Mechanical VentilationNCT05859672
Ventilation and Esophageal Pressure Changes
An observational study of Mechanical Ventilation, run by University of California, Davis at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2022to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective surgical patients
Who may be able to join
- Patients scheduled for elective surgery requiring general anesthesia and endotracheal intubation.
- Age ≥ 18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: A Study of Intraoperative Transpulmonary and Intrathoracic Pressure Changes Associated With Ventilator Management of Tidal Volume and Positive End-expiratory Pressure (PEEP)
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.
- Conditions
- Mechanical Ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start16 Jun 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neal Fleming, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859672
- Sponsor's protocol ID
- 1903822
- Status last verified
- Sep 2025
- First submitted
- 5 May 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Intraoperative Transpulmonary and Intrathoracic Pressure Changes Associated With Ventilator Management of Tidal Volume and Positive End-expiratory Pressure (PEEP)
- ClinicalTrials.gov ID
- NCT05859672
- Acronym / sponsor ID
- 1903822
- Conditions
- Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective surgical patients
Key inclusion criteria (2 listed)
- Patients scheduled for elective surgery requiring general anesthesia and endotracheal intubation.
- Age ≥ 18
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Stroke Volume Variation
Time frame: Intra-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
Related trials for Mechanical Ventilation
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Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
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Impact of Inspiratory Effort and Patient-Ventilator Interaction During the Transition Phase
Mechanically Ventilated Patients, Acute Respiratory Failure (ARF)
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Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
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Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
High Flow Oxygen Therapy, Non Invasive Ventilation (NIV)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Fleming, MD, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrathoracic Pressure (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.