NCT05859672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

May 5, 2023

Last Update Submit

September 12, 2025

Conditions

Mechanical Ventilation

Outcome Measures

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

    Intra-operative

Secondary Outcomes (1)

  • Stroke Volume Variation

    Intra-operative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elective surgical patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Study Officials

  • Neal Fleming, MD, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 16, 2023

Study Start

June 16, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations

US(1)