Clinical trial NCT04725318: Esophageal Pressure Measurements During One-lung Ventilation
Official title: An Observational Study to Determine Feasibility and Validity of Esophageal and Transpulmonary Pressure Measurements During One Lung Ventilation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
One-lung Ventilation
Keywords: One-lung ventilation
Electrical Impedance Tomography
Thoracic Surgery
Esophageal manometry
Transpulmonary Pressure
Lung-protective ventilation
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing non-cardiac surgery requiring one-lung ventilation under general anesthesia as part of clinical routine

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.

Eligibility 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

Primary outcomes:
measure: Esophageal pressure at lung collapse
timeFrame: During one-lung ventilation
Secondary outcomes:
measure: Esophageal Pressure
timeFrame: During one-lung ventilation
measure: Esophageal Pressure
timeFrame: During two-lung ventilation in the lateral position
measure: Esophageal Pressure
timeFrame: During two-lung ventilation in the supine position
measure: Optimum PEEP
timeFrame: During one-lung ventilation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: