Esophageal Pressure Measurements During One-lung Ventilation

February 3, 2026 updated by: Maximilian S Schaefer, Beth Israel Deaconess Medical Center

An Observational Study to Determine Feasibility and Validity of Esophageal and Transpulmonary Pressure Measurements During One Lung Ventilation

The investigators will assess the feasibility and validity of esophageal pressure measurements during one-lung ventilation in the lateral position for surgery by comparing to lung collapse estimated from electrical impedance tomography during a PEEP trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this prospective cohort study, the investigators will assess the feasibility of esophageal pressure measurements during general anesthesia with one-lung ventilation in patients undergoing non-cardiac intrathoracic surgery, which is typically conducted in the lateral position. The investigators will measure esophageal pressure with an esophageal balloon catheter. The investigators will compare esophageal pressure measurements to lung collapse estimated by Electrical Impedance Tomography (EIT).

Patients will be equipped with the EIT belt before induction of anesthesia, and a one-minute EIT recording during spontaneous breathing will be conducted. Anesthesia will be induced as to institutional standards and upon the discretion of the attending anesthesiologist. After placement of a double-lumen endotracheal tube, the esophageal balloon catheter will be placed.

  • After placement of the esophageal catheter, esophageal pressure, transpulmonary pressure, airway pressure and flow and EIT signal will be recorded ("baseline").
  • When the patient has been positioned for surgery (typically in the lateral position), a second recording of the above parameters is conducted ("lateral"). One-lung ventilation will then be initiated and a third measurement ("OLV") is made.
  • During the third measurement, a decremental positive end-expiratory pressure trial will be conducted to correlate the measured esophageal pressure to the positive end-expiratory pressure where lung collapse is detected from EIT.
  • Before surgery, the EIT belt is opened and removed from the surgical field to avoid interference.
  • If feasible, when surgery is finished, before reversal of neuromuscular blockade and extubation, a final recording of EIT, esophageal pressure, transpulmonary pressure, airway pressure and flow will be conducted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing non-cardiac surgery requiring one-lung ventilation under general anesthesia as part of clinical routine

Description

Inclusion Criteria:

  • adult patients undergoing non-cardiac surgery with OLV

Exclusion Criteria:

  • COPD
  • Active respiratory infection
  • Prior lung resection
  • Prior esophageal/gastric surgery
  • Esophageal varices
  • Patients under effective anticoagulation at time of surgery
  • Pacemaker/ICD
  • Pregnancy
  • Inability to give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Esophageal Pressure at Lung Collapse
Time Frame: During one-lung ventilation
Esophageal pressure during one-lung ventilation in the lateral position at beginning lung collapse as measured by electrical impedance tomography during a decremental PEEP titration
During one-lung ventilation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Esophageal Pressure
Time Frame: During one-lung ventilation
Esophageal Pressure during one-lung ventilation in the lateral position at airway closure as assessed by pressure-volume curves
During one-lung ventilation
Esophageal Pressure
Time Frame: During two-lung ventilation in the lateral position
Esophageal Pressure during two-lung ventilation in the lateral position at airway closure as assessed by pressure-volume curves
During two-lung ventilation in the lateral position
Esophageal Pressure
Time Frame: During two-lung ventilation in the supine position
Esophageal Pressure during two-lung ventilation in the supine position at airway closure as assessed by pressure-volume curves
During two-lung ventilation in the supine position
Optimum PEEP
Time Frame: During one-lung ventilation
PEEP during PEEP titration that provides optimum trade-off between lung collapse and overdistension, as measured by Electrical Impedance Tomography
During one-lung ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020P-000811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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