Effect of Positive End-expiratory Pressure on Optimal Balloon Volume During Esophageal Pressure Monitoring

Mechanical Ventilation Clinical Trial

Official title:

Effect of Positive End-expiratory Pressure on Optimal Balloon Volume During Esophageal Pressure Monitoring in Mechanical Ventilated Patients: A Clinical Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976844
• Other study ID #: KY-2016-11-22
• Status: Completed
• Phase: N/A
• First received: November 23, 2016
• Last updated: August 3, 2017
• Start date: August 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Esophageal pressure (PES), which has been used as a surrogate for pleural pressure. The volume of esophageal balloon can influence the accuracy of monitoring esophageal pressure. The optimal balloon volume is directly dependent on surrounding pressure. In the present study,the investigators will observe the optimal volume of esophageal balloon during the different PEEP in bench and clinical study.

Description:

The esophageal pressure (Pes) is used as a surrogate for pleural pressure to obtain transpulmonary pressure. Catheter with air balloon is the most commonly used method to measure the Pes. The optimal injected volume of the balloon is the key factor in accurate measurement of Pes. The recoil pressure of the balloon turns up while the balloon is over-filled, resulting in over-estimation of the PES; on the other hand, an under-filled balloon also cannot properly transmit the surrounding pressure of balloon. However, the researchers showed the optimal balloon volumes is related to the surrounding pressure and even is not correspond with manufacturer's recommendations. Theoretically, when balloon transmural pressure(PTM) is zero, representing the balloon in a condition with equivalent pressure inside and outside of the balloon, it was defined as optimal volume. However, in clinical settings, it is difficult to determine the balloon PTM, and therefore the optimal volume cannot be obtained, because the surrounding pressure of the balloon cannot be conveniently measured.

In the present study, the investigators will develop a simple method to obtain the optimal balloon volume and observe the effect of positive end-expiratory pressure on optimal balloon volume during esophageal pressure monitoring. The investigators want to validate the accuracy of method in the bench study and clinical feasibility in mechanical ventilated patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• postoperative patients with delayed emergence from general anesthesia admitted to the ICU for mechanical ventilation.

Exclusion Criteria:

• age under 18 years;

• diagnosed or suspected esophageal varices;

• history of chronic obstructive pulmonary diseases or asthma;

• history of esophageal, gastric or lung surgery;

• evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or an existing chest tube;

• evidence of severe coagulopathy.

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Procedure:
• Positive end-expiratory Pressure
Positive end-expiratory pressure will be used during mechanical ventilation.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The optimal balloon volume at different PEEP	The 3 minutes after esophageal balloon volume changing, the investigators will record the end-expiratory and end-inspiratory esophageal pressure. The pressure and volume curve will be drawn to determine the optimal volume.	within 3 minutes after esophageal balloon volume changing
Secondary	The transpulmonary pressure		within 3 minutes after esophageal balloon volume changing