Esophageal Pressure Measurements During One-lung Ventilation

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725318
• Other study ID #: 2020P-000811
• Status: Recruiting
• Start date: November 19, 2020
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Maximilian S Schaefer, MD
• Phone: 317 306 3216
• Email: msschaef[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• One-lung Ventilation
• Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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