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Clinical Trials/NCT05859672
NCT05859672
Completed
Not Applicable

A Study of Intraoperative Transpulmonary and Intrathoracic Pressure Changes Associated With Ventilator Management of Tidal Volume and Positive End-expiratory Pressure (PEEP)

University of California, Davis1 site in 1 country150 target enrollmentJune 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation
Sponsor
University of California, Davis
Enrollment
150
Locations
1
Primary Endpoint
Intrathoracic Pressure
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

A study to observe the effect of variations in ventilator settings including tidal volume and PEEP on transpulmonary pressure monitored with an esophageal balloon catheter and to correlate intraoperative transpulmonary pressure variations and intraoperative stroke volume variation changes.

Detailed Description

This study seeks to observe the effects of variations in ventilator settings on transpulmonary and intrathoracic pressures. More specifically, to observe the impact of variations in tidal volume from 6 mL/kg to 8 mL/kg and PEEP from 0 cm of water (H2O) to 5 cm H2O on transpulmonary and intrathoracic pressures monitored with an esophageal balloon catheter. The impact of this recommended decrease in tidal volume on the clinical utility of stroke volume variation (SVV) as a guide for fluid administration has not been previously examined.

Registry
clinicaltrials.gov
Start Date
June 16, 2022
End Date
July 1, 2024
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for elective surgery requiring general anesthesia and endotracheal intubation.

Exclusion Criteria

  • Patients undergoing planned esophageal surgery
  • Patients with significant nasal or esophageal pathology
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Outcomes

Primary Outcomes

Intrathoracic Pressure

Time Frame: Intra-operative

Measure the intrathoracic pressure changes monitored with an esophageal pressure balloon catheter associated with intraoperative changes in mechanical ventilation parameters such as tidal volume and PEEP

Secondary Outcomes

  • Stroke Volume Variation(Intra-operative)

Study Sites (1)

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