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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02446938
Enrollment
20
Registered
2015-05-18
Start date
2015-05-31
Completion date
2015-09-30
Last updated
2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation

Keywords

mechanical ventilation, esophageal pressure, catheter position, validation

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 The catheter is usually inserted into the stomach first, and then slowly withdrawn into the esophagus after inflation of the balloon.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

Interventions

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.

Sponsors

Beijing Municipal Administration of Hospitals
CollaboratorOTHER_GOV
Capital Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The agreement of balloon position confirmed by air injection method and confirmed by the bed-side X-ray.15 min after the balloon position

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026