Evaluation of a novel tourniquet for civil use

Not Applicable

• Conditions: S49; R58; S45.9; Other and unspecified injuries of shoulder and upper arm; Haemorrhage, not elsewhere classified; Injury of unspecified blood vessel at shoulder and upper arm level

• Registration Number: DRKS00025034
• Lead Sponsor: niversitätsklinikum HeidelbergKlinik für Anästhestiologie

Brief Summary

Introduction and aim: Severe external hemorrhage is a significant reason for morbidity and mortality in adults; thus, the swift and correct application of a tourniquet by laypersons can be lifesaving. We conducted this randomized-controlled cross-over study to investigate the use of a novel tourniquet. Methods: Participants were recruited at the Heidelberg University Hospital. Eligible participants were = 18 years old with a medical background but without prior experience in applying a tourniquet. Participants were 1:1 ran- domized to the intervention group (PAX tourniquet) or the control group (SAM or CAT tourniquet). In the control group, participants underwent another randomization to either the SAM or CAT tourniquet without a predefined allocation ratio. Hyperspectral measurements were undertaken (i) before ligation, (ii) 30 s after ligation, and (iii) 30 s after the reopening of the tourniquet. The primary outcome was time until ligation before crossover between the respective groups. The analysis of secondary endpoints included all attempts to assess a possible learning ef- fect, intraoperator variability, and hyperspectral measurements. Participants were crossed to the other study group after a brief wash-out phase. Results: In total, 50 participants were recruited, resulting in 100 attempts. A success rate of 98% was observed across the study population. Time until ligation was 49 s and 56 s (p = 0.572) in the intervention and control group, respectively. However, there was a significant difference between the PAX and SAM (54 vs 75 s; p = 0.037) and the SAM and CAT tourniquet (75 vs. 47 s; p = 0.015). Further, we observed a significant learning effect in participants allocated to the control group first, with a median reduction of 9 s in the time until ligation. Hyperspectral measurements showed a significant decrease in perfusion and tissue oxygenation after ligation. Further, a significant increase in perfusion and tissue oxygenation was found after reopening the tourniquet com- pared to the baseline measurement. Conclusion: The novel PAX tourniquet can be applied quickly and effectively by medical personnel without prior experience in applying a tourniquet.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-13
• Study Completion: 2022-11-30
• Results First Posted: 2024-02-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

18 years
- Capable of giving consent

Exclusion Criteria

- Withdrawal from the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Does a tourniquet with a fixation option every 90° require less pressure to set compared to standard products with fixations every 180°?<br><br>Is there a difference in the time it takes for the products to effectively set?

Secondary Outcome Measures

Name	Time	Method
Does the setting pressure differ for different subjects?<br>What is the patient comfort like? <br>Are there increased user errors? <br>How do the users rate the products? <br>Can a successful ligation be detected by a pulse oximeter?