Preventing Inadvertent Hypothermia in Paediatric Neurosurgery in Malawi

NCT ID: NCT02975817

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-02-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Hibler's

Insert description from protocol

Group Type: EXPERIMENTAL

Hibler's

Intervention Type: OTHER

Passive body heat retention using multiple-layer tight wrapping of patient

Warm Air

Insert description from protocol

Group Type: ACTIVE_COMPARATOR

Warm Air

Intervention Type: OTHER

Active, convective warming of patient using warm air blanket

Interventions

Hibler's

Passive body heat retention using multiple-layer tight wrapping of patient

Intervention Type: OTHER

Warm Air

Active, convective warming of patient using warm air blanket

Intervention Type: OTHER

Eligibility 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)

• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kamuzu University of Health Sciences

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anders Christian Feyling

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anders C Feyling, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Queen Elizabeth Central Hospital

Blantyre, , Malawi

Countries

Malawi

References

Feyling AC, Kamalo PD, Hanche-Olsen T, Chikumbanje SS, Zsidek AS, Ponzi E, Raeder J. Preventing hypothermia in pediatric neurosurgery in Africa-A randomized controlled non-inferiority trial of insulation versus active warming. Acta Anaesthesiol Scand. 2024 Feb;68(2):167-177. doi: 10.1111/aas.14341. Epub 2023 Oct 26.

Reference Type: DERIVED

PMID: 37882145 (View on PubMed)

Other Identifiers

hypomalawi

Identifier Type: -

Identifier Source: org_study_id