Use of a new blood test and a special camera for recording flow in the small blood vessels to identify children with poor outcomes after cardiac surgery

The role of novel carbon-dioxide and oxygen based blood markers and Incident dark field micro-circulation imaging (IDFI) to identify children with high risk of adverse outcomes after cardiac surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10476641

Enrollment

Registered

2018-07-31

Start date

2019-01-01

Completion date

Unknown

Last updated

2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac surgery involving cardiopulmonary bypass Circulatory System Cardiac surgery involving cardiopulmonary bypass

Interventions

Alll participants will undergo the following tests/observations around the period of their cardiopulmonary bypass (CPB): 1. Incident Dark Field Microcirculation Imaging (IDFI) measurem

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged up to 16 years 2. Requiring open heart surgery with cardio pulmonary bypass 3. Existing arterial and central venous catheters 4. Informed consent

Exclusion criteria

Exclusion criteria: 1. Large residual shunts, 2. Children with underlying lung disease requiring long term respiratory support or oxygen therapy (Persistent FiO2 requirement of >30% and/or use of nasal continuous positive airway pressure (nCPAP) or positive pressure ventilation for more then 28 days immediately before the date of the surgery)

Design outcomes

Primary

Measure	Time frame
The following will be measured at the point of PICU admission and 6 and 24 hours afterwards: 1. The relationship between the sequential central venous-to-arterial CO2 content difference and arterial-to-mixed venous O2 content difference ratio and composite time to complete organ failure resolution (CTCOFR) score, assessed using Spearman's Rho test and coefficient determination of R². Central venous-to-arterial CO2 content difference and arterial-to-mixed venous O2 content difference ratio will be calculated at the baseline (point of admission to PICU), and 6, 12 and 24 hours after admission. The CTCOFR score will be calculated 30 days after admission to PICU) 2. Practicability of sequential use of IDFI at beside, assessed using: 2.1. Recording ease of data capturing using a 1-3 scale (1 indicates "extremely difficult", 2 indicates "difficult" and 3 indicates "easy") 2.2. Quality of images, assessed by visual inspection on aspects such as illumination, focus, stability and pressure artefacts (randomly selected 8 sets from each time frame after PICU) 2.3. Patient compliance and concurrent use of anaesthetic agents 2.4. Reproducibility of CytoCam IDF imaging, assessed used the intraclass correlation efficient (ICC) by performing 2 subsequent measurement sets by 2 different trained operators within the same time frame	—

Measure

Time frame

The following will be measured at the point of PICU admission and 6 and 24 hours afterwards: 1. The relationship between the sequential central venous-to-arterial CO2 content difference and arterial-to-mixed venous O2 content difference ratio and composite time to complete organ failure resolution (CTCOFR) score, assessed using Spearman's Rho test and coefficient determination of R². Central venous-to-arterial CO2 content difference and arterial-to-mixed venous O2 content difference ratio will be calculated at the baseline (point of admission to PICU), and 6, 12 and 24 hours after admission. The CTCOFR score will be calculated 30 days after admission to PICU) 2. Practicability of sequential use of IDFI at beside, assessed using: 2.1. Recording ease of data capturing using a 1-3 scale (1 indicates "extremely difficult", 2 indicates "difficult" and 3 indicates "easy") 2.2. Quality of images, assessed by visual inspection on aspects such as illumination, focus, stability and pressure artefacts (randomly selected 8 sets from each time frame after PICU) 2.3. Patient compliance and concurrent use of anaesthetic agents 2.4. Reproducibility of CytoCam IDF imaging, assessed used the intraclass correlation efficient (ICC) by performing 2 subsequent measurement sets by 2 different trained operators within the same time frame

—

Secondary

Measure	Time frame
The agreement between the absolute and delta values of the following markers of tissue hypoxia (ratio between central venous-to-arterial CO2 content difference and arterial-to-mixed venous O2 content difference, mixed veno-arterial CO2 tension difference, serum lactate and central venous saturations) and microcirculatory assays (total and perfused vessel density) at the baseline and 6 and 24 hours after PICU admission. This relationship will be determined using Spearman's Rho test and coefficient determination of R².	—

Measure

Time frame

The agreement between the absolute and delta values of the following markers of tissue hypoxia (ratio between central venous-to-arterial CO2 content difference and arterial-to-mixed venous O2 content difference, mixed veno-arterial CO2 tension difference, serum lactate and central venous saturations) and microcirculatory assays (total and perfused vessel density) at the baseline and 6 and 24 hours after PICU admission. This relationship will be determined using Spearman's Rho test and coefficient determination of R².

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026