Recruiting

Cytocam

Sponsor:

Boston Children's Hospital

Code:

NCT07184476

Conditions

Tetrology of Fallot

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The pediatric cardiac surgery patient endures a tremendous number of physiologic alterations during surgery and cardiopulmonary bypass (CPB) that lasts well into the recovery period. Most of the hemodynamic data are assessed and treated with macrovascular assessment tools such as blood pressure and central venous line measures. Studies show there may be an incoherence of macrovascular to microvascular assessment; i.e. a patient with a stable macrovascular status may not be in the state of microvascular stability. The use of a handheld device called Cytocam incident dark-field (IDF) microcirculatory camera (Braedius Medical, Huizen, Netherlands) gives real-time video screening and data feedback to assess the microvasculature in the hemodynamically labile patient.

Conditions

Tetrology of Fallot

Study ID

NCT07184476

Start date

Mar 18, 2026

Status verified date

Apr, 2026

Completion date

Mar 17, 2027

Anticipated

Primary completion date

Mar 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients with primary diagnosis of ventricular septal defect or tetrology of Fallot

Exclusion Criteria:

  • Critical airway, congenital genetic abnormality of the mouth/tongue

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary Tetrology of Fallot repair

Cyanotic physiology with Tetrology of Fallot w/pulmonary stenosis or atresia

Primary ventricular septal defect repair (VSD)

Acyanotic lesion with VSD repair patch graft

Primary outcome measure

  • Braedius Cytocam efficacy in the pediatric surgery patient [ Time Frame: - After intubation in operation room - 10 minutes after cardiopulmonary bypass (CPB) initiated - after cross clamp placed - every hour on CPB - after CPB ends - every 4 hours during the first 48 hours after admitted to the intensive care unit ]
  • Capillary density measurements [ Time Frame: - After intubation in operation room - 10 minutes after cardiopulmonary bypass (CPB)initiated - After cross clamp placed - every hour on CPB - after CPB ends - every 4 hours during the first 48 hours after admitted to the intensive care unit ]
  • Microcirculatory flow index grading [ Time Frame: - After intubation in operation room - 10 minutes after cardiopulmonary bypass (CPB) initiated - after cross clamp placed - every hour on CPB - after CPB ends - every 4 hours during the first 48 hours after admitted to the intensive care unit ]
  • Surrogates of tissue perfusion and acute kidney injury [ Time Frame: - After intubation in operation room - 10 minutes after cardiopulmonary bypass (CPB) initiated - after cross clamp placed - every hour on CPB - after CPB ends - every 4 hours during the first 48 hours after admitted to the intensive care unit ]

Central Contacts and Locations

Central contacts

Sharon Boyle

6173557077sharon.boyle@cardio.chboston.org

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sharon Boyle

6173557077sharon.boyle@cardio.chboston.org

sharon.boyle@cardio.chboston.org

More Information

Sponsor

Boston Children's Hospital

Last update posted

May 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-05-28.