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Esophageal Pressure Measurements During One-lung Ventilation

An Observational Study to Determine Feasibility and Validity of Esophageal and Transpulmonary Pressure Measurements During One Lung Ventilation

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04725318
Enrollment
6
Registered
2021-01-26
Start date
2020-11-19
Completion date
2021-12-31
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

One-lung Ventilation, Surgery

Keywords

One-lung ventilation, Electrical Impedance Tomography, Thoracic Surgery, Esophageal manometry, Transpulmonary Pressure, Lung-protective ventilation

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.

Interventions

OTHEROne-lung ventilation

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

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Esophageal Pressure at Lung CollapseDuring one-lung ventilationEsophageal 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

MeasureTime frameDescription
Esophageal PressureDuring one-lung ventilationEsophageal Pressure during one-lung ventilation in the lateral position at airway closure as assessed by pressure-volume curves
Optimum PEEPDuring one-lung ventilationPEEP during PEEP titration that provides optimum trade-off between lung collapse and overdistension, as measured by Electrical Impedance Tomography

Countries

United States

Baseline characteristics

Characteristic
Age, Continuous54 years
Race/Ethnicity, Customized
Ethnicity
Asian
1 Participants
Race/Ethnicity, Customized
Ethnicity
Non-hispanic White
5 Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 6
other
Total, other adverse events
0 / 6
serious
Total, serious adverse events
0 / 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026