Clinical trial NCT05798754: Efficacy of CompuFlo® Technology in Thoracic Epidural Space Identification
Official title: Correlation of Standard Loss of Resistance Technique Versus the CompuFlo®-Assisted Technology for Thoracic Epidural Space Identification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Epidural Space Identification
Keywords: thoracic
epidural space
loss of resistance technique
CompuFlo® technology
Lead sponsor: General and Maternity Hospital of Athens Elena Venizelou
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective blind, non-inferiority randomized trial
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Percentage of successful thoracic epidural space identification
timeFrame: Loss of sensation to cold 20 min after the first dose administered through the epidural catheter
Secondary outcomes:
measure: Percentage of successful thoracic epidural space identification by the first attempt
timeFrame: Loss of sensation to cold 20 min after the first dose administered through the epidural catheter during the first attempt
measure: Number of attempts to successful thoracic epidural space identification
timeFrame: 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
measure: Time to identify the thoracic epidural space
timeFrame: Time to insertion of epidural needle (Tuohy) in the supraspinous ligament to insertion of the epidural catheter
measure: Adverse events
timeFrame: From epidural needle insertion up to 72 hours postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Elena Venizelou" General and Maternity Hospital of Athens
state: Attica
Study officials:
affiliation: General and Maternity Hopsital of Athens Helena Venizelou
name: Konstantinos Stroumpoulis, PhD
role: STUDY_DIRECTOR
References: