Esophageal Manometry in Mechanically Ventilated Patients

Acute Respiratory Failure Clinical Trial

Official title:

Esophageal Manometry in Mechanically Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901158
• Other study ID #: LUA-74203
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

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