NCT02976844

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Mechanical Ventilation

Interventions

Type	Name	Description
PROCEDURE	Positive end-expiratory Pressure	Positive end-expiratory pressure will be used during mechanical ventilation.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-11-29
• Last updated: 2017-08-07

Locations

1 site across 1 country: China