Efficacy of CompuFlo® Technology in Thoracic Epidural Space Identification

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Thoracic Epidural Space Identification

Intervention / Treatment
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* Procedure: Loss of resistance (LOR) technique
* Device: CompuFlo® technology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective blind, non-inferiority randomized trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracic, epidural space, loss of resistance technique, CompuFlo® technology