PEEP for Cardiac Surgery Patients

AK
VK
Overseen ByVahid Kiarad, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using PEEP, a setting on a breathing machine, to assist patients undergoing heart surgery. Researchers aim to understand how varying PEEP levels impact heart function and blood flow during surgery. The trial uses a special tool, Electrical Impedance Tomography (EIT), to guide these adjustments. It targets adults undergoing heart surgery, particularly those with conditions like pulmonary hypertension or right-sided heart issues. Participants must be scheduled for surgery with specific monitoring tools already planned as part of their care. As an unphased trial, this study allows patients to contribute to innovative research that could enhance surgical outcomes for individuals with complex heart conditions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this protocol is safe for cardiac surgery patients?

Research has shown that using EIT-guided PEEP (Positive End-Expiratory Pressure) is generally safe for patients. In one study, patients who received this treatment had better oxygen levels during surgery compared to other methods. This technique uses electrical signals to determine the optimal PEEP levels for each person, helping to protect the lungs during surgery.

Another study found that this method improves lung function without causing serious side effects. Safety checks are in place during these treatments; for instance, if a patient's heart rate or breathing becomes too fast or too slow, doctors may pause the process to ensure safety.

Overall, EIT-guided PEEP appears to be a safe option for patients undergoing surgery, with studies showing positive results and few side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the EIT Guided PEEP Trial because it offers a new method for optimizing ventilation settings during cardiac surgery. Unlike standard practices that rely on fixed PEEP (Positive End-Expiratory Pressure) settings, this approach uses Electrical Impedance Tomography (EIT) to tailor PEEP levels to each patient's unique lung characteristics. This personalized strategy could improve lung function and outcomes during and after surgery, potentially reducing complications and enhancing recovery.

What evidence suggests that this EIT Guided PEEP Trial is effective for cardiac surgery patients?

Research has shown that using Electrical Impedance Tomography (EIT) to guide positive end-expiratory pressure (PEEP) can significantly improve oxygen distribution in the lungs during surgery. In this trial, participants in the Optimized PEEP Group will undergo an incremental/decremental PEEP trial using EIT. Studies have found that EIT-guided PEEP distributes air more evenly in the lungs and increases oxygen levels more effectively than traditional methods. For patients with low oxygen levels, this approach proved more effective in boosting blood oxygen. The technique is non-invasive, requiring no surgery, and can be performed at the bedside, making it a safe and practical choice. Overall, EIT-guided PEEP has demonstrated clear benefits in enhancing lung function during surgery.12678

Are You a Good Fit for This Trial?

This trial is for adults (18+) scheduled for cardiac surgery under general anesthesia who will have a pulmonary artery catheter and transesophageal echocardiography as part of their care. People with severe valve disease, serious lung problems, certain heart rhythm issues, or other safety concerns cannot join.

Inclusion Criteria

I am 18 years old or older.
I am scheduled for heart surgery with general anesthesia.
I am scheduled to have a TEE during my surgery as part of my routine care.
See 2 more

Exclusion Criteria

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
I cannot safely have changes made to my breathing machine settings.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Assessment

Evaluation of biventricular mechanics and RV-PA coupling using PEEP titration sequence

20-25 minutes
1 visit (in-person, during surgery)

Follow-up

Participants are monitored for safety and effectiveness after the perioperative assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EIT Guided PEEP Trial

Trial Overview

The study tests how adjusting PEEP (a setting on the breathing machine) affects heart function during cardiac surgery. The amount of PEEP used is guided by EIT imaging to see its impact on both sides of the heart and blood flow to the lungs.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Optimized PEEP GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Recruited
12,930,000+

Citations

A Prospective, Non-Randomized Interventional Study - PMC

EIT-guided individualized PEEP stabilized the improvement in ventilation distribution and oxygenation. Individual PEEP varies with EIT measures, ...

Study Details | NCT07531602 | Effect of PEEP on Cardiac ...

Electrical impedance tomography (EIT) will be used to guide identification of "optimal PEEP" based on lung mechanics. After induction of ...

The impact of PEEP-guided electrical impedance ...

In this randomized controlled trial, 108 patients with PaO₂/FiO₂ below 200 mmHg were allocated to EIT-guided PEEP after a recruitment maneuver ( ...

Electrical impedance tomography-guided positive...

EIT-guided individual PEEP setting significantly improved perioperative oxygenation index compared with other modalities of PEEP ventilation strategies for ...

Electrical impedance tomography during open heart surgery ...

This case series demonstrates for the first time that EIT is feasible during open heart surgery and in patients with open chest on the ICU using adapted belts ...

Individualized PEEP Guided by Electrical Impedance ...

Background: Optimal positive end-expiratory pressure (PEEP) is essential for maintaining alveolar recruitment and preventing postoperative ...

Electrical impedance tomography guided positive end ... - PMC

This study aims to develop a comprehensive view of the efficacy and long-term prognosis of EIT-guided PEEP compared to other conventional approaches.

A compass for the safe route to optimal PEEP

Electrical impedance tomography (EIT) is a non-invasive bedside tool that monitors in real-time ventilation distribution. Aim of this narrative review is ...