Esophageal Pressure Measurements During One-lung Ventilation

NCT04725318 | Terminated Results

• 1 other identifier: 2020P-000811
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery; One-lung Ventilation

Keywords

One-lung ventilation; Electrical Impedance Tomography; Thoracic Surgery; Esophageal manometry; Transpulmonary Pressure; Lung-protective ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Esophageal Pressure

  During one-lung ventilation

• Esophageal Pressure

  During two-lung ventilation in the lateral position

• Esophageal Pressure

  During two-lung ventilation in the supine position

• Optimum PEEP

  During one-lung ventilation

Interventions

One-lung ventilation OTHER

One-lung ventilation as part of routine clinical care for patients undergoing thoracic surgery under general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• adult patients undergoing non-cardiac surgery with OLV

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

One-Lung Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics

Limitations and Caveats

This study was closed due to lack of enrollment. Targeted sample size was not reached.

Results Point of Contact

• Title: Maximilian Schaefer, MD
• Organization: Beth Israel Deaconess Medical Center

msschaef@bidmc.harvard.edu

617-632-7034

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 26, 2021
• Study Start: November 19, 2020
• Primary Completion: February 24, 2021
• Study Completion: December 31, 2021
• Last Updated: February 19, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)