Clinical Trials Directory

Trials / Completed

CompletedNCT02446938

Position of Esophageal Balloon in Patients With Mechanical Ventilation

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

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Capital Medical University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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 The catheter is usually inserted into the stomach first, and then slowly withdrawn into the esophagus after inflation of the balloon.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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEsophagus balloon catheter insertion.Esophagus balloon catheter will be inserted and the position of the balloon will be confirmed by a air injection test.A bolus of 30 ml of air was injected to the gastric lumen of the catheter just next to the distal edge of the balloon, during the onset of end-expiratory phase. The presence of a positive disturbing wave (PDW) in esophageal pressure waveform to this air injection will be the indicator of the right balloon position.

Timeline

Start date
2015-05-01
Primary completion
2015-08-01
Completion
2015-09-01
First posted
2015-05-18
Last updated
2015-10-12

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02446938. Inclusion in this directory is not an endorsement.