Assessment Of Shivering With iSeismograph

Assessment Of Shivering With iSeismograph In Parturients Undergoing Surgical Procedures Under Epidural Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Shivering
• Intervention / Treatment: Device: novel device

Detailed Description

This novel method will allow the investigators to quantitatively assess and measure shivering in obstetric parturients undergoing varying procedures under epidural anesthesia.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • BC Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

Description

Inclusion Criteria:

• pregnancy
• epidural in situ

Exclusion Criteria:

• non-cesarean delivery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; patients undergoing cesarean under epidural anesthesia	Device: novel device; novel device being used to measure shivering

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Simon Massey, MD FRCPC, University of British Columbia

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: May 1, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: H14-02480