Efficacy of CompuFlo® Technology in Thoracic Epidural Space Identification
- Conditions
- Thoracic Epidural Space Identification
- Interventions
- Device: CompuFlo® technologyProcedure: Loss of resistance (LOR) technique
- Registration Number
- NCT05798754
- Lead Sponsor
- General and Maternity Hospital of Athens Elena Venizelou
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 276
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C CompuFlo® technology The thoracic epidural space will be identified by the CompuFlo® technology. Group LOR Loss of resistance (LOR) technique The thoracic epidural space will be identified by the loss of resistance technique.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
Adverse events From epidural needle insertion up to 72 hours postoperatively Adverse events (dural puncture, epidural hematoma, neurological deficit)
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
Trial Locations
- Locations (1)
"Elena Venizelou" General and Maternity Hospital of Athens
🇬🇷Athens, Attica, Greece