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

NCT ID: NCT02976844

Last Updated: 2017-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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

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Mechanical Ventilation

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Low PEEP group

The positive end-expiratory pressure was less than 10cmH2O

Positive end-expiratory Pressure

Intervention Type PROCEDURE

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

High PEEP group

The positive end-expiratory pressure was higher or equal to 10cmH2O.

Positive end-expiratory Pressure

Intervention Type PROCEDURE

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

Interventions

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Positive end-expiratory Pressure

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jian-Xin Zhou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian-Xin Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Sun XM, Chen GQ, Huang HW, He X, Yang YL, Shi ZH, Xu M, Zhou JX. Use of esophageal balloon pressure-volume curve analysis to determine esophageal wall elastance and calibrate raw esophageal pressure: a bench experiment and clinical study. BMC Anesthesiol. 2018 Feb 14;18(1):21. doi: 10.1186/s12871-018-0488-6.

Reference Type DERIVED
PMID: 29444644 (View on PubMed)

Other Identifiers

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KY-2016-11-22

Identifier Type: -

Identifier Source: org_study_id

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