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Clinical Trials/NCT02446938
NCT02446938
Completed
Not Applicable

A Simple Method for Confirming the Optimal Position of Esophageal Balloon in Patients With Mechanical Ventilation

Capital Medical University1 site in 1 country20 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation
Sponsor
Capital Medical University
Enrollment
20
Locations
1
Primary Endpoint
The agreement of balloon position confirmed by air injection method and confirmed by the bed-side X-ray.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Transpulmonary pressure is frequently monitored in patients with mechanical ventilation. Right position of the catheter balloon is the key factor in accurate measurement. A simple method for confirming the balloon position will be validate in this study.

Detailed Description

Transpulmonary pressure, which is the pressure at the airway opening minus pleural pressure, is frequently monitored in patients with mechanical ventilation. Because pleural pressure is difficult to measure in most clinical situations, esophageal pressure (Pes) is used as a surrogate. Catheter with air balloon is the most commonly used method to measure the Pes. Right position of the balloon is the key factor in accurate measurement of Pes, and the lower third part of esophagus is recommended as the target position of the balloon. The catheter is usually inserted into the stomach first, and then slowly withdrawn into the esophagus after inflation of the balloon. A negative pressure deflection replacing the positive pressure deflection during inspiration generally indicates the balloon's entering into the esophagus. This confirmation method depends on the normal function of diaphragm. However, it may not always be possible to obtain the standard pressure deflections in patients with mechanical ventilation, especially in those with diaphragmatic paralysis. In present study, the investigators developed a simple method to confirm the balloon position by using a modified SmartcathG esophageal balloon catheter. The objective was to evaluate the validity of this method and to investigate the relationship between the cardiac artifacts of the Pes tracings and the position of the balloon.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
September 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Capital Medical University
Responsible Party
Principal Investigator
Principal Investigator

Jian-Xin Zhou

Professor

Capital Medical University

Eligibility Criteria

Inclusion Criteria

  • adult patients receiving invasive mechanical ventilation

Exclusion Criteria

  • age under 18 years old
  • esophageal varices
  • evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube
  • history of chronic obstructive pulmonary disease
  • history of lung surgery
  • pregnancy
  • severe coagulopathy

Outcomes

Primary Outcomes

The agreement of balloon position confirmed by air injection method and confirmed by the bed-side X-ray.

Time Frame: 15 min after the balloon position

Study Sites (1)

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