Position of Esophageal Balloon in Patients With Mechanical Ventilation

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446938
• Other study ID #: KY-2015-CCM-002
• Status: Completed
• Phase: N/A
• First received: May 14, 2015
• Last updated: October 9, 2015
• Start date: May 2015
• Est. completion date: September 2015

Study information

• Verified date: June 2015
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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 The catheter is usually inserted into the stomach first, and then slowly withdrawn into the esophagus after inflation of the balloon.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	ICU, Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Capital Medical University	Beijing Municipal Administration of Hospitals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The agreement of balloon position confirmed by air injection method and confirmed by the bed-side X-ray.		15 min after the balloon position	No