Preventing Inadvertent Hypothermia in Paediatric Neurosurgery in Malawi

• Register: ClinicalTrials.gov
• Last refreshed on: 8 March 2021
• Main ID: NCT02975817
• Date of registration: 24/11/2016
• Prospective Registration: No
• Primary sponsor: Oslo University Hospital
• Public title: Preventing Inadvertent Hypothermia in Paediatric Neurosurgery in Malawi
• Scientific title: Preventing Inadvertent Hypothermia in Children Undergoing Elective Neurosurgery in Malawi - a Prospective Randomized Clinical Trial
• Date of first enrolment: June 2016
• Target sample size: 76
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02975817
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Malawi

Contacts

• Name: Anders C Feyling, MD
• Affiliation: Oslo University Hospital

Key inclusion & exclusion criteria

Inclusion criteria:

I. Age under 12 years. II. Ensured bed in HDU for postoperative management. III. Undergoing
general anaesthesia with endotracheal intubation for planned cranial procedures; e.g.
craniotomies, ventriculo-peritoneal shunt placements, endoscopic third ventriculostomies
and similar procedures with a predominantly cranial access.

IV. Informed parental/guardian consent given

Exclusion criteria:

I. Pts. aged 12 years or older. II. Pts. with a temperature upon arrival at the anaesthetic
suite lower than 36,0 °C III. Pts. with a temperature upon arrival at the anaesthetic suite
greater than 37,5°C IV. Pts. judged to be unsuited for the standardized anaesthetic
technique chosen (due to known allergy, known or suspected difficult airway requiring other
anaesthetic interventions, cardiovascular conditions incompatible with the standard
anaesthetic agents or due to any other condition where the chosen technique is deemed
unsafe)



Age minimum: N/A
Age maximum: 11 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypothermia

Intervention(s)

Other: Hibler's

Other: Warm Air

Primary Outcome(s)

incidence of hypothermia [Time Frame: from start of surgery till end of surgery]

Secondary Outcome(s)

Degree of alertness [Time Frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay]

incidence of postoperative shivering [Time Frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay]

Oxygen requirements [Time Frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay]

Proportion of surgery time spent normothermic [Time Frame: from start of surgery till end of surgery]

Secondary ID(s)

hypomalawi

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Malawi College of Medicine