Ventilation and Esophageal Pressure Changes

NCT ID: NCT05859672

Last Updated: 2025-09-18

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

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-16

Study Completion Date

2024-07-01

Brief Summary

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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

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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.

Conditions

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Mechanical Ventilation

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for elective surgery requiring general anesthesia and endotracheal intubation.
* Age ≥ 18

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal Fleming, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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UC Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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1903822

Identifier Type: -

Identifier Source: org_study_id

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