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Preventing Inadvertent Hypothermia in Paediatric Neurosurgery in Malawi

2016-11-30 15:45:45 | BioPortfolio

Summary

We´re undertaking 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. Our control group will be heated actively with the use of warm-air blankets. Our aim 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.

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.

Our aim is to undertake a randomized controlled non-inferiority study in which we compare two different modalities to prevent inadvertent intraoperative hypothermia 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. In the study period we aim 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 introduced to the study. If consent (and assent, where applicable) is obtained they 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. We will also study a number of secondary end-points such as prevalence of shivering, conscious level, analgesia requirements, oxygenation and overall cost.

Upon completion of the study we will seek to publish our 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Hypothermia

Intervention

Hibler's, Warm Air

Location

Queen Elizabeth Central Hospital
Blantyre
Malawi

Status

Recruiting

Source

Oslo University Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-30T15:45:45-0500

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Medical and Biotech [MESH] Definitions

Abnormally low BODY TEMPERATURE that is intentionally induced in warm-blooded animals by artificial means. In humans, mild or moderate hypothermia has been used to reduce tissue damages, particularly after cardiac or spinal cord injuries and during subsequent surgeries.

Lower than normal body temperature, especially in warm-blooded animals; in man usually accidental or unintentional.

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