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

NCT02976844 | Completed DMC

• 1 other identifier: KY-2016-11-22
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation

Keywords

optimal balloon volume; positive end-expiratory pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The transpulmonary pressure

  within 3 minutes after esophageal balloon volume changing

Study Arms (2)

Low PEEP group

The positive end-expiratory pressure was less than 10cmH2O

Procedure: Positive end-expiratory Pressure

High PEEP group

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

Procedure: Positive end-expiratory Pressure

Interventions

Positive end-expiratory Pressure PROCEDURE

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

High PEEP group; Low PEEP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

postoperative patients receiving mechanical ventilation

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

• 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.

  PMID: 29444644 DERIVED

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Jian-Xin Zhou, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 29, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 7, 2017

Record last verified: 2017-01

Locations

CN (1)