NCT03730090

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

November 1, 2018

Last Update Submit

November 2, 2018

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • incidence of perioperative hypothermia, less than 36.0 degrees

    mesured by zero flux in forehead

    perioperatively

Secondary Outcomes (3)

  • patient satisfaction: Patient will be asked to grade

    perioperatively, repeated

  • duration of perioperative hypothermia

    perioperatively, continously

  • shivering

    perioperatively

Interventions

zero flux skin termometerDEVICE

Core temperature is monitored continously, non-invasively

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly female patients for sectio
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive, elective cesarean sectio

You may qualify if:

  • Elective patients
  • planned spinal anaesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 5, 2018

Study Start

November 1, 2018

Primary Completion

March 1, 2019

Study Completion

December 1, 2019

Last Updated

November 5, 2018

Record last verified: 2018-11