Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography
SHIVERS
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2018
CompletedFirst Posted
Study publicly available on registry
June 25, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedJanuary 30, 2019
January 1, 2019
7 months
May 27, 2018
January 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postprocedural Shivering
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 Outcomes (1)
Shivering severity
60 minutes
Study Arms (2)
Warmed Saline
EXPERIMENTALPatients 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.
Room-Temperature Saline
ACTIVE COMPARATORPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients receiving TIVA
- Patients undergoing cerebral angiography
You may not qualify if:
- Glasgow Coma Scale \<15 points prior to procedure
- Expected need of mechanical ventilation after procedure completion
- Use of sedatives
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad de Valparaisolead
- Hospital Carlos Van Burencollaborator
Study Sites (1)
Hospital Carlos Van Buren
Valparaíso, 2341131, Chile
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 27, 2018
First Posted
June 25, 2018
Study Start
February 1, 2019
Primary Completion
September 1, 2019
Study Completion
November 1, 2019
Last Updated
January 30, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share