Thoracic Epidural Space IdentificationNCT05798754
Efficacy of CompuFlo® Technology in Thoracic Epidural Space Identification
A study testing Loss of resistance (LOR) technique and CompuFlo® technology in people with Thoracic Epidural Space Identification, run by General and Maternity Hospital of Athens Elena Venizelou at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Thoracic Epidural Space Identification
- What is being tested?
- Loss of resistance (LOR) technique and CompuFlo® technology
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2027to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site
"Elena Venizelou" General and Maternity Hospital of Athens
Athens, Attica, 11521
About this study
Official title: Correlation of Standard Loss of Resistance Technique Versus the CompuFlo®-Assisted Technology for Thoracic Epidural Space Identification
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.
Read the 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.
- Conditions
- Thoracic Epidural Space Identification
- Being tested
- Loss of resistance (LOR) technique, CompuFlo® technology
- Keywords
- thoracic, epidural space, loss of resistance technique, CompuFlo® technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loss of resistance (LOR) techniqueProcedure or surgery
The thoracic epidural space will be identified by the loss of resistance (LOR) technique
CompuFlo® technologyDevice
The thoracic epidural space will be identified by the CompuFlo® technology
| Study group | Role | What they receive |
|---|---|---|
| Group LOR | Active comparator | The thoracic epidural space will be identified by the loss of resistance technique. Receives: Procedure: Loss of resistance (LOR) technique |
| Group C | Active comparator | The thoracic epidural space will be identified by the CompuFlo® technology. Receives: Device: CompuFlo® technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of successful thoracic epidural space identification
The success of the thoracic epidural space identification
Measured: Loss of sensation to cold 20 min after the first dose administered through the epidural catheter
Secondary outcomes (4)
Percentage of successful thoracic epidural space identification by the first attempt
Percentage of successful thoracic epidural space identification by the first attempt
Measured: 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
Measured: 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
Measured: 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)
Measured: From epidural needle insertion up to 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study startApr 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Epidural Space IdentificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective blind, non-inferiority randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General and Maternity Hospital of Athens Elena Venizelou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konstantinos Stroumpoulis, PhD, Study director, General and Maternity Hospital of Athens Helena Venizelou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798754
- Sponsor's protocol ID
- 21/03/2023/ID
- Status last verified
- Jun 2026
- First submitted
- 21 Mar 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Standard Loss of Resistance Technique Versus the CompuFlo®-Assisted Technology for Thoracic Epidural Space Identification
- ClinicalTrials.gov ID
- NCT05798754
- Acronym / sponsor ID
- 21/03/2023/ID
- Conditions
- Thoracic Epidural Space Identification
- Keywords
- thoracic, epidural space, loss of resistance technique, CompuFlo® technology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- General and Maternity Hospital of Athens Elena VenizelouUniversity, hospital or other
- Study start
- Apr 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective blind, non-inferiority randomized trial
| Arm | Type | Receives |
|---|---|---|
| Group LOR | Active comparator | Procedure: Loss of resistance (LOR) techniqueThe thoracic epidural space will be identified by the loss of resistance technique. |
| Group C | Active comparator | Device: CompuFlo® technologyThe thoracic epidural space will be identified by the CompuFlo® technology. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loss of resistance (LOR) techniqueThe thoracic epidural space will be identified by the loss of resistance (LOR) technique | Procedure or surgery | Group LOR |
| CompuFlo® technologyThe thoracic epidural space will be identified by the CompuFlo® technology | Device | Group C |
Primary outcome
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
The success of the thoracic epidural space identification
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Thoracic Epidural Space Identification
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Pectus Excavatum, Pain, Postoperative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Konstantinos Stroumpoulis, PhD study director
General and Maternity Hospital of Athens Helena Venizelou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loss of resistance (LOR) technique and CompuFlo® technology in people with Thoracic Epidural Space Identification, run by General and Maternity Hospital of Athens Elena Venizelou at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgia Micha, Assistant Professor (+306974828254, michageorgia@uoi.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.