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Hypothermia in Cesarean Sectio Patients in Regional Anaesthesia

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. Identifier: NCT03730090
Recruitment Status : Not yet recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Information provided by (Responsible Party):
Johan C Ræder, Oslo University Hospital

Brief Summary:

To study the core temperature perioperatively in patients due for elective cesarean sectio in spinal anaesthesia.

Core temperature will be registered by a zero-flux (SpotOn. 3m) probe on the forehead, starting in the holding area and continued until normotemperature post-operatively.

Condition or disease Intervention/treatment
Cesarean Section Device: zero flux skin termometer

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hypothermia in Cesarean Sectio Patients in Regional Anaesthesia
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Intervention Details:
  • Device: zero flux skin termometer
    Core temperature is monitored continously, non-invasively

Primary Outcome Measures :
  1. incidence of perioperative hypothermia, less than 36.0 degrees [ Time Frame: perioperatively ]
    mesured by zero flux in forehead

Secondary Outcome Measures :
  1. patient satisfaction: Patient will be asked to grade [ Time Frame: perioperatively, repeated ]
    Patient will be asked to grade their feeling of being Cold/warm

  2. duration of perioperative hypothermia [ Time Frame: perioperatively, continously ]
    number of minutes below 36.0 degrees

  3. shivering [ Time Frame: perioperatively ]
    any shivering due to being cold

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only female patients for sectio
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
consecutive, elective cesarean sectio

Inclusion Criteria:

  • Elective patients
  • planned spinal anaesthesia

Exclusion Criteria:

  • Conversion of procedure to general anaesthesia
  • allergy to temperature probe (adhesive)

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Responsible Party: Johan C Ræder, Professor, Oslo University Hospital Identifier: NCT03730090     History of Changes
Other Study ID Numbers: Hypothermia Sectio OUS
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Temperature Changes
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs