Preventing Inadvertent Hypothermia in Paediatric Neurosurgery in Malawi
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02975817|
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia||Other: Hibler's Other: Warm Air||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
Insert description from protocol
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
- incidence of hypothermia [ Time Frame: from start of surgery till end of surgery ]incidence of core temperatures below 36,0 C
- 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
- 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
- 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
- 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
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
|Contact: Anders C Feyling, MDfirstname.lastname@example.org|
|Contact: Aina SK Zsidek, MDemail@example.com|
|Queen Elizabeth Central Hospital||Recruiting|
|Contact: Samson Mndolo, MD +265888551851 firstname.lastname@example.org|
|Contact: Priscilla Moyo, ACO +265993041116 email@example.com|
|Principal Investigator:||Anders C Feyling, MD||Oslo University Hospital|