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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02976844
Enrollment
12
Registered
2016-11-29
Start date
2016-08-31
Completion date
2017-01-31
Last updated
2017-08-07

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

Conditions

Mechanical Ventilation

Keywords

optimal balloon volume, positive end-expiratory pressure

Brief 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.

Interventions

PROCEDUREPositive end-expiratory Pressure

Positive end-expiratory pressure will be used during mechanical ventilation.

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The optimal balloon volume at different PEEPwithin 3 minutes after esophageal balloon volume changingThe 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.

Secondary

MeasureTime frame
The transpulmonary pressurewithin 3 minutes after esophageal balloon volume changing

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026