None listed
Conditions
Brief summary
Critically unwell children admitted to intensive care commonly develop fluid accumulation which is associated with prolonged time in intensive care, prolonged duration of mechanical ventilation and death. Despite this, the measurements of fluid accumulation are inaccurate or have not been previously measured, particularly for fluid accumulation in skin and tissues (oedema). In this study we aim to measure fluid accumulation in 100 children - both total body and in skin in those requiring mechanical ventilation in the intensive care. This will be performed at admission to the intensive care, at 24 hours and 48 hours after presentation. The main measurements will include total body weight, 3D imaging of the eyes/face, limb circumferences and an oedema clinical score. We will also investigate potential causes in addition to fluid administration such as injury to blood vessels and inflammation. In addition we will also look at the association between degree of fluid accumulation and intensive care outcomes such as the length of stay, duration of mechanical ventilation, organ injury and survival. This study will add valuable information about how frequent fluid accumulation is in critically unwell children, validate its measurement, explore novel methods for detection and explore many potential causes.
Interventions
A prospective study in 100 mechanically ventilated critically ill children measuring the prevalence and evolution of fluid overload and oedema over 48 hours, standardise the way they are quantified, investigate their relationship and investigating aetiological factors such as fluid administration, endothelial dysfunction and inflammation.
The study will collect patient data for 48 hours and intensive outcome data at intensive care discharge.
Fluid overload will be quantified by measuring change
A prospective study in 100 mechanically ventilated critically ill children measuring the prevalence and evolution of fluid overload and oedema over 48 hours, standardise the way they are quantified, investigate their relationship and investigating aetiological factors such as fluid administration, endothelial dysfunction and inflammation. The study will collect patient data for 48 hours and intensive outcome data at intensive care discharge. Fluid overload will be quantified by measuring change in weight between baseline and subsequent time points and will be used in the primary analysis. In addition change in fluid balance will be measured from net change in intake and output using fluid balance charts. Facial oedema will be quantified using 3D imaging. We have developed the process for performing such images and aligning interval images to quantify change from baseline. We have also devised a clinical oedema score and validated it in a pilot study. We will also measure change in mid-arm and mid-leg circumference. These will be performed at all 3 time point. Standard methods for measuring fluid overload exist and we will use this as part of this study. Oedema has not been previously quantified in the context of critical illness. We aim to validate clinical and objective measures (3D imaging) of change in tissue oedema.
Sponsors
The Royal Children's Hospital
Eligibility
Sex/Gender
All
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Mechanically ventilated at enrolment or expected to be intubated upon elective PICU admission 2. Admitted to the PICU within previous 72 hours 3. Expected to be mechanically ventilated until the day after tomorrow 4. Expected to have arterial or venous access for 48 hours after enrolment 5. Can be safely and accurately weighed
Exclusion criteria
1. Unable to be weighed safely (haemodynamic instability, traumatic brain injury and unstable intracranial pressure, unsecured spinal injury, severe orthopaedic injuries, insecure endotracheal tube) 2. Children expected to stay in PICU less than 48 hours 3. Cerebral venous obstruction/proximal upper limb, upper leg venous obstruction or thrombosis/ cavo- pulmonary shunt 4. Ocular/facial injury/Surgery 5. Inability to lie supine in a fixed position 6. Prone positioning in the 6 hours prior to enrolment 7. Known protein losing states – e.g. Nephrotic syndrome, protein losing enteropathy, lymphangiectasia 8. Prior enrolment in the same study 9. Expected weight > 65 kg 10. COVID-19 positive or clinical suspicion of COVID-19
Outcome results
None listed