Trial Outcomes & Findings for Esophageal Pressure Measurements During One-lung Ventilation (NCT NCT04725318)

NCT ID: NCT04725318

Last Updated: 2026-02-19

Results Overview

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

Recruitment status

TERMINATED

Target enrollment

6 participants

Primary outcome timeframe

During one-lung ventilation

Results posted on

2026-02-19

Participant Flow

Participant milestones

Participant milestones
Measure
One-lung Ventilation
All participants enrolled in this one-arm study
Overall Study
STARTED
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Esophageal Pressure Measurements During One-lung Ventilation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
One-lung Ventilation
n=6 Participants
All participants enrolled in this one-arm study
Age, Continuous
54 years
n=4 Participants
Sex: Female, Male
Female
3 Participants
n=4 Participants
Sex: Female, Male
Male
3 Participants
n=4 Participants
Race/Ethnicity, Customized
Ethnicity · Non-hispanic White
5 Participants
n=4 Participants
Race/Ethnicity, Customized
Ethnicity · Asian
1 Participants
n=4 Participants

PRIMARY outcome

Timeframe: During one-lung ventilation

Population: insufficient data quality in 3 patients

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

Outcome measures

Outcome measures
Measure
All Patients
n=3 Participants
All patients enrolled in this one-arm study
Esophageal Pressure at Lung Collapse
0 cmH2O
Interval -0.054 to 2.962

SECONDARY outcome

Timeframe: During one-lung ventilation

Esophageal Pressure during one-lung ventilation in the lateral position at airway closure as assessed by pressure-volume curves

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During one-lung ventilation

PEEP during PEEP titration that provides optimum trade-off between lung collapse and overdistension, as measured by Electrical Impedance Tomography

Outcome measures

Outcome data not reported

Adverse Events

All Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maximilian Schaefer, MD

Beth Israel Deaconess Medical Center

Phone: 617-632-7034

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place