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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02901158
Other study ID # LUA-74203
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date May 2018

Study information

Verified date October 2018
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure.

In this study high resolution solid-state manometry technique was used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure.


Description:

Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure.

In this study high resolution solid-state manometry technique was instead used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. The manometry catheter has 36 circumferential sensors at 1 cm intervals. Each sensor has 12 pressure-sensitive segments that add to the signal at that location. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure. Possible differences in tidal variations in esophageal pressure in different parts of the esophagus were assessed.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients in the critical care unit receiving mechanical ventilation or Patients anesthetized and undergoing surgery

Exclusion Criteria:

- Patients with a contraindication to insert a catheter in the esophagus for instance due to an operation.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Esophageal pressure measurements in mechanically ventilated patients Esophageal pressure was measured in mechanically ventilated patients in the critical care unit and in the operating room. Within one hour
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