Esophageal Pressure Measurements During One-lung Ventilation

Recruiting

• Conditions: Surgery; One-lung Ventilation

• Registration Number: NCT04725318
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

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 Timeline

• Study Start: 2020-11-19
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-26
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States