NCT05798754

Efficacy of CompuFlo® Technology in Thoracic Epidural Space Identification

Correlation of Standard Loss of Resistance Technique Versus the CompuFlo®-Assisted Technology for Thoracic Epidural Space Identification

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: General and Maternity Hospital of Athens Elena Venizelou · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this non inferiority trial is to assess the efficacy of CompuFlo® technology to identify the thoracic epidural space in relation to the gold standard loss of resistance technique.

Detailed description

This non inferiority trial shouts to adress whether the CompuFlo® technology to identify the thoracic epidural space is less efficacious to the gold standard loss of resistance technique (LOR). After informed signed consent patients that will be subjected to gynecological operations and meet the inclusion criteria will be eligible to participate. All operations will be performed under general anesthesia and thoracic epidural analgesia regardless of study arm. Patients will be randomly allocated into two study groups. In the first study group (Group LOR) the thoracic epidural space will be identified by the LOR technique and in the second study group (Group C) by the CompuFlo® technology. The primary outcome is the percentage of thoracic epidural space identification success in either study group.

Conditions

• Thoracic Epidural Space Identification

Interventions

Type	Name	Description
PROCEDURE	Loss of resistance (LOR) technique	The thoracic epidural space will be identified by the loss of resistance (LOR) technique
DEVICE	CompuFlo® technology	The thoracic epidural space will be identified by the CompuFlo® technology

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-01-01
• Completion: 2025-03-01
• First posted: 2023-04-05
• Last updated: 2023-04-05

Locations

1 site across 1 country: Greece

Regulatory

• FDA-regulated device study