ShiveringNCT02436174
Assessment Of Shivering With iSeismograph
An observational study of Shivering, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shivering
- What is being tested?
- novel device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Oct 2016
- Phase
- Observational
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women
Who may be able to join
- pregnancy
- epidural in situ
Who cannot join
- non-cesarean delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This novel method will allow the investigators to quantitatively assess and measure shivering in obstetric parturients undergoing varying procedures under epidural anesthesia.
- Conditions
- Shivering
- Being tested
- novel device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel deviceDevice
novel device being used to measure shivering
| Study group | Role | What they receive |
|---|---|---|
| study group | patients undergoing cesarean under epidural anesthesia Receives: Device: novel device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShiveringStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Massey, MD FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436174
- Sponsor's protocol ID
- H14-02480
- Status last verified
- Feb 2017
- First submitted
- 31 Mar 2015
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Shivering With iSeismograph In Parturients Undergoing Surgical Procedures Under Epidural Anesthesia
- ClinicalTrials.gov ID
- NCT02436174
- Acronym / sponsor ID
- H14-02480
- Conditions
- Shivering
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 May 2015 (estimated)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Device: novel devicepatients undergoing cesarean under epidural anesthesia |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (2 listed)
- pregnancy
- epidural in situ
Key exclusion criteria (1 listed)
- non-cesarean delivery
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 |
|---|---|---|
| novel devicenovel device being used to measure shivering | Device | study group |
Primary outcome
Comparison between physician-reported shivering and measured shivering
Time frame: During cesarean delivery
Quantifiable assessment of shivering data measured by novel device will be compared to subjective assessment of shivering made by attending anesthesiologist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
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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.
Simon Massey, MD FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shivering, run by University of British Columbia at 1 site in Canada.
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 1 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: finished, as of the sponsor's last update on 1 Mar 2017. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between physician-reported shivering and measured shivering (time frame: During cesarean delivery). 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 1 Mar 2017.