NCT02975817

Preventing Inadvertent Hypothermia in Paediatric Neurosurgery in Malawi

Preventing Inadvertent Hypothermia in Children Undergoing Elective Neurosurgery in Malawi - a Prospective Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 11 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hypothermia in the perioperative setting is receiving increasing attention in anaesthetic and surgical care. The paediatric age group is arguably at increased risk and thus deserves more intensive focus. The investigators wish to undertake a randomized controlled non-inferiority study in which two different modalities for preventing inadvertent intraoperative hypothermia are compared. The trial will be carried out in a paediatric neurosurgical population in a South-East African regional tertiary care hospital. The primary objective is to determine whether a low cost and simple method can be as effective and safe as a more expensive and technically demanding method. The goal is to recruit 40 patients in each of the two study arms. Patients younger than 12 years of age presenting for scheduled neurosurgery will be approached and given information about the study. If informed consent (and assent, where applicable) is obtained, participants will be randomized to one of the two different techniques; either passive heat preservation using what has become known as Hibler´s method (interventional group) or active warming with warm-air blankets (control group). Throughout the study period core temperature will be measured continuously, both for purposes of data accuracy and to maintain safety standards. Primary study outcomes focus on the comparative ability of the methods in maintaining acceptable core temperatures. The trial will also examine a number of secondary end-points such as prevalence of shivering, conscious level, analgesia requirements, oxygenation and overall cost. Upon completion of the study the investigators will seek to publish the findings in a relevant medical journal. Presenting the results in abstract form or as a poster in an appropriate medical congress may also be desirable.

Conditions

• Hypothermia

Interventions

Type	Name	Description
OTHER	Hibler's	Passive body heat retention using multiple-layer tight wrapping of patient
OTHER	Warm Air	Active, convective warming of patient using warm air blanket

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-02-12
• Completion: 2019-02-12
• First posted: 2016-11-29
• Last updated: 2021-03-01

Locations

1 site across 1 country: Malawi