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Preventing Inadvertent Hypothermia in Paediatric Neurosurgery in Malawi

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ClinicalTrials.gov Identifier: NCT02975817
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
University of Malawi College of Medicine
Information provided by (Responsible Party):
Anders Christian Feyling, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Hypothermia Other: Hibler's Other: Warm Air Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Inadvertent Hypothermia in Children Undergoing Elective Neurosurgery in Malawi - a Prospective Randomized Clinical Trial
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Hibler's
Insert description from protocol
Other: Hibler's
Passive body heat retention using multiple-layer tight wrapping of patient

Active Comparator: Warm Air
Insert description from protocol
Other: Warm Air
Active, convective warming of patient using warm air blanket




Primary Outcome Measures :
  1. incidence of hypothermia [ Time Frame: from start of surgery till end of surgery ]
    incidence of core temperatures below 36,0 C


Secondary Outcome Measures :
  1. incidence of postoperative shivering [ Time Frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay ]
    incidence of shivering at arrival at and at the end of the fifth hour of stay in HDU

  2. Oxygen requirements [ Time Frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay ]
    requirement of supplemental oxygen (and mode of delivery) to maintain peripheral oxygen saturation at 95% or above

  3. Degree of alertness [ Time Frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay ]
    Degree of alertness (as judged using a simple 5 step scale) at arrival at and at the end of the fifth hour of stay in HDU

  4. Proportion of surgery time spent normothermic [ Time Frame: from start of surgery till end of surgery ]
    proportion of surgery time spent at core temperature at or above 36,0 C



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Ages Eligible for Study:   up to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975817


Contacts
Contact: Anders C Feyling, MD +4792208111 anders.feyling@gmail.com
Contact: Aina SK Zsidek, MD +4793253985 aina.zsidek@gmail.com

Locations
Malawi
Queen Elizabeth Central Hospital Recruiting
Blantyre, Malawi
Contact: Samson Mndolo, MD    +265888551851    kwazizira@gmail.com   
Contact: Priscilla Moyo, ACO    +265993041116    priscmoyo@gmail.com   
Sponsors and Collaborators
Oslo University Hospital
University of Malawi College of Medicine
Investigators
Principal Investigator: Anders C Feyling, MD Oslo University Hospital

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
assent form  This link exits the ClinicalTrials.gov site
Assent form
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Data sheets comprised of Front Sheet, CRF 1, CRF 2 and CRF 3

Responsible Party: Anders Christian Feyling, Principal investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02975817     History of Changes
Other Study ID Numbers: hypomalawi
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Anders Christian Feyling, Oslo University Hospital:
pediatric, intraoperative, neurosurgery, inadvertent

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms