- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02975817
Preventing Inadvertent Hypothermia in Paediatric Neurosurgery in Malawi
Preventing Inadvertent Hypothermia in Children Undergoing Elective Neurosurgery in Malawi - a Prospective Randomized Clinical Trial
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Blantyre, Malawi
- Queen Elizabeth Central Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hibler's
Insert description from protocol
|
Passive body heat retention using multiple-layer tight wrapping of patient
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Active Comparator: Warm Air
Insert description from protocol
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Active, convective warming of patient using warm air blanket
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of hypothermia
Time Frame: from start of surgery till end of surgery
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incidence of core temperatures below 36,0 C
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from start of surgery till end of surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of postoperative shivering
Time Frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay
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incidence of shivering at arrival at and at the end of the fifth hour of stay in HDU
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postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay
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Oxygen requirements
Time Frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay
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requirement of supplemental oxygen (and mode of delivery) to maintain peripheral oxygen saturation at 95% or above
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postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay
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Degree of alertness
Time Frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay
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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
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postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay
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Proportion of surgery time spent normothermic
Time Frame: from start of surgery till end of surgery
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proportion of surgery time spent at core temperature at or above 36,0 C
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from start of surgery till end of surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anders C Feyling, MD, Oslo University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- hypomalawi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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