NCT02436174

Brief Summary

Shivering is a common side-effect of epidural anesthesia. In studies to date, the assessment of shivering has been based on a simple scale using descriptive words rather than actual measurements. We believe that we can assess shivering more scientifically by using a novel method to quantify arm movements during shivering.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

March 31, 2015

Last Update Submit

February 28, 2017

Conditions

Shivering

Outcome Measures

Primary Outcomes (1)

  • Comparison between physician-reported shivering and measured shivering

    Quantifiable assessment of shivering data measured by novel device will be compared to subjective assessment of shivering made by attending anesthesiologist

    During cesarean delivery

Study Arms (1)

study group

patients undergoing cesarean under epidural anesthesia

Device: novel device

Interventions

novel deviceDEVICE

novel device being used to measure shivering

study group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • pregnancy
  • epidural in situ

You may not qualify if:

  • non-cesarean delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Study Officials

  • Simon Massey, MD FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

May 6, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

October 1, 2016

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

CA(1)