SurgeryNCT04725318

Esophageal Pressure Measurements During One-lung Ventilation

An observational study of Surgery and One-lung Ventilation, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgery, One-lung Ventilation
What is being tested?: One-lung ventilation
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 19 Nov 2020to 31 Dec 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients undergoing non-cardiac surgery requiring one-lung ventilation under general anesthesia as part of clinical routine

Who may be able to join

adult patients undergoing non-cardiac surgery with OLV

Who cannot join

COPD
Active respiratory infection
Prior lung resection
Prior esophageal/gastric surgery
Esophageal varices
Patients under effective anticoagulation at time of surgery

Show all 9Show fewer

Pacemaker/ICD
Pregnancy
Inability to give written informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

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

Read the 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.

Conditions: Surgery, One-lung Ventilation
Being tested: One-lung ventilation
Keywords: One-lung ventilation, Electrical Impedance Tomography, Thoracic Surgery, Esophageal manometry, Transpulmonary Pressure, Lung-protective ventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: During one-lung ventilation

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 202031 Dec 2021

First posted26 Jan 2021
Study start19 Nov 2020
Primary completion24 Feb 2021
Study completion31 Dec 2021

Why it stopped: Slower than expected enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SurgeryStudies of the same condition, open and under way.
More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04725318
Sponsor's protocol ID: 2020P-000811
Status last verified: Feb 2026
First submitted: 19 Jan 2021
Last updated: 19 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study to Determine Feasibility and Validity of Esophageal and Transpulmonary Pressure Measurements During One Lung Ventilation
ClinicalTrials.gov ID: NCT04725318
Acronym / sponsor ID: 2020P-000811
Conditions: Surgery, One-lung Ventilation
Keywords: One-lung ventilation, Electrical Impedance Tomography, Thoracic Surgery, Esophageal manometry, Transpulmonary Pressure, Lung-protective ventilation
Study type: Observational
Recruitment status: TerminatedReason stopped: Slower than expected enrollment
Enrolment: 6 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Study start: 19 Nov 2020 (actual)
Primary completion: 24 Feb 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 26 Jan 2021 (actual)
Results: Posted 19 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing non-cardiac surgery requiring one-lung ventilation under general anesthesia as part of clinical routine

Key inclusion criteria (1 listed)

adult patients undergoing non-cardiac surgery with OLV

Key exclusion criteria (9 listed)

COPD
Active respiratory infection
Prior lung resection
Prior esophageal/gastric surgery
Esophageal varices

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
One-lung ventilationOne-lung ventilation as part of routine clinical care for patients undergoing thoracic surgery under general anesthesia	Other	–

Primary outcome

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

4 secondary outcomes

Esophageal Pressure
Time frame: During one-lung ventilation
Esophageal Pressure
Time frame: During two-lung ventilation in the lateral position
Esophageal Pressure
Time frame: During two-lung ventilation in the supine position
Optimum PEEP
Time frame: During one-lung ventilation

Results and safety

Results posted to the registry on 19 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
One-lung Ventilation	6	6

Primary outcome: Esophageal Pressure at Lung Collapse

Time frame: During one-lung ventilation. Median (Inter-Quartile Range). Unit: cmH2O

Measure	All Patients n = 3
Value	0 (-0.054 to 2.962)

Population analysed: insufficient data quality in 3 patients

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment until end of follow-up, end of anesthesia (end of stay in the post-anesthesia care unit, typically the same day). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): This study was closed due to lack of enrollment. Targeted sample size was not reached.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and One-lung Ventilation, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Esophageal Pressure at Lung Collapse (time frame: During one-lung ventilation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04725318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.