Esophageal Pressure Measurements During One-lung Ventilation

NCT ID: NCT04725318

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-19

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Surgery One-lung Ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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One-lung ventilation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maximilian S Schaefer

Associate Professor of Anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maximilian S Schaefer, MD

Role: CONTACT

317 306 3216

Elias Baedorf-Kassis, MD

Role: CONTACT

Facility Contacts

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Maximilian S Schaefer, MD

Role: primary

617 632 0728

Other Identifiers

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2020P-000811

Identifier Type: -

Identifier Source: org_study_id

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