CompletedNot Applicable

Preventing Inadvertent Hypothermia in Paediatric Neurosurgery in Malawi

Malawi76 participantsStarted 2016-06

Plain-language summary

The investigators wish to undertake a randomized controlled non-inferiority trial to evaluate the ability of a simple and low-cost method (Hibler´s method of wrapping the patient in multiple insulating layers) to prevent intraoperative heat-loss in children undergoing neurosurgery under anesthesia in Malawi. The control group will be heated actively with the use of warm-air blankets. The aim of this study is to evaluate whether Hibler´s method can provide a cheap and technically simple way of adequately preserving the patients´ core temperature in the operating theatre in a resource-poor setting.

Who can participate

Age range11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

incidence of hypothermia

Timeframe: from start of surgery till end of surgery

Trial details

NCT IDNCT02975817

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-12