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
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|Condition or disease||Intervention/treatment|
|Surgery One-lung Ventilation||Other: One-lung ventilation|
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 Type :||Observational|
|Estimated Enrollment :||25 participants|
|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|
- Other: One-lung ventilation
One-lung ventilation as part of routine clinical care for patients undergoing thoracic surgery under general anesthesia
- 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
- 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
- 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
- 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
- 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
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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|
- adult patients undergoing non-cardiac surgery with OLV
- Active respiratory infection
- Prior lung resection
- Prior esophageal/gastric surgery
- Esophageal varices
- Patients under effective anticoagulation at time of surgery
- Inability to give written informed consent
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
|Contact: Maximilian S Schaefer, MD||317 306 email@example.com|
|Contact: Elias Baedorf-Kassis, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Maximilian S Schaefer, MD 617-632-0728 email@example.com|
|Responsible Party:||Maximilian S Schaefer, Assistant Professor of Anaesthesia, Beth Israel Deaconess Medical Center|
|Other Study ID Numbers:||
|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|
|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|
Electrical Impedance Tomography