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CompletedNCT05859672Updated Sep 18, 2025

Ventilation and Esophageal Pressure Changes

An observational study in Mechanical Ventilation, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by University of California, Davis · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mechanical Ventilation
03

In context

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Elective surgical patients

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Intrathoracic Pressure

    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

    Time frame: Intra-operative

Secondary outcomes

  1. Stroke Volume Variation

    Characterizing the changes in SVV associated with intraoperative changes in mechanical ventilation parameters such as tidal volume and PEEP and the correlations with changes in intrathoracic pressure.

    Time frame: Intra-operative

07

Study locations

1 site
  • UC Davis Medical Center
    Sacramento, California 95817, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05859672
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
May 16, 2023
Start date
Jun 16, 2022
Primary completion
Jul 1, 2024
Completion
Jul 1, 2024
Last update
Sep 18, 2025

Study contacts

Neal Fleming, MD, PhD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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