Hand InjuriesNCT04994405
Lower Tourniquet Pressure Study
A study testing Tourniquet Pressure in people with Hand Injuries and Upper Extremity Injury, run by NYU Langone Health at 3 sites in United States.
Trial summary
This study design is a prospective, double-blinded, randomized controlled trial evaluating the quality of bloodless surgical field with lower tourniquet pressures based on systolic blood pressure (SBP) compared to standard tourniquet pressures. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries, Upper Extremity Injury
- What is being tested?
- Tourniquet Pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jul 2022to 27 Sep 2024
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient age 18 or older
- Undergoing hand or upper extremity procedure
- Tourniquet is used for procedure
- Willingness and ability to consent
Who cannot join
- Individuals with procedures that are over 120 minutes in length
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NYU Langone Brooklyn
Brooklyn, New York, 11220
NYU Langone Orthopedic Hospital
New York, New York, 10010
NYU Langone Orthopedic Center
New York, New York, 10016
About this study
Official title: A Prospective, Double-blinded, Randomized Controlled Trial Evaluating Effectiveness of Lower Tourniquet Pressures in Hand Surgery
This study design is a prospective, double-blinded, randomized controlled trial evaluating the quality of bloodless surgical field with lower tourniquet pressures based on systolic blood pressure (SBP) compared to standard tourniquet pressures. A secondary goal is to evaluate the effect of lower tourniquet pressures on post-operative tourniquet site pain. The rationale behind the study is to provide evidence-based guidelines on tourniquet use to continue providing quality surgical care while minimizing pain and potential harm to patients.
Read the detailed description
Patients undergoing hand and upper extremity surgery at our institution will be offered participation in this study. Consenting patients will be randomized in a double-blinded fashion to either standard tourniquet pressure of 250 mmHg or lower tourniquet pressures based on SBP. Demographic data will be recorded as well as details of the surgical procedure. Post-operatively, the operating surgeon will complete a questionnaire about the quality of bloodless surgical field and the patient will complete a questionnaire about post-operative pain. This study will enroll approximately 150 patients. Statistical analysis will be completed to analyze the effectiveness of the intervention.
- Conditions
- Hand Injuries, Upper Extremity Injury
- Being tested
- Tourniquet Pressure
- Medical subject headings
- Hand Injuries, Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet PressureProcedure or surgery
The procedural intervention will be inflation of a pneumatic tourniquet to a lower than standard pressure as determined by the patient's SBP in hand and upper extremity surgery. The control will be inflation of a pneumatic tourniquet at a standard pressure of 250 mmHg in hand and upper extremity surgery.
The tourniquet used will be the standard tourniquet used for hand and upper extremity surgery at our institutions - a tourniquet 18 inches in length and 3 inches in width manufactured by Stryker (Kalamazoo, MI) used in conjunction with a protective sleeve matched to the size of the tourniquet cuff which is provided by the manufacturer. Both pieces are supplied in a sterile packaging. No other tourniquets will be used.
| Study group | Role | What they receive |
|---|---|---|
| Standard Pressure | No intervention | The extremity tourniquet used during hand surgery for these participants will be the standard pressure of 250 mmHg. |
| Lower Tiered Pressures | Experimental | The study intervention is the inflation of the extremity tourniquet to a pressure lower than the standard pressure of 250 mmHg during hand surgery for these participants determined by tiered guidelines based on systolic blood pressure (SBP). Receives: Procedure: Tourniquet Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of the bloodless surgical field provided by lower tourniquet pressures
Surgeon-completed questionnaire rating the quality of the bloodless operative field using a 4-point Likert scale ranging from 1 (excellent) meaning no blood in the surgical field to 4 (poor) meaning blood in the surgical field obscures view throughout the procedure. This survey will be completed immediately post-operatively.
Measured: Immediately After surgery in recovery room time
Secondary outcomes (1)
Effect of lower tourniquet pressures based on SBP on post-operative tourniquet site pain
Patient-completed questionnaire rating their tourniquet site pain post-operatively using the Visual Analogue Scale (VAS) ranging from 0 meaning no pain to 10 meaning worst possible pain. This survey will be completed post-operatively in the recovery unit.
Measured: Immediately After surgery in recovery room time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start15 Jul 2022
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Azad, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994405
- Sponsor's protocol ID
- 21-00267
- Status last verified
- Mar 2025
- First submitted
- 19 Jul 2021
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blinded, Randomized Controlled Trial Evaluating Effectiveness of Lower Tourniquet Pressures in Hand Surgery
- ClinicalTrials.gov ID
- NCT04994405
- Acronym / sponsor ID
- 21-00267
- Conditions
- Hand Injuries, Upper Extremity Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 6 Aug 2021 (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 design is a prospective, double-blinded, randomized controlled trial evaluating the quality of bloodless surgical field with lower tourniquet pressures based on systolic blood pressure (SBP) compared to standard tourniquet pressures. A secondary goal is to evaluate the effect of lower tourniquet pressures on post-operative tourniquet site pain. The rationale behind the study is to provide evidence-based guidelines on tourniquet use to continue providing quality surgical care while minimizing pain and potential harm to patients.
Detailed description
Patients undergoing hand and upper extremity surgery at our institution will be offered participation in this study. Consenting patients will be randomized in a double-blinded fashion to either standard tourniquet pressure of 250 mmHg or lower tourniquet pressures based on SBP. Demographic data will be recorded as well as details of the surgical procedure. Post-operatively, the operating surgeon will complete a questionnaire about the quality of bloodless surgical field and the patient will complete a questionnaire about post-operative pain. This study will enroll approximately 150 patients. Statistical analysis will be completed to analyze the effectiveness of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Pressure | No intervention | –The extremity tourniquet used during hand surgery for these participants will be the standard pressure of 250 mmHg. |
| Lower Tiered Pressures | Experimental | Procedure: Tourniquet PressureThe study intervention is the inflation of the extremity tourniquet to a pressure lower than the standard pressure of 250 mmHg during hand surgery for these participants determined by tiered guidelines based on systolic blood pressure (SBP). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient age 18 or older
- Undergoing hand or upper extremity procedure
- Tourniquet is used for procedure
- Willingness and ability to consent
Key exclusion criteria (1 listed)
- Individuals with procedures that are over 120 minutes in length
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 |
|---|---|---|
| Tourniquet PressureThe procedural intervention will be inflation of a pneumatic tourniquet to a lower than standard pressure as determined by the patient's SBP in hand and upper extremity surgery. The control will be inflation of a pneumatic tourniquet at a standard pressure of 250 mmHg in hand and upper extremity surgery. The tourniquet used will be the standard tourniquet used for hand and upper extremity surgery at our institutions - a tourniquet 18 inches in length and 3 inches in width manufactured by Stryker (Kalamazoo, MI) used in conjunction with a protective sleeve matched to the size of the tourniquet cuff which is provided by the manufacturer. Both pieces are supplied in a sterile packaging. No other tourniquets will be used. | Procedure or surgery | Lower Tiered Pressures |
Primary outcome
Quality of the bloodless surgical field provided by lower tourniquet pressures
Time frame: Immediately After surgery in recovery room time
Surgeon-completed questionnaire rating the quality of the bloodless operative field using a 4-point Likert scale ranging from 1 (excellent) meaning no blood in the surgical field to 4 (poor) meaning blood in the surgical field obscures view throughout the procedure. This survey will be completed immediately post-operatively.
1 secondary outcome
Effect of lower tourniquet pressures based on SBP on post-operative tourniquet site pain
Time frame: Immediately After surgery in recovery room time
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 Apr 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Ali Azad principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet Pressure in people with Hand Injuries and Upper Extremity Injury, run by NYU Langone Health at 3 sites in United States.
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 4 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 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Quality of the bloodless surgical field provided by lower tourniquet pressures (time frame: Immediately After surgery in recovery room time). 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 Apr 2025.