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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thoracic Epidural Space Identification
• Intervention / Treatment: Procedure: Loss of resistance (LOR) technique; Device: CompuFlo® technology

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.

• Study Type: Interventional
• Enrollment (Estimated): 276
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgia Micha, Assistant Professor; Phone Number: +306974828254; Email: michageorgia@uoi.gr
• Study Contact Backup: Name: Mohamed Abdullah, MD; Phone Number: 2214 00302132051000; Email: mohammed12_90@yahoo.co.uk

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11521
      • "Elena Venizelou" General and Maternity Hospital of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

American Society of Anesthesiologists (ASA) Physical Status Classification System I-III Body mass index: 18 -35 kg/m2 Gynecological laparotomy with midline incision under general anesthesia and thoracic epidural analgesia

Exclusion Criteria:

Patients' denial to participate in the study ASA Physical Status Classification System >IV Contraindications to epidural analgesia Patients with sepsis Patients with pre-existing neurologic deficits Pre-existing operations in the thoracic spinal cord Emergency operations Patients with end-stage cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group LOR; The thoracic epidural space will be identified by the loss of resistance technique.	Procedure: Loss of resistance (LOR) technique; The thoracic epidural space will be identified by the loss of resistance (LOR) technique
Active Comparator: Group C; The thoracic epidural space will be identified by the CompuFlo® technology.	Device: CompuFlo® technology; The thoracic epidural space will be identified by the CompuFlo® technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of successful thoracic epidural space identification	The success of the thoracic epidural space identification	Loss of sensation to cold 20 min after the first dose administered through the epidural catheter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of successful thoracic epidural space identification by the first attempt	Percentage of successful thoracic epidural space identification by the first attempt	Loss of sensation to cold 20 min after the first dose administered through the epidural catheter during the first attempt
Number of attempts to successful thoracic epidural space identification	Number of attempts to successful thoracic epidural space identification	Number of attempts to successful thoracic epidural space identification up to a maximum of 3 adressed as loss of sensation to cold 20 min after the first dose administered through the epidural catheter
Time to identify the thoracic epidural space	Time to identify the thoracic epidural space	Time to insertion of epidural needle (Tuohy) in the supraspinous ligament to insertion of the epidural catheter
Adverse events	Adverse events (dural puncture, epidural hematoma, neurological deficit)	From epidural needle insertion up to 72 hours postoperatively

Collaborators and Investigators

• Sponsor: General and Maternity Hospital of Athens Elena Venizelou
• Investigators: Study Director: Konstantinos Stroumpoulis, PhD, General and Maternity Hospital of Athens Helena Venizelou

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: thoracic; epidural space; loss of resistance technique; CompuFlo® technology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting; Investigative Techniques; Methods
• Other Study ID Numbers: 21/03/2023/ID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes