Lower Tourniquet Pressure Study

Hand Injuries Clinical Trial

Official title:

A Prospective, Double-blinded, Randomized Controlled Trial Evaluating Effectiveness of Lower Tourniquet Pressures in Hand Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994405
• Other study ID #: 21-00267
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: NYU Langone Health
• Contact: Ali Azad
• Phone: 929-455-2600
• Email: Ali.azad[@]nyulangone.org
• Is FDA regulated: No
• 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 2023
• Est. primary completion date: December 2023
• 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

Related Conditions & MeSH terms

• Arm Injuries
• Hand Injuries
• Upper Extremity Injury
• Wounds and Injuries

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