<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02975817</url>
  </required_header>
  <id_info>
    <org_study_id>hypomalawi</org_study_id>
    <nct_id>NCT02975817</nct_id>
  </id_info>
  <brief_title>Preventing Inadvertent Hypothermia in Paediatric Neurosurgery in Malawi</brief_title>
  <official_title>Preventing Inadvertent Hypothermia in Children Undergoing Elective Neurosurgery in Malawi - a Prospective Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kamuzu University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators wish to undertake a randomized controlled non-inferiority trial to evaluate&#xD;
      the ability of a simple and low-cost method (Hibler´s method of wrapping the patient in&#xD;
      multiple insulating layers) to prevent intraoperative heat-loss in children undergoing&#xD;
      neurosurgery under anesthesia in Malawi. The control group will be heated actively with the&#xD;
      use of warm-air blankets. The aim of this study is to evaluate whether Hibler´s method can&#xD;
      provide a cheap and technically simple way of adequately preserving the patients´ core&#xD;
      temperature in the operating theatre in a resource-poor setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothermia in the perioperative setting is receiving increasing attention in anaesthetic and&#xD;
      surgical care. The paediatric age group is arguably at increased risk and thus deserves more&#xD;
      intensive focus.&#xD;
&#xD;
      The investigators wish to undertake a randomized controlled non-inferiority study in which&#xD;
      two different modalities for preventing inadvertent intraoperative hypothermia are compared.&#xD;
      The trial will be carried out in a paediatric neurosurgical population in a South-East&#xD;
      African regional tertiary care hospital.&#xD;
&#xD;
      The primary objective is to determine whether a low cost and simple method can be as&#xD;
      effective and safe as a more expensive and technically demanding method. The goal is to&#xD;
      recruit 40 patients in each of the two study arms. Patients younger than 12 years of age&#xD;
      presenting for scheduled neurosurgery will be approached and given information about the&#xD;
      study. If informed consent (and assent, where applicable) is obtained, participants will be&#xD;
      randomized to one of the two different techniques; either passive heat preservation using&#xD;
      what has become known as Hibler´s method (interventional group) or active warming with&#xD;
      warm-air blankets (control group). Throughout the study period core temperature will be&#xD;
      measured continuously, both for purposes of data accuracy and to maintain safety standards.&#xD;
&#xD;
      Primary study outcomes focus on the comparative ability of the methods in maintaining&#xD;
      acceptable core temperatures. The trial will also examine a number of secondary end-points&#xD;
      such as prevalence of shivering, conscious level, analgesia requirements, oxygenation and&#xD;
      overall cost.&#xD;
&#xD;
      Upon completion of the study the investigators will seek to publish the findings in a&#xD;
      relevant medical journal. Presenting the results in abstract form or as a poster in an&#xD;
      appropriate medical congress may also be desirable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">February 12, 2019</completion_date>
  <primary_completion_date type="Actual">February 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of hypothermia</measure>
    <time_frame>from start of surgery till end of surgery</time_frame>
    <description>incidence of core temperatures below 36,0 C</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of postoperative shivering</measure>
    <time_frame>postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay</time_frame>
    <description>incidence of shivering at arrival at and at the end of the fifth hour of stay in HDU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen requirements</measure>
    <time_frame>postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay</time_frame>
    <description>requirement of supplemental oxygen (and mode of delivery) to maintain peripheral oxygen saturation at 95% or above</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of alertness</measure>
    <time_frame>postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of surgery time spent normothermic</measure>
    <time_frame>from start of surgery till end of surgery</time_frame>
    <description>proportion of surgery time spent at core temperature at or above 36,0 C</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Hypothermia</condition>
  <arm_group>
    <arm_group_label>Hibler's</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insert description from protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Warm Air</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insert description from protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hibler's</intervention_name>
    <description>Passive body heat retention using multiple-layer tight wrapping of patient</description>
    <arm_group_label>Hibler's</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Warm Air</intervention_name>
    <description>Active, convective warming of patient using warm air blanket</description>
    <arm_group_label>Warm Air</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        I. Age under 12 years. II. Ensured bed in HDU for postoperative management. III. Undergoing&#xD;
        general anaesthesia with endotracheal intubation for planned cranial procedures; e.g.&#xD;
        craniotomies, ventriculo-peritoneal shunt placements, endoscopic third ventriculostomies&#xD;
        and similar procedures with a predominantly cranial access.&#xD;
&#xD;
        IV. Informed parental/guardian consent given&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        I. Pts. aged 12 years or older. II. Pts. with a temperature upon arrival at the anaesthetic&#xD;
        suite lower than 36,0 °C III. Pts. with a temperature upon arrival at the anaesthetic suite&#xD;
        greater than 37,5°C IV. Pts. judged to be unsuited for the standardized anaesthetic&#xD;
        technique chosen (due to known allergy, known or suspected difficult airway requiring other&#xD;
        anaesthetic interventions, cardiovascular conditions incompatible with the standard&#xD;
        anaesthetic agents or due to any other condition where the chosen technique is deemed&#xD;
        unsafe)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anders C Feyling, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth Central Hospital</name>
      <address>
        <city>Blantyre</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>February 24, 2021</last_update_submitted>
  <last_update_submitted_qc>February 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Anders Christian Feyling</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>pediatric, intraoperative, neurosurgery, inadvertent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02975817
org study id: hypomalawi
nct id: NCT02975817
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: incidence of hypothermia
time frame: from start of surgery till end of surgery
description: incidence of core temperatures below 36,0 C
measure: incidence of postoperative shivering
time frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay
description: incidence of shivering at arrival at and at the end of the fifth hour of stay in HDU
measure: Oxygen requirements
time frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay
description: requirement of supplemental oxygen (and mode of delivery) to maintain peripheral oxygen saturation at 95% or above
measure: Degree of alertness
time frame: postoperative period, from start of stay at HDU (High Dependency Unit) till 5 hours into this stay
description: 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
measure: Proportion of surgery time spent normothermic
time frame: from start of surgery till end of surgery
description: proportion of surgery time spent at core temperature at or above 36,0 C
arm group label: Hibler's
arm group type: Experimental
description: Insert description from protocol
arm group label: Warm Air
arm group type: Active Comparator
description: Insert description from protocol
intervention type: Other
intervention name: Hibler's
description: Passive body heat retention using multiple-layer tight wrapping of patient
arm group label: Hibler's
intervention type: Other
intervention name: Warm Air
description: Active, convective warming of patient using warm air blanket
arm group label: Warm Air
criteria: 
gender: All
minimum age: N/A
maximum age: 11 Years
healthy volunteers: No
last name: Anders C Feyling, MD
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
country: Malawi
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Anders Christian Feyling
investigator title: Principal investigator
mesh term: Hypothermia
sharing ipd: Undecided