Actively Recruiting

Age: 1Day - 17Years
All Genders
ID07184476

Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient

Led by Boston Children's Hospital · Updated on 2026-05-28

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Pediatric patients undergoing cardiac surgery, particularly those with ventricular septal defect or tetrology of Fallot, experience significant physiological changes during surgery and cardiopulmonary bypass (CPB). Traditional monitoring focuses on large blood vessels, but this may not reflect the true state of smaller vessels. Researchers are evaluating a handheld device called the Cytocam incident dark-field (IDF) microcirculatory camera, which provides real-time video and data of the microvascular circulation in these patients. This observational study involves using the Cytocam device to monitor microvascular blood flow at specific times: after intubation in the operating room, 10 minutes after CPB starts, after the cross clamp is placed, hourly during CPB, after CPB ends, and every 4 hours during the first 48 hours in the intensive care unit. The study includes patients with cyanotic physiology related to tetrology of Fallot and those with acyanotic lesions undergoing ventricular septal defect repair. Participants will be monitored continuously using the Cytocam device during the surgical and recovery periods. Researchers will assess measures such as capillary density, microcirculatory flow index, tissue perfusion surrogates, and signs of acute kidney injury. Secondary outcomes include ventilator duration and adverse events. The study will follow patients for the first 48 hours after surgery to gather these data and understand microvascular changes during and after cardiac surgery.

CONDITIONS

Brief Title

Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient

Who Can Participate

Age: 1Day - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients with primary diagnosis of ventricular septal defect or tetrology of Fallot
Not Eligible

You will not qualify if you...

  • Critical airway
  • Congenital genetic abnormality of the mouth or tongue

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Surgery day and first 48 hours post-surgery

Participants undergo cardiac surgery with monitoring of microvascular circulation during and immediately after surgery.

Continuous monitoring from operation room through first 48 hours in intensive care unit with assessments after intubation, during cardiopulmonary bypass, and every 4 hours post-operatively

Trial Site Locations

Total: 1 location

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

S

Sharon Boyle

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

The microcirculation image quality score: development and preliminary evaluation of a proposed approach to grading quality of image acquisition for bedside videomicroscopy.

Michael J Massey, Ethan Larochelle, Gabriel Najarro...

https://pubmed.ncbi.nlm.nih.gov/23972316

Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference.

Pediatric Acute Lung Injury Consensus Conference Group

https://pubmed.ncbi.nlm.nih.gov/25647235

The Reproducibility of the Point of Care Microcirculation (POEM) Score When Used to Assess Critically Ill Patients: A Multicenter Prospective Observational Study.

James C Watchorn, Hithem Fargaly, Muhammad Gilani...

https://pubmed.ncbi.nlm.nih.gov/31764623