Efficacy of CompuFlo® Technology in Thoracic Epidural Space Identification

• Sponsor: General and Maternity Hospital of Athens Elena Venizelou (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05798754
• Collaborator: (none)
• Enrollment: 276
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 12

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Epidural Space Identification	Procedure: Loss of resistance (LOR) technique; Device: CompuFlo® technology	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 276 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective blind, non-inferiority randomized trialProspective blind, non-inferiority randomized trial
• Masking: Single (Outcomes Assessor)
• Masking Description: Member of the study group that assesses the epidural's success
• Primary Purpose: Diagnostic
• Official Title: Correlation of Standard Loss of Resistance Technique Versus the CompuFlo®-Assisted Technology for Thoracic Epidural Space Identification
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of successful thoracic epidural space identification [Loss of sensation to cold 20 min after the first dose administered through the epidural catheter]

   The success of the thoracic epidural space identification

Secondary Outcome Measures

1. 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]

   Percentage of successful thoracic epidural space identification by the first attempt

2. 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]

   Number of attempts to successful thoracic epidural space identification

3. Time to identify the thoracic epidural space [Time to insertion of epidural needle (Tuohy) in the supraspinous ligament to insertion of the epidural catheter]

   Time to identify the thoracic epidural space

4. Adverse events [From epidural needle insertion up to 72 hours postoperatively]

   Adverse events (dural puncture, epidural hematoma, neurological deficit)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"Elena Venizelou" General and Maternity Hospital of Athens	Athens	Attica	Greece	11521

Sponsors and Collaborators

• General and Maternity Hospital of Athens Elena Venizelou

Investigators

• Study Director: Konstantinos Stroumpoulis, PhD, General and Maternity Hopsital of Athens Helena Venizelou

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: General and Maternity Hospital of Athens Elena Venizelou
• ClinicalTrials.gov Identifier: NCT05798754
• Other Study ID Numbers: 21/03/2023/ID
• First Posted: Apr 5, 2023
• Last Update Posted: Apr 5, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by General and Maternity Hospital of Athens Elena Venizelou: thoracic; epidural space; loss of resistance technique; CompuFlo® technology
• Additional relevant MeSH terms: Aneurysm, Dissecting

Study Results

No Results Posted as of Apr 5, 2023