Cerebral AngiographySHIVERSNCT03566628
Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography
A study testing Warmed Isotonic Saline and Room-Temperature Isotonic Saline in people with Cerebral Angiography and Shivering, run by Universidad de Valparaiso at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Angiography, Shivering
- What is being tested?
- Warmed Isotonic Saline and Room-Temperature Isotonic Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChile
- Study dates
- 1 Feb 2019to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving TIVA
- Patients undergoing cerebral angiography
Who cannot join
- Glasgow Coma Scale <15 points prior to procedure
- Expected need of mechanical ventilation after procedure completion
- Use of sedatives
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Carlos Van Buren
Valparaíso, 2341131
Nathalie Lopez, M.D., 2364000, nathalielopez.jq@gmail.com
Alvaro Silva, M.D., 2364000, alvarosilvariquelme@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Angiography, Shivering
- Being tested
- Warmed Isotonic Saline, Room-Temperature Isotonic Saline
- Keywords
- Cerebral Angiography, Shivering, Anaesthesia, Warmed solutions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warmed Isotonic SalineOther
Isotonic saline warmed to 39ºC.
Room-Temperature Isotonic SalineOther
Isotonic saline at room temperature
| Study group | Role | What they receive |
|---|---|---|
| Warmed Saline | Experimental | 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. Receives: Other: Warmed Isotonic Saline |
| Room-Temperature Saline | Active comparator | 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. Receives: Other: Room-Temperature Isotonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 60 minutes
Secondary outcomes (1)
Shivering severity
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 Feb 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AngiographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Carlos Van Buren
- Responsible party
- Principal investigator, Nathalie Lopez, Universidad de Valparaiso
- Investigators
- Nathalie Lopez, MD, Study director, Hospital Carlos Van BurenAlvaro Silva, MD, Principal investigator, Universidad de ValparaisoFelipe Martinez, M.D; M.Sc., Principal investigator, Universidad Nacional Andres Bello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566628
- Sponsor's protocol ID
- UV-002
- Acronym
- SHIVERS
- Status last verified
- Jan 2019
- First submitted
- 27 May 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography: A Randomised Trial
- ClinicalTrials.gov ID
- NCT03566628
- Acronym / sponsor ID
- SHIVERS / UV-002
- Conditions
- Cerebral Angiography, Shivering
- Keywords
- Cerebral Angiography, Shivering, Anaesthesia, Warmed solutions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Collaborators
- Hospital Carlos Van Buren
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warmed Saline | Experimental | Other: Warmed Isotonic SalinePatients 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 comparator | Other: Room-Temperature Isotonic SalinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving TIVA
- Patients undergoing cerebral angiography
Key exclusion criteria (4 listed)
- Glasgow Coma Scale <15 points prior to procedure
- Expected need of mechanical ventilation after procedure completion
- Use of sedatives
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warmed Isotonic SalineIsotonic saline warmed to 39ºC. | Other | Warmed Saline |
| Room-Temperature Isotonic SalineIsotonic saline at room temperature | Other | Room-Temperature Saline |
Primary outcome
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.
1 secondary outcome
Shivering severity
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Lopez, MD study director
Hospital Carlos Van Buren
Alvaro Silva, MD principal investigator
Universidad de Valparaiso
Felipe Martinez, M.D; M.Sc. principal investigator
Universidad Nacional Andres Bello
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warmed Isotonic Saline and Room-Temperature Isotonic Saline in people with Cerebral Angiography and Shivering, run by Universidad de Valparaiso at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Lopez, MD (2364000, nathalielopez.jq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprocedural Shivering (time frame: up to 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.