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Cardiac Surgery SubjectsNCT07531602

Effect of PEEP on Cardiac Function

A study testing EIT Guided PEEP Trial in people with Cardiac Surgery Subjects, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The purpose of this single-center, prospective study is to evaluate the physiologic effect of changes in PEEP on biventricular mechanics and RV-pulmonary arterial (RV-PA) coupling in adult patients undergoing cardiac surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Surgery Subjects
What is being tested?
EIT Guided PEEP Trial
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
17 Jun 2026to 30 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 1. Age ≥ 18 years
  • 2. Scheduled to undergo cardiac surgery requiring general anesthesia
  • 3. Planned use of intraoperative transesophageal echocardiography (TEE) as part of routine clinical care
  • 4. Planned placement of a pulmonary artery catheter as part of clinical care (Pulmonary artery catheter placement will be performed solely based on clinical judgment by the treating anesthesia and surgical teams. At our institution, pulmonary artery catheters are routinely placed in cardiac surgery patients with clinical indications including:
  • preoperative pulmonary hypertension (e.g., estimated PCWP >20 mmHg or elevated filling pressures on preoperative echocardiography),
  • right ventricular dysfunction or suspected RV failure (preoperative visual TTE assessment),
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  • significant cardiopulmonary comorbidity,
  • or anticipated complex, prolonged, or high-acuity cardiac surgery. The research team will not influence decisions regarding catheter placement. Only patients already scheduled to receive a clinically indicated pulmonary artery catheter will be eligible for enrollment.)
  • 5. Able and willing to provide written informed consent prior to surgery

Who cannot join

  • 1. Significant arrhythmia (e.g., atrial fibrillation with uncontrolled ventricular response or other rhythm disturbances) that would interfere with reliable pressure waveform or echocardiographic measurements.
  • 2. Severe valvular disease where protocol-related PEEP changes may pose unacceptable hemodynamic risk, as determined by the clinical team.
  • 3. Significant chronic lung disease or other pulmonary pathology where PEEP adjustments may be unsafe (e.g., severe COPD with dynamic hyperinflation, bullous lung disease), at the discretion of the anesthesia team.
  • 4. Contraindication to changes in PEEP, including inability to tolerate the planned PEEP titration due to hemodynamic instability or clinician concern.
  • 5. Any contraindication to TEE (if clinically required TEE is not performed or is contraindicated, the subject will not be eligible)
  • 6. Investigator or clinical team discretion (e.g., safety concerns, inability to obtain reliable measurements, or conflict with other perioperative research protocols)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: The Effect of Positive End-Expiratory Pressure on Biventricular Mechanics in the Perioperative Setting

The purpose of this single-center, prospective study is to evaluate the physiologic effect of changes in PEEP on biventricular mechanics and RV-pulmonary arterial (RV-PA) coupling in adult patients undergoing cardiac surgery.

Read the detailed description

Positive end-expiratory pressure (PEEP) is a critical modality of mechanical ventilation but has important and often underappreciated effects on biventricular mechanics. PEEP is frequently selected based primarily on respiratory mechanics and oxygenation targets; however, increasing intrathoracic pressure may reduce RV preload by elevating right atrial pressure, while increasing transpulmonary pressure may increase RV afterload by compressing intra-alveolar pulmonary vessels and redistributing pulmonary blood flow. This is important specifically in the context of cardiac surgery where right ventricular (RV) function plays a critical role in determining postoperative morbidity and mortality. Perioperative RV dysfunction has been consistently associated with adverse outcomes, including prolonged vasopressor and inotrope requirements, difficulty weaning from cardiopulmonary bypass, longer intensive care unit stays, and increased mortality.

Right ventricular-pulmonary arterial (RV-PA) coupling provides a physiologically integrated assessment of RV performance by quantifying the relationship between RV contractility and afterload. Animal studies have shown that incremental PEEP increases can impair biventricular mechanics and precipitate RV-PA uncoupling. However, these physiologic effects have not been systematically characterized in the perioperative setting in the cardiac surgery population. This protocol seeks to address this knowledge gap by systematically evaluating biventricular mechanics and RV-PA coupling across varying PEEP levels in a controlled setting, using tools already employed in routine cardiac surgical care (pulmonary artery catheter and intraoperative TEE).

The overarching goal of this proposal is to define how perioperative positive end-expiratory pressure alters biventricular mechanics and right ventricular-pulmonary arterial coupling, to inform physiologically guided, RV-protective ventilatory strategies during cardiac surgery.

Being tested
EIT Guided PEEP Trial
Keywords
PEEP Titration, Mechanical Ventilation, Coronary Artery Disease, Right Ventricular Impairment
Medical subject headings
Coronary Artery Disease, Heart Failure

What participants receive

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

  • EIT Guided PEEP TrialProcedure or surgery

    Electrical impedance tomography (EIT) will be used to guide identification of "optimal PEEP" based on lung mechanics. After induction of anesthesia and initiation of controlled mechanical ventilation, EIT data will be collected during a brief standardized PEEP titration maneuver to assess lung recruitment and overdistension.

Study groups in NCT07531602
Study groupRoleWhat they receive
Optimized PEEP GroupExperimentalThese are patients undergoing cardiac surgery who will undergo an incremental/decremental PEEP trial using Electrical Impedance Tomography (EIT).
Receives: Procedure: EIT Guided PEEP Trial

What is being measured

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

  1. Right ventricle-pulmonary artery coupling (Ees/Ea)

    Right ventricle-pulmonary artery (RV-PA) coupling ratio (Ees/Ea) assessed using simultaneous transesophageal echocardiography and hemodynamic monitoring at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]) during a standardized stepwise PEEP titration sequence.

    Measured: During the standardized PEEP titration sequence after induction of anesthesia and before surgical intervention (approximately 20-25 minutes)

Secondary outcomes (12)
  1. Right ventricular end-diastolic volume at predefined PEEP levels

    Three-dimensional right ventricular end-diastolic volume (RVEDV) measured by transesophageal echocardiography at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]).

    Measured: During PEEP titration sequence (approximately 20-25 minutes after induction of anesthesia and prior to surgical incision)

  2. Right ventricular end-systolic volume at predefined PEEP levels

    Three-dimensional right ventricular end-systolic volume (RVESV) assessed by three-dimensional transesophageal echocardiography at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]).

    Measured: During standardized PEEP titration sequence after induction of anesthesia and prior to surgical incision (approximately 20-25 minutes)

  3. Right ventricular stroke volume at predefined PEEP levels

    Right ventricular stroke volume derived from three-dimensional transesophageal echocardiography at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]).

    Measured: During standardized PEEP titration sequence after induction of anesthesia and prior to surgical incision (approximately 20-25 minutes)

  4. Right ventricular end-diastolic pressure at predefined PEEP levels

    Right ventricular end-diastolic pressure measured via pulmonary artery catheter at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]).

    Measured: During standardized PEEP titration sequence after induction of anesthesia and prior to surgical incision (approximately 20-25 minutes)

  5. Right ventricular end-systolic pressure at predefined PEEP levels

    Right ventricular end-systolic pressure estimated using waveform-based calculation methods from pulmonary artery catheter data at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]).

    Measured: During standardized PEEP titration sequence after induction of anesthesia and prior to surgical incision (approximately 20-25 minutes)

  6. Pulmonary artery systolic pressure at predefined PEEP levels

    Pulmonary artery systolic pressure measured via pulmonary artery catheter at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]).

    Measured: During standardized PEEP titration sequence after induction of anesthesia and prior to surgical incision (approximately 20-25 minutes)

  7. Mean pulmonary artery pressure at predefined PEEP levels

    Mean pulmonary artery pressure measured via pulmonary artery catheter at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]).

    Measured: During standardized PEEP titration sequence after induction of anesthesia and prior to surgical incision (approximately 20-25 minutes)

  8. Right ventricular end-systolic elastance at predefined PEEP levels

    Right ventricular end-systolic elastance (Ees) derived using single-beat pressure-volume analysis at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]).

    Measured: During standardized PEEP titration sequence after induction of anesthesia and prior to surgical incision (approximately 20-25 minutes)

  9. Effective arterial elastance at predefined PEEP levels

    Effective arterial elastance (Ea) derived from pressure-volume analysis at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]).

    Measured: During standardized PEEP titration sequence after induction of anesthesia and prior to surgical incision (approximately 20-25 minutes)

  10. Three-dimensional right ventricular ejection fraction

    Three-dimensional right ventricular ejection fraction (3D RVEF) assessed by transesophageal echocardiography at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]) during a standardized stepwise PEEP titration sequence.

    Measured: During standardized PEEP titration sequence after induction of anesthesia and prior to surgical incision (approximately 20-25 minutes)

  11. Left ventricular ejection fraction at predefined PEEP levels

    Three-dimensional left ventricular ejection fraction (LVEF) assessed by transesophageal echocardiography at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]).

    Measured: During standardized PEEP titration sequence after induction of anesthesia and prior to surgical incision (approximately 20-25 minutes)

  12. Left ventricular stroke volume at predefined PEEP levels

    Left ventricular stroke volume derived from echocardiographic measurements at four predefined PEEP levels (optimal PEEP + 5 cmH₂O, optimal PEEP, optimal PEEP - 5 cmH₂O, and PEEP 0 cmH₂O [baseline]).

    Measured: During standardized PEEP titration sequence after induction of anesthesia and prior to surgical incision (approximately 20-25 minutes)

Timeline

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

  1. First posted15 Apr 2026
  2. Study start17 Jun 2026
  3. Primary completion30 Jul 2028 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07531602
Sponsor's protocol ID
2026P000077
Status last verified
Jun 2026
First submitted
9 Apr 2026
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bellofiore A, Vanderpool R, Brewis MJ, Peacock AJ, Chesler NC. A novel single-beat approach to assess right ventricular systolic function. J Appl Physiol (1985). 2018 Feb 1;124(2):283-290. doi: 10.1152/japplphysiol.00258.2017. Epub 2017 Oct 12.

    PubMed 29025899
  • Araos J, Glocker F, Owyang CG, Teran F, Kim J, Nieman G, Heerdt PM. Biventricular Response to Positive End-expiratory Pressure in Swine: Assessment Based on Beat-to-beat Pressure Waveform Analysis. Anesthesiology. 2025 Apr 1;142(4):767-769. doi: 10.1097/ALN.0000000000005363. Epub 2025 Feb 13. No abstract available.

    PubMed 39946198
  • Wood G, Madsen TL, Kim WY, Lyhne MD. Increasing Levels of Positive End-expiratory Pressure Cause Stepwise Biventricular Stroke Work Reduction in a Porcine Model. Anesthesiology. 2024 Feb 1;140(2):240-250. doi: 10.1097/ALN.0000000000004821.

    PubMed 37905995
  • Acosta P, Santisbon E, Varon J. "The use of positive end-expiratory pressure in mechanical ventilation". Crit Care Clin. 2007 Apr;23(2):251-61, x. doi: 10.1016/j.ccc.2006.12.012.

    PubMed 17368169
  • Ahmed U, Mahmood F, Nicoara A, Kiarad V. Right Ventricular Function and Echocardiographic Pressure-Volume Loops: Overview and Perioperative Clinical Implications. J Cardiothorac Vasc Anesth. 2025 Oct;39(10):2857-2865. doi: 10.1053/j.jvca.2025.05.019. Epub 2025 May 17.

    PubMed 40483247
  • Kiarad V, Mahmood F, Hedayat M, Yunus R, Nicoara A, Liu D, Chu L, Senthilnathan V, Kai M, Khabbaz K. Intraoperative right ventricular end-systolic pressure-volume loop analysis in patients undergoing cardiac surgery: A proof-of-concept methodology. JTCVS Open. 2024 Sep 26;22:225-234. doi: 10.1016/j.xjon.2024.09.020. eCollection 2024 Dec.

    PubMed 39780800

Questions about this trial

What is this clinical trial studying?

A study testing EIT Guided PEEP Trial in people with Cardiac Surgery Subjects, 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 9 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 1 Jul 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?

This study is still under way. Results are not available in the source record yet.

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?

Right ventricle-pulmonary artery coupling (Ees/Ea) (time frame: During the standardized PEEP titration sequence after induction of anesthesia and before surgical intervention (approximately 20-25 minutes)). 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 NCT07531602, which also lists 6 linked publications.

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 1 Jul 2026.

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