Lower Tourniquet Pressure Study

NCT04994405 | Completed DMC

• 1 other identifier: 21-00267
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hand Injuries; Upper Extremity Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of lower tourniquet pressures based on SBP on post-operative tourniquet site pain

  Immediately After surgery in recovery room time

Study Arms (2)

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).

Procedure: Tourniquet Pressure

Interventions

Tourniquet Pressure PROCEDURE

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.

Lower Tiered Pressures

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient age 18 or older
• Undergoing hand or upper extremity procedure
• Tourniquet is used for procedure
• Willingness and ability to consent

You may not qualify if:

• Individuals with procedures that are over 120 minutes in length

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (3)

NYU Langone Brooklyn

Brooklyn, New York, 11220, United States

Location

NYU Langone Orthopedic Hospital

New York, New York, 10010, United States

Location

NYU Langone Orthopedic Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hand Injuries; Arm Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Ali Azad

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 6, 2021
• Study Start: July 15, 2022
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to ali.azad@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (3)