Blood Pressure MeasurementNexfin PilotNCT02447471
Agreement of the Nexfin™ Monitor With Non-invasive Blood Pressure Measurement
An observational study of Blood Pressure Measurement, run by University of British Columbia at 1 site in Canada.
Trial summary
Currently, BP is measured using an inflatable cuff wrapped around the patient's upper arm. This can be set to inflate every minute, but measurement may fail due to patient movement or shivering. Failed measurement occurs in up to 38% of patients. 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
- Blood Pressure Measurement
- What is being tested?
- Nexfin
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Jan 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: BC Women's hospital parturients
Who may be able to join
- Healthy female pregnant patients
- ≥19 years old
- Undergoing elective Cesarean section under spinal or combined spinal-epidural anesthesia
Who cannot join
- Contraindication to wearing Nexfin cuff (upper limb vascular disease, amputated digits)
- Obesity (BMI > 38 kg/m2)
- Use of arterial line for BP measurement
- Inability to read and understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Agreement of the Nexfin™ Non-invasive Cardiac Output Monitor With Non-invasive Blood Pressure Measurement in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: a Pilot Observational Study
Currently, BP is measured using an inflatable cuff wrapped around the patient's upper arm. This can be set to inflate every minute, but measurement may fail due to patient movement or shivering. Failed measurement occurs in up to 38% of patients.
This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.
Read the detailed description
This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.
- Conditions
- Blood Pressure Measurement
- Being tested
- Nexfin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexfinDevice
Nexfin cuff placed on finger to measure blood pressure
| Study group | Role | What they receive |
|---|---|---|
| study group | all participants Receives: Device: Nexfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nexfin bp vs NIBP
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 posted18 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure MeasurementStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vit Gunka, MD FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447471
- Sponsor's protocol ID
- H15-00992
- Acronym
- Nexfin Pilot
- Status last verified
- Jan 2016
- First submitted
- 14 May 2015
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement of the Nexfin™ Non-invasive Cardiac Output Monitor With Non-invasive Blood Pressure Measurement in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: a Pilot Observational Study
- ClinicalTrials.gov ID
- NCT02447471
- Acronym / sponsor ID
- Nexfin Pilot / H15-00992
- Conditions
- Blood Pressure Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 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.
Currently, BP is measured using an inflatable cuff wrapped around the patient's upper arm. This can be set to inflate every minute, but measurement may fail due to patient movement or shivering. Failed measurement occurs in up to 38% of patients.
This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.
Detailed description
This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Device: Nexfinall participants |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- BC Women's hospital parturients
Key inclusion criteria (3 listed)
- Healthy female pregnant patients
- ≥19 years old
- Undergoing elective Cesarean section under spinal or combined spinal-epidural anesthesia
Key exclusion criteria (4 listed)
- Contraindication to wearing Nexfin cuff (upper limb vascular disease, amputated digits)
- Obesity (BMI > 38 kg/m2)
- Use of arterial line for BP measurement
- Inability to read and understand English
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 |
|---|---|---|
| NexfinNexfin cuff placed on finger to measure blood pressure | Device | study group |
Primary outcome
Nexfin bp vs NIBP
Time frame: During cesarean delivery
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 26 Jan 2016.
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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.
Vit Gunka, 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 Blood Pressure Measurement, 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 3 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: finished, as of the sponsor's last update on 26 Jan 2016. 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?
Nexfin bp vs NIBP (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 26 Jan 2016.