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Hypothermia in Cesarean Sectio Patients in Regional Anaesthesia

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ClinicalTrials.gov Identifier: NCT03730090
Recruitment Status : Not yet recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
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
Criteria

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
ClinicalTrials.gov 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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Hypothermia
Body Temperature Changes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs