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Slower than expected enrollment
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-lung ventilation | Other | One-lung ventilation as part of routine clinical care for patients undergoing thoracic surgery under general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Esophageal Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing non-cardiac surgery requiring one-lung ventilation under general anesthesia as part of clinical routine
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | One-lung Ventilation | All participants enrolled in this one-arm study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | One-lung Ventilation | All participants enrolled in this one-arm study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | insufficient data quality in 3 patients | Posted | Median | Inter-Quartile Range | cmH2O | During one-lung ventilation |
|
|
from enrollment until end of follow-up, end of anesthesia (end of stay in the post-anesthesia care unit, typically the same day)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | All patients included in this one-arm study | 0 |
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This study was closed due to lack of enrollment. Targeted sample size was not reached.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maximilian Schaefer, MD | Beth Israel Deaconess Medical Center | 617-632-7034 | msschaef@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2020 | Feb 3, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D061810 | One-Lung Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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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 |
| 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 |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
| Secondary | Esophageal Pressure | Esophageal Pressure during one-lung ventilation in the lateral position at airway closure as assessed by pressure-volume curves | Not Posted | During one-lung ventilation | Participants |
| Secondary | Esophageal Pressure | Esophageal Pressure during two-lung ventilation in the lateral position at airway closure as assessed by pressure-volume curves | Not Posted | During two-lung ventilation in the lateral position | Participants |
| Secondary | Esophageal Pressure | Esophageal Pressure during two-lung ventilation in the supine position at airway closure as assessed by pressure-volume curves | Not Posted | During two-lung ventilation in the supine position | Participants |
| Secondary | Optimum PEEP | PEEP during PEEP titration that provides optimum trade-off between lung collapse and overdistension, as measured by Electrical Impedance Tomography | Not Posted | During one-lung ventilation | Participants |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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