Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584604
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation PESCA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PESCA
Brief Summary:
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
Detailed Description:
In mechanical ventilation the esophageal pressure Pes is used to calculate the transpulmonary pressure PL The transpulmonary pressure is used to set the positive end expiratory pressure PEEP and the inspiratory pressure In spontaneous mechanical ventilation the transpulmonary pressure swing which is the difference between the maximum and minimum transpulmonary pressure is used as a measure of patient effort Too much patient effort is perhaps detrimental in patients with early severe ARDS leading to additional lung damage and possibly a prolonged ICU stay
The Pes is measured using a separate or integrated feeding tube and Pes catheter esophageal balloon catheter The catheter is placed in the right position and has to be inflated to produce a readable pressure signal The Pes balloon needs calibration before measurement to be sure that the readings are trustworthy When calibrating one should take the compliance of the esophagus into account together with the calibration curve and with that the filling volume of the patient changes from patient to patient A calibration study of the Pes catheter has only been performed in passive mechanically ventilated patients ie in patients without any breathing efforts
In spontaneous breathing patients who still needs support from the ventilator the forces within the thorax differ considerably in comparison with passive patients When initiating a breath the diaphragm of the patient will move downwards and the Pes will become negative In passive patient the ventilator initiates the breath and the diaphragm will be pushed downwards but the Pes will become more positive It is probable that the calibration methods used in passive patients is not feasible in patients who exhibit a breathing effort It is therefore necessary to study the calibration of the esophageal balloon catheter in patients that breath spontaneously with the support of a mechanical ventilator
The hypothesis is that the calibration method and therefore the filling pressure of the balloon is different from the values when the patient would be ventilated in a passive mode Wrong calibration leads to wrong values which could possibly lead to wrong interpretation of the obtained values with possible harm for the patient
The Pes is measured using a separate or integrated feeding tube and Pes catheter esophageal balloon catheter The catheter is placed in the right position and has to be inflated to produce a readable pressure signal The Pes balloon needs calibration before measurement to be sure that the readings are trustworthy When calibrating one should take the compliance of the esophagus into account together with the calibration curve and with that the filling volume of the patient changes from patient to patient A calibration study of the Pes catheter has only been performed in passive mechanically ventilated patients ie in patients without any breathing efforts
In spontaneous breathing patients who still needs support from the ventilator the forces within the thorax differ considerably in comparison with passive patients When initiating a breath the diaphragm of the patient will move downwards and the Pes will become negative In passive patient the ventilator initiates the breath and the diaphragm will be pushed downwards but the Pes will become more positive It is probable that the calibration methods used in passive patients is not feasible in patients who exhibit a breathing effort It is therefore necessary to study the calibration of the esophageal balloon catheter in patients that breath spontaneously with the support of a mechanical ventilator
The hypothesis is that the calibration method and therefore the filling pressure of the balloon is different from the values when the patient would be ventilated in a passive mode Wrong calibration leads to wrong values which could possibly lead to wrong interpretation of the obtained values with possible harm for the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None