Anesthesia, EpiduralNCT03503656
"Compuflo®" in Epidural Space Identification
An observational study of Anesthesia, Epidural and Analgesia, Epidural, run by Azienda Ospedaliero-Universitaria Careggi.
Trial summary
Recently a computerized injection pump has been programmed with its own mathematical algorithm to measure on a digital display the pressure trend in the form of a continuous curve and it has been connected to an acoustic device that emits a sound at increasing frequencies during the progress of the epidural needle… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anesthesia, Epidural, Analgesia, Epidural
- What is being tested?
- epidural catheter placement
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All the consecutive patients in gynecological and obstetric setting of a tertiary referral University Hospital submitted to epidural catheter insertion with CompuFlo® System
Who may be able to join
- signed informed consent to procedure more than 18 years of age
Who cannot join
- NO
About this study
Official title: Evaluation and Usability of "Compuflo®" in Epidural Anesthesia for Obstetric and Gynecological Areas
Recently a computerized injection pump has been programmed with its own mathematical algorithm to measure on a digital display the pressure trend in the form of a continuous curve and it has been connected to an acoustic device that emits a sound at increasing frequencies during the progress of the epidural needle (Compuflo®, Milestone Scientific, Livingston, NJ); it has therefore been made capable of controlling the pressure at the injection point and adjusting the infusion rate according to a predetermined maximum value using the registered Dynamic Pressure Sensing (DPS) technology.
The Compuflo® system guarantees feedback on simultaneous and continuous pressure data, both visual and auditory, identifying and differentiating the different types of tissue. This safe and effective feedback helps medical personnel to identify the epidural space with greater accuracy and alerts them if the needle moves into the identified position.
Read more
The aim of the study was to verify the efficacy and usability of the Compuflo® system in a clinical setting.
The setting was the area of gynecology and obstetrics at a tertiary referral level University Hospital.
All the consecutive patients undergoing to an epidural catheter placement with Compuflo® were collected until to a sample size of 140 patients.
Primary endpoint was the number and percentage of successes in the placement of epidural catheters with Compuflo® Epidural. Secondary endpoints were: the number and percentage of accidental dural punctures during epidural catheter placement; the number of attempts aimed at the correct positioning of the epidural catheter; the measurement of procedure time duration; the measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space; the measurement of volume of saline injected by Compuflo® to identify the epidural space.
- Conditions
- Anesthesia, Epidural, Analgesia, Epidural
- Being tested
- epidural catheter placement
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural catheter placementDevice
insertion of an epidural catheter using Compuflo System
| Study group | Role | What they receive |
|---|---|---|
| CompuFlo | All the consecutive patients undergoing to an epidural catheter placement in Gynecological and Obstetric setting Receives: Device: epidural catheter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
was the number of successes
number
Measured: 18 months
Secondary outcomes (5)
the number of accidental dural punctures
number
Measured: 18 months
the number of attempts
number
Measured: 18 months
procedure time duration
seconds
Measured: 18 months
measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space
mmHg
Measured: 18 months
measurement of volume of saline injected by Compuflo®
ml
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study startJan 2017
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, EpiduralStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Di Filippo, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503656
- Sponsor's protocol ID
- CompuFlo AOUCareggi
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Choi PT, Galinski SE, Takeuchi L, Lucas S, Tamayo C, Jadad AR. PDPH is a common complication of neuraxial blockade in parturients: a meta-analysis of obstetrical studies. Can J Anaesth. 2003 May;50(5):460-9. doi: 10.1007/BF03021057.
PubMed 12734154Lechner TJ, van Wijk MG, Maas AJ, van Dorsten FR, Drost RA, Langenberg CJ, Teunissen LJ, Cornelissen PH, van Niekerk J. Clinical results with the acoustic puncture assist device, a new acoustic device to identify the epidural space. Anesth Analg. 2003 Apr;96(4):1183-1187. doi: 10.1213/01.ANE.0000052382.04446.42.
PubMed 12651681Ghelber O, Gebhard RE, Vora S, Hagberg CA, Szmuk P. Identification of the epidural space using pressure measurement with the compuflo injection pump--a pilot study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):346-52. doi: 10.1016/j.rapm.2008.01.012.
PubMed 18675746
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Usability of "Compuflo®" in Epidural Anesthesia for Obstetric and Gynecological Areas
- ClinicalTrials.gov ID
- NCT03503656
- Acronym / sponsor ID
- CompuFlo AOUCareggi
- Conditions
- Anesthesia, Epidural, Analgesia, Epidural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 20 Apr 2018 (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.
Recently a computerized injection pump has been programmed with its own mathematical algorithm to measure on a digital display the pressure trend in the form of a continuous curve and it has been connected to an acoustic device that emits a sound at increasing frequencies during the progress of the epidural needle (Compuflo®, Milestone Scientific, Livingston, NJ); it has therefore been made capable of controlling the pressure at the injection point and adjusting the infusion rate according to a predetermined maximum value using the registered Dynamic Pressure Sensing (DPS) technology.
The Compuflo® system guarantees feedback on simultaneous and continuous pressure data, both visual and auditory, identifying and differentiating the different types of tissue. This safe and effective feedback helps medical personnel to identify the epidural space with greater accuracy and alerts them if the needle moves into the identified position.
The aim of the study was to verify the efficacy and usability of the Compuflo® system in a clinical setting.
The setting was the area of gynecology and obstetrics at a tertiary referral level University Hospital.
All the consecutive patients undergoing to an epidural catheter placement with Compuflo® were collected until to a sample size of 140 patients.
Primary endpoint was the number and percentage of successes in the placement of epidural catheters with Compuflo® Epidural. Secondary endpoints were: the number and percentage of accidental dural punctures during epidural catheter placement; the number of attempts aimed at the correct positioning of the epidural catheter; the measurement of procedure time duration; the measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space; the measurement of volume of saline injected by Compuflo® to identify the epidural space.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CompuFlo | – | Device: epidural catheter placementAll the consecutive patients undergoing to an epidural catheter placement in Gynecological and Obstetric setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the consecutive patients in gynecological and obstetric setting of a tertiary referral University Hospital submitted to epidural catheter insertion with CompuFlo® System
Key inclusion criteria (1 listed)
- signed informed consent to procedure more than 18 years of age
Key exclusion criteria (1 listed)
- NO
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 |
|---|---|---|
| epidural catheter placementinsertion of an epidural catheter using Compuflo System | Device | CompuFlo |
Primary outcome
was the number of successes
Time frame: 18 months
number
5 secondary outcomes
the number of accidental dural punctures
Time frame: 18 months
the number of attempts
Time frame: 18 months
procedure time duration
Time frame: 18 months
measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space
Time frame: 18 months
measurement of volume of saline injected by Compuflo®
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Background: PubMed 12734154Choi PT, Galinski SE, Takeuchi L, Lucas S, Tamayo C, Jadad AR. PDPH is a common complication of neuraxial blockade in parturients: a meta-analysis of obstetrical studies. Can J Anaesth. 2003 May;50(5):460-9. doi: 10.1007/BF03021057.
- Background: PubMed 12651681Lechner TJ, van Wijk MG, Maas AJ, van Dorsten FR, Drost RA, Langenberg CJ, Teunissen LJ, Cornelissen PH, van Niekerk J. Clinical results with the acoustic puncture assist device, a new acoustic device to identify the epidural space. Anesth Analg. 2003 Apr;96(4):1183-1187. doi: 10.1213/01.ANE.0000052382.04446.42.
- Background: PubMed 18675746Ghelber O, Gebhard RE, Vora S, Hagberg CA, Szmuk P. Identification of the epidural space using pressure measurement with the compuflo injection pump--a pilot study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):346-52. doi: 10.1016/j.rapm.2008.01.012.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Epidural and Analgesia, Epidural, run by Azienda Ospedaliero-Universitaria Careggi.
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: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
was the number of successes (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03503656, which also lists 3 linked publications.
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 20 Apr 2018.