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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source NYU Langone Health
Contact Ali Azad
Phone 929-455-2600
Email Ali.azad@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Tourniquet Pressure
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

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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