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Completed

NCT Number: NCT02976844

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

positive end-expiratory pressure

Procedure

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

Primary outcomes

  1. The optimal balloon volume at different PEEP

    Time frame: within 3 minutes after esophageal balloon volume changing

    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.

Secondary outcomes

  1. The transpulmonary pressure

    Time frame: within 3 minutes after esophageal balloon volume changing

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2016
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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