Esophageal Pressure Measurements During One-lung Ventilation

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04725318
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Anticipated Duration (Months): 24.4
• Patients Per Site Per Month: 1

Study Details

Study Description

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	Phase
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

• Study Type: Observational
• Anticipated 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: Nov 19, 2020
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Outcome Measures

Primary Outcome Measures

1. Esophageal pressure at lung collapse [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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jan 26, 2021
• Last Update Posted: Sep 21, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Assistant Professor of Anaesthesia, Beth Israel Deaconess Medical Center: One-lung ventilation; Electrical Impedance Tomography; Thoracic Surgery; Esophageal manometry; Transpulmonary Pressure; Lung-protective ventilation

Study Results

No Results Posted as of Sep 21, 2021