Lower Tourniquet Pressure Study

NYU Langone Health

Status: Completed

Conditions: Hand Injuries; Upper Extremity Injury

Treatments: Procedure: Tourniquet Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT04994405

21-00267

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 2 patient groups

Standard Pressure

No Intervention group

Description:

The extremity tourniquet used during hand surgery for these participants will be the standard pressure of 250 mmHg.

Lower Tiered Pressures

Experimental group

Description:

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).

Treatment:

Procedure: Tourniquet Pressure