Hypothermia in Cesarean Sectio Patients in Regional Anaesthesia

November 2, 2018 updated by: Johan C Ræder, Oslo University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

consecutive, elective cesarean sectio

Description

Inclusion Criteria:

  • Elective patients
  • planned spinal anaesthesia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of perioperative hypothermia, less than 36.0 degrees
Time Frame: perioperatively
mesured by zero flux in forehead
perioperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction: Patient will be asked to grade
Time Frame: perioperatively, repeated
Patient will be asked to grade their feeling of being Cold/warm
perioperatively, repeated
duration of perioperative hypothermia
Time Frame: perioperatively, continously
number of minutes below 36.0 degrees
perioperatively, continously
shivering
Time Frame: perioperatively
any shivering due to being cold
perioperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2018

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (ACTUAL)

November 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hypothermia Sectio OUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Cesarean Section

Clinical Trials on zero flux skin termometer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe