Effect of PEEP on Cardiac Function

NCT07531602 | Not Yet Recruiting

• 1 other identifier: 2026P000077
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery Subjects

Keywords

PEEP Titration; Mechanical Ventilation; Coronary Artery Disease; Right Ventricular Impairment

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (12)

• Right ventricular end-diastolic volume at predefined PEEP levels

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

• Right ventricular end-systolic volume at predefined PEEP levels

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

• Right ventricular stroke volume at predefined PEEP levels

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

• Right ventricular end-diastolic pressure at predefined PEEP levels

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

• Right ventricular end-systolic pressure at predefined PEEP levels

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

Other Outcomes (2)

• Oxygen saturation at predefined PEEP levels

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

• Plateau pressure at predefined PEEP levels

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

Study Arms (1)

Optimized PEEP Group

EXPERIMENTAL

These are patients undergoing cardiac surgery who will undergo an incremental/decremental PEEP trial using Electrical Impedance Tomography (EIT).

Procedure: EIT Guided PEEP Trial

Interventions

EIT Guided PEEP Trial PROCEDURE

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.

Optimized PEEP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years
• \. Scheduled to undergo cardiac surgery requiring general anesthesia
• \. Planned use of intraoperative transesophageal echocardiography (TEE) as part of routine clinical care
• \. 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),
• 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.)
• \. Able and willing to provide written informed consent prior to surgery

You may not qualify if:

• \. Significant arrhythmia (e.g., atrial fibrillation with uncontrolled ventricular response or other rhythm disturbances) that would interfere with reliable pressure waveform or echocardiographic measurements.
• \. Severe valvular disease where protocol-related PEEP changes may pose unacceptable hemodynamic risk, as determined by the clinical team.
• \. 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.
• \. Contraindication to changes in PEEP, including inability to tolerate the planned PEEP titration due to hemodynamic instability or clinician concern.
• \. Any contraindication to TEE (if clinically required TEE is not performed or is contraindicated, the subject will not be eligible)
• \. Investigator or clinical team discretion (e.g., safety concerns, inability to obtain reliable measurements, or conflict with other perioperative research protocols)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

• 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.

  PMID: 29025899 BACKGROUND

• 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.

  PMID: 39946198 BACKGROUND

• 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.

  PMID: 37905995 BACKGROUND

• 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.

  PMID: 17368169 BACKGROUND

• 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.

  PMID: 40483247 BACKGROUND

• 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.

  PMID: 39780800 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Arian Karimitar, PhD

CONTACT

6176328056; akarimit@bidmc.harvard.edu

Vahid Kiarad, MD, MPH

CONTACT

vkiarad@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)