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Position of Esophageal Balloon in Patients With Mechanical Ventilation

Information source: Capital Medical University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mechanical Ventilation

Intervention: Esophagus balloon catheter insertion. (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Capital Medical University

Overall contact:
Jian-Xin Zhou, MD, Phone: 8610 67098019, Email: zhoujx.cn@gmail.com

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.

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

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

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 The catheter is usually inserted into the stomach first, and then slowly withdrawn into the esophagus after inflation of the balloon.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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Jian-Xin Zhou, MD, Phone: 8610 67098019, Email: zhoujx.cn@gmail.com

ICU, Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing 100050, China; Recruiting
Jian-Xin Zhou, MD, Phone: 8610 67096579, Email: zhoujx.cn@gmail.com
Additional Information

Starting date: May 2015
Last updated: June 12, 2015

Page last updated: August 20, 2015

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