Efficacy of CompuFlo® Technology in Thoracic Epidural Space Identification
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Loss of resistance (LOR) technique, CompuFlo® technology.
- Who it may be relevant to
- Registry conditions: Thoracic Epidural Space Identification. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Correlation of Standard Loss of Resistance Technique Versus the CompuFlo®-Assisted Technology for Thoracic Epidural Space Identification
Overview
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.
Interventions
- 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
Primary outcome measures
- Percentage of successful thoracic epidural space identification [Time frame: Loss of sensation to cold 20 min after the first dose administered through the epidural catheter]
Secondary outcome measures (4)
- Percentage of successful thoracic epidural space identification by the first attempt [Time frame: 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 [Time frame: 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 frame: Time to insertion of epidural needle (Tuohy) in the supraspinous ligament to insertion of the epidural catheter]
- Adverse events [Time frame: From epidural needle insertion up to 72 hours postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Greece · 1 center
- "Elena Venizelou" General and Maternity Hospital of Athens — Athens
Identifiers
NCT: NCT05798754 · 21/03/2023/ID