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NCT Number: NCT05798754

Efficacy of CompuFlo® Technology in 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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

"Elena Venizelou" General and Maternity Hospital of Athens

Athens, Attica, 11521, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loss of resistance (LOR) technique

Procedure

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

CompuFlo® technology

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Percentage of successful thoracic epidural space identification by the first attempt

  2. 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

    Number of attempts to successful thoracic epidural space identification

  3. 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

    Time to identify the thoracic epidural space

  4. Adverse events

    Time frame: From epidural needle insertion up to 72 hours postoperatively

    Adverse events (dural puncture, epidural hematoma, neurological deficit)

Study contacts

Contact information is provided by the study sponsor or research team.

Georgia Micha, Assistant Professor

CONTACT

[email protected]

+306974828254

Mohamed Abdullah, MD

CONTACT

[email protected]

00302132051000 ext. 2214

Sponsors and collaborators

Lead sponsor

General and Maternity Hospital of Athens Elena Venizelou

Other

Registry information

Official study title

Correlation of Standard Loss of Resistance Technique Versus the CompuFlo®-Assisted Technology for Thoracic Epidural Space Identification

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Apr 5, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.