Children undergoing open-heart surgery Surgery
Conditions
Interventions
This is a single-centre, prospective, observational, proof-of-concept study with an aim to enrol 50 children. The study is expected to run over 18 months.
Method of recruitment:
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age and weight appropriate for urinary catheterisation of size 8 Fr and above (age > 4 months and less than 16 years or weight >6 kg for size 8Fr urinary catheter) 2. Open heart surgery with cardiopulmonary bypass 3. Informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Age greater than or equal to 16 years 2. Recent history of oesophageal or urinary bladder surgery (less than 4 weeks) 3. Contraindication for urethral catheterisation due to anatomical malformations, urethral obstruction or haemorrhage 4. Generalised bleeding state immediately prior to the cardiac surgery 5. A recent history of otitis media or discharge from both ears (<7 days before surgery)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Urinary bladder temperature measurement using a temperature sensing Foley’s urinary catheter at baseline then every 10 minutes for a further 8 hours 2. Oesophageal temperature measurement using a routine central temperature measuring probe at baseline then every 10 minutes for a further 8 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Axillary (using an electronic thermometer) and aural temperature (using an infrared ear thermometer) measured at baseline and every hour for a further 8 hours 2. Urinary output measured using a standard graduated urine collection bag at baseline and every hour for a further 8 hours | — |
Countries
England, United Kingdom
Outcome results
None listed