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NCT03730090 Clinical Trial

Hypothermia in Cesarean Sectio Patients in Regional Anaesthesia

Cesarean Section Clinical Trial

Official title:
Hypothermia in Cesarean Sectio Patients in Regional Anaesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03730090
Other study ID # Hypothermia Sectio OUS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2018
Est. completion date December 2019

Study information
Verified date November 2018
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date December 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Elective patients

- planned spinal anaesthesia

Exclusion Criteria:

- Conversion of procedure to general anaesthesia

- allergy to temperature probe (adhesive)

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of perioperative hypothermia, less than 36.0 degrees mesured by zero flux in forehead perioperatively
Secondary patient satisfaction: Patient will be asked to grade Patient will be asked to grade their feeling of being Cold/warm perioperatively, repeated
Secondary duration of perioperative hypothermia number of minutes below 36.0 degrees perioperatively, continously
Secondary shivering any shivering due to being cold perioperatively
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