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
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 14, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 12, 2015
June 1, 2015
3 months
May 14, 2015
October 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The agreement of balloon position confirmed by air injection method and confirmed by the bed-side X-ray.
15 min after the balloon position
Interventions
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.
Eligibility Criteria
Adult patients with mechanical ventilation.
You may qualify if:
- adult patients receiving invasive mechanical ventilation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Related Publications (1)
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.
PMID: 28936952DERIVED
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 14, 2015
First Posted
May 18, 2015
Study Start
May 1, 2015
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
October 12, 2015
Record last verified: 2015-06