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Esophageal Pressure Measurements During One-lung Ventilation

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ClinicalTrials.gov Identifier: NCT04725318
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
Maximilian S Schaefer, Beth Israel Deaconess Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
Surgery One-lung Ventilation 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 Design
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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Determine Feasibility and Validity of Esophageal and Transpulmonary Pressure Measurements During One Lung Ventilation
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023
Groups and Cohorts
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Intervention Details:
  • Other: One-lung ventilation
    One-lung ventilation as part of routine clinical care for patients undergoing thoracic surgery under general anesthesia

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725318


Contacts
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Contact: Maximilian S Schaefer, MD 317 306 3216 msschaef@bidmc.harvard.edu
Contact: Elias Baedorf-Kassis, MD enbaedor@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Maximilian S Schaefer, MD    617-632-0728    msschaef@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Maximilian S Schaefer, Assistant Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04725318    
Other Study ID Numbers: 2020P-000811
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 4, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Maximilian S Schaefer, Beth Israel Deaconess Medical Center:
One-lung ventilation
Electrical Impedance Tomography
Thoracic Surgery
 Esophageal manometry
Transpulmonary Pressure
Lung-protective ventilation