Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography (SHIVERS)

January 28, 2019 updated by: Nathalie Lopez, Universidad de Valparaiso

Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography: A Randomised Trial

This study evaluates whether the use of warmed solutions during cerebral angiography reduces the incidence of post-anaesthetic shivering. Half of participants will receive pre-warmed (39ºC) isotonic saline, while the other half receives the same solution at room temperature.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Shivering is a physiologic reaction aimed at raising body temperature that is very common amongst patients undergoing cerebral angiographies. The use of pre-warmed solutions during the procedure may reduce the incidence of shivering amongst these patients. In this triple-blind randomised trial, a consecutive sample of participants receiving total intravenous anaesthesia (TIVA) and undergoing cerebral angiography will be allocated to receive a warmed (39ºC) solution of up to 500cc of isotonic saline or the same solution, but at room temperature. Patients requiring sedation, those expected to require mechanical ventilation after the procedure, those with diminished consciousness (Glasgow Coma Scale <15 pts) and patients not wishing to participate will be excluded from the study. The primary endpoint for this study is the incidence of shivering up to 60 minutes after the procedure is completed. Shivering will be assessed using a validated scale by operators unaware of treament allocation. All analyses will be undertaken by a statistician that will not participate of the clinical assessment of included patients.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

All

Description

Inclusion Criteria:

  • Patients receiving TIVA
  • Patients undergoing cerebral angiography

Exclusion Criteria:

  • Glasgow Coma Scale <15 points prior to procedure
  • Expected need of mechanical ventilation after procedure completion
  • Use of sedatives
  • Refusal to participate

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Warmed Saline
Patients allocated to this arm will receive a warmed (39ºC) solution of up to 500mL of isotonic saline. This solution will be administered directly to the cerebral vasculature as part of the angiography.
Other: Warmed Isotonic Saline
Isotonic saline warmed to 39ºC.
Active Comparator: Room-Temperature Saline
Patients allocated to this arm will receive isotonic saline at room temperature. This solution will be administered directly to the cerebral vasculature as part of the angiography.
Other: Room-Temperature Isotonic Saline
Isotonic saline at room temperature

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprocedural Shivering
Time Frame: up to 60 minutes
Once the procedure is completed, the patient will be extubated and the presence or absence of shivering will be recorded up to 60 minutes after the extubation with the Badjatia 2008 scale consisting of a gradual evaluation of 0 to 3 points. With scores greater or equal to 1, shivering is considered established.
up to 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shivering severity
Time Frame: 60 minutes
The post operative shivering scale of Badjatia 2008 will be used. It consist of a gradual evaluation of 0 to 3 points, with 0 being the absence of shivering, 1 slight shivering, 2 moderate and 3 severe. The highest score obtained will be recorded within the measurements made every 5 minutes in the first 60 minutes after extubation.
60 minutes

Collaborators and Investigators

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

Sponsor

Universidad de Valparaiso

Collaborators

Hospital Carlos Van Buren

Investigators

  • Study Director: Nathalie Lopez, MD, Hospital Carlos Van Buren
  • Principal Investigator: Alvaro Silva, MD, Universidad de Valparaiso
  • Principal Investigator: Felipe Martinez, M.D; M.Sc., Universidad Andrés Bello

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)

February 1, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

May 27, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UV-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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 Shivering

Clinical Trials on Warmed Isotonic Saline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe