Hand Injuries Clinical Trial
Official title:
A Prospective, Double-blinded, Randomized Controlled Trial Evaluating Effectiveness of Lower Tourniquet Pressures in Hand Surgery
NCT number | NCT04994405 |
Other study ID # | 21-00267 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 15, 2022 |
Est. completion date | December 2024 |
Verified date | May 2024 |
Source | NYU Langone Health |
Contact | Ali Azad |
Phone | 929-455-2600 |
Ali.azad[@]nyulangone.org | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Adult patient age 18 or older - Undergoing hand or upper extremity procedure - Tourniquet is used for procedure - Willingness and ability to consent Exclusion Criteria: - Individuals with procedures that are over 120 minutes in length |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Brooklyn | Brooklyn | New York |
United States | NYU Langone Orthopedic Center | New York | New York |
United States | NYU Langone Orthopedic Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Immediately After surgery in recovery room time | |
Secondary | 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. | Immediately After surgery in recovery room time |
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