Tourniquet Safety and EffectivenessNCT02620722
A New Technique for Determining Limb Occlusion Pressure
A study testing Personalized Tourniquet Instrument and Handheld Doppler ultrasound in people with Tourniquet Safety and Effectiveness, run by University of British Columbia at 4 sites in Canada.
Trial summary
This study evaluates a novel technique for measuring the minimum pressure necessary to achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP). Patients will have tourniquets applied to their arms and legs and LOP will be measured using the new technique and a gold standard Doppler… Read more about this study
- Who is it for?
- Ages 3 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourniquet Safety and Effectiveness
- What is being tested?
- Personalized Tourniquet Instrument and Handheld Doppler ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 4 sitesCanada
- Study dates
- Sep 2014to Dec 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 3 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Scheduled for a visit to one of four surgical clinics in Vancouver, Canada
- Agreed to participate in the study and provide informed consent
Who cannot join
- Unable to give informed consent on their own behalf or by a legal guardian
- Lack of parental agreement in the case of consent from a legally competent minor
- Standard contraindications to tourniquet use
- Vascular disease or circulation problems in the extremities
- History or indication of deep vein thrombosis
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Complex Joint Clinic, Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Cambie Surgery Centre
Vancouver, British Columbia, V5Z 3C6
Foot and Ankle Clinic, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
BC Children's and Women's Hospital
Vancouver, British Columbia
About this study
This study evaluates a novel technique for measuring the minimum pressure necessary to achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP). Patients will have tourniquets applied to their arms and legs and LOP will be measured using the new technique and a gold standard Doppler ultrasound technique.
Read the detailed description
Optimal tourniquet safety depends on accurately determining the minimum pressure necessary to achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP). However, LOP is not yet routinely measured in all patients due to limitations of current techniques. This study evaluates a novel technique for measuring the LOP through the tourniquet cuff that overcomes many limitations of current LOP measurement techniques.
The goal of the study is to determine if the LOP measured by the new technique is statistically or clinically different from the LOP measured by a gold standard Doppler ultrasound technique in adult and pediatric patients
- Conditions
- Tourniquet Safety and Effectiveness
- Being tested
- Personalized Tourniquet Instrument, Handheld Doppler ultrasound
- Keywords
- tourniquet, safety, personalized, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Tourniquet InstrumentDevice
Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument.
Handheld Doppler ultrasoundDevice
Measure the limb occlusion pressure in each patient using the gold-standard technique with the Doppler ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| LOP Measurement | Experimental | Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument and the gold-standard technique with the handheld Doppler ultrasound. Receives: Device: Personalized Tourniquet Instrument; Device: Handheld Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Occlusion Pressure Measurement (mmHg) using the new technique and the gold-standard technique
Measured: at time of measurement
Secondary outcomes (1)
Limb Occlusion Pressure Measurement (mmHg) using the new technique and the existing distal sensor-based technique
Measured: at time of measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourniquet Safety and EffectivenessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James A. McEwen, University of British Columbia
- Investigators
- James A McEwen, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620722
- Sponsor's protocol ID
- H14-02048
- Status last verified
- Nov 2020
- First submitted
- 1 Dec 2015
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.
PubMed 19952261
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Technique for Determining Limb Occlusion Pressure
- ClinicalTrials.gov ID
- NCT02620722
- Acronym / sponsor ID
- H14-02048
- Conditions
- Tourniquet Safety and Effectiveness
- Keywords
- tourniquet, safety, personalized, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 3 Dec 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.
This study evaluates a novel technique for measuring the minimum pressure necessary to achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP). Patients will have tourniquets applied to their arms and legs and LOP will be measured using the new technique and a gold standard Doppler ultrasound technique.
Detailed description
Optimal tourniquet safety depends on accurately determining the minimum pressure necessary to achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP). However, LOP is not yet routinely measured in all patients due to limitations of current techniques. This study evaluates a novel technique for measuring the LOP through the tourniquet cuff that overcomes many limitations of current LOP measurement techniques.
The goal of the study is to determine if the LOP measured by the new technique is statistically or clinically different from the LOP measured by a gold standard Doppler ultrasound technique in adult and pediatric patients
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LOP Measurement | Experimental | Device: Personalized Tourniquet Instrument, Device: Handheld Doppler ultrasoundMeasure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument and the gold-standard technique with the handheld Doppler ultrasound. |
Who may qualify
- Ages
- 3 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for a visit to one of four surgical clinics in Vancouver, Canada
- Agreed to participate in the study and provide informed consent
Key exclusion criteria (5 listed)
- Unable to give informed consent on their own behalf or by a legal guardian
- Lack of parental agreement in the case of consent from a legally competent minor
- Standard contraindications to tourniquet use
- Vascular disease or circulation problems in the extremities
- History or indication of deep vein thrombosis
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 |
|---|---|---|
| Personalized Tourniquet InstrumentMeasure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument. | Device | LOP Measurement |
| Handheld Doppler ultrasoundMeasure the limb occlusion pressure in each patient using the gold-standard technique with the Doppler ultrasound. | Device | LOP Measurement |
Primary outcome
Limb Occlusion Pressure Measurement (mmHg) using the new technique and the gold-standard technique
Time frame: at time of measurement
1 secondary outcome
Limb Occlusion Pressure Measurement (mmHg) using the new technique and the existing distal sensor-based technique
Time frame: at time of measurement
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 3 Nov 2020.
- Background: PubMed 19952261Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.
- Educational website about tourniquetsLink provided by the sponsor.
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Recruiting
Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT
Major Depressive Disorder, Bipolar Disorder
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.
James A McEwen, PhD principal investigator
University of British Columbia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Tourniquet Instrument and Handheld Doppler ultrasound in people with Tourniquet Safety and Effectiveness, run by University of British Columbia at 4 sites 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 5 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Limb Occlusion Pressure Measurement (mmHg) using the new technique and the gold-standard technique (time frame: at time of measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02620722, which also lists 1 linked publication.
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 3 Nov 2020.