Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation

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

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • There is no intervention

    Other intervention

    There is no intervention

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
45 minutes

Secondary outcomes

1

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.

Time frame
45 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Leiden University Medical Center

Lead sponsor

Hamilton Medical AG

Collaborator