Efficacy of CompuFlo® Technology in Thoracic Epidural Space Identification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2025-03-31

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.

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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.

Conditions

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Thoracic Epidural Space Identification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective blind, non-inferiority randomized trial

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Member of the study group that assesses the epidural's success

Study Groups

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Group LOR

The thoracic epidural space will be identified by the loss of resistance technique.

Group Type ACTIVE_COMPARATOR

Loss of resistance (LOR) technique

Intervention Type PROCEDURE

The thoracic epidural space will be identified by the loss of resistance (LOR) technique

Group C

The thoracic epidural space will be identified by the CompuFlo® technology.

Group Type ACTIVE_COMPARATOR

CompuFlo® technology

Intervention Type DEVICE

The thoracic epidural space will be identified by the CompuFlo® technology

Interventions

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Loss of resistance (LOR) technique

The thoracic epidural space will be identified by the loss of resistance (LOR) technique

Intervention Type PROCEDURE

CompuFlo® technology

The thoracic epidural space will be identified by the CompuFlo® technology

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No