Treatments tested in this trial
There is no intervention
Other interventionThere is no intervention
Treatment groups
Trial outcomes
Primary outcomes
Esophageal pressures (in cmH2O) measured by the balloon catheter at different filling volumes (in ml)
To obtain a calibration method for the oesophageal balloon catheter in patients ventilated with a support mode and breathing spontaneously. Two, often used balloon catheters will be tested.
Secondary outcomes
The difference of optimal filling volume in spontaneously breathing and in passive ventilation (in cmH2O)
After measurements of the esophageal balloon were done during spontaneously breathing patients, measurements were done during mandatory ventilation while patient is passive. The measurements are the values and the optimal filling volume of the esophageal balloon in spontaneously breathing and in a passive mode.
Sponsors and contacts
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Leiden University Medical Center
Lead sponsor
Hamilton Medical AG
Collaborator