Clinical trial NCT02446938: Position of Esophageal Balloon in Patients With Mechanical Ventilation
Official title: A Simple Method for Confirming the Optimal Position of Esophageal Balloon in Patients With Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Keywords: mechanical ventilation
esophageal pressure
catheter position
validation
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Administration of Hospitals
First posted: 2015-05-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with mechanical ventilation.

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 The catheter is usually inserted into the stomach first, and then slowly withdrawn into the esophagus after inflation of the balloon.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

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

Primary outcomes:
measure: The agreement of balloon position confirmed by air injection method and confirmed by the bed-side X-ray.
timeFrame: 15 min after the balloon position
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: ICU, Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References:
citation: 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.