Position of Esophageal Balloon in Patients With Mechanical Ventilation

NCT ID: NCT02446938

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-09-30

Brief Summary

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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

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 The catheter is usually inserted into the stomach first, and then slowly withdrawn into the esophagus after inflation of the balloon.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

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Mechanical Ventilation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Esophagus 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Municipal Administration of Hospitals

OTHER_GOV

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jian-Xin Zhou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Chen H, Xu M, Yang Y, He X, Zhou J. [Application of injection test in confirming the ideal position of esophageal balloon catheter]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2017 Sep;29(9):783-788. doi: 10.3760/cma.j.issn.2095-4352.2017.09.004. Chinese.

Reference Type DERIVED
PMID: 28936952 (View on PubMed)

Other Identifiers

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KY-2015-CCM-002

Identifier Type: -

Identifier Source: org_study_id

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