NCT04994405

Lower Tourniquet Pressure Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hand Injuries
• Upper Extremity Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-15
• Primary completion: 2024-09-27
• Completion: 2024-09-27
• First posted: 2021-08-06
• Last updated: 2025-04-01

Locations

3 sites across 1 country: United States