Esophageal Pressure Measurements During One-lung Ventilation

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: Terminated
• Conditions: Surgery; One-lung Ventilation
• Intervention / Treatment: Other: One-lung ventilation

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: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophageal Pressure at Lung Collapse	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

Outcome Measure	Measure Description	Time Frame
Esophageal Pressure	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	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	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	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

• Sponsor: Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Thoracic Surgery; One-lung ventilation; Esophageal manometry; Electrical Impedance Tomography; Transpulmonary Pressure; Lung-protective ventilation
• Additional Relevant MeSH Terms: Therapeutics; Airway Management; Respiration, Artificial; One-Lung Ventilation
• Other Study ID 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