AnesthesiaNCT04240197
Epidural Waveforms: Pressure Transducer vs CompuFlo
A study testing CompuFlo in people with Anesthesia, run by European e-Learning School in Obstetric Anesthesia at 1 site in Italy.
Trial summary
The purpose of this single arm, open label study will be to compare and evaluate the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space when compared to the standard pressure transducer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- CompuFlo
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2020to 30 Apr 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with an epidural lumbar catheter for anesthesia or analgesia
Who cannot join
- patients with malfunction or dislodgement of the epidural catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Pressure Waveform Analysis to Determine Correct Epidural Catheter Placement; a Comparison Between Pressure Transducer and the CompuFlo® CathCheck™ System
The purpose of this single arm, open label study will be to compare and evaluate the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space when compared to the standard pressure transducer.
Read the detailed description
40 patients who had an epidural functioning catheter previously positioned for anesthesia or analgesia will be enrolled. After removing the epidural filter and after having zeroed the instrument, the investigator will connect in a random fashion sequence, a standard pressure transducer attached to a standard invasive blood pressure monitor or to the CompuFlo CathCheck instrument to observe and record the occurrence of epidural pulsatile waveform.
The investigator will also note and evaluate:
The volume of saline priming necessary to obtain the waveform The effects of patient's position on the occurrence and amplitude of epidural pulsatile waveform
- Conditions
- Anesthesia
- Being tested
- CompuFlo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CompuFloDevice
Also called Standard Pressure Transducer
The occurrence of epidural pulse waves with CompuFlo and with standard pressure trnsducer
| Study group | Role | What they receive |
|---|---|---|
| Standard Pressure Transducer | Sham comparator | Epidural pressure waveforms will be measured by using a standard invasive monitor pressure transducer Receives: Device: CompuFlo |
| CompuFlo | Active comparator | Epidural pressure waveforms will be measured by using the CompuFlo Instrument Receives: Device: CompuFlo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave
Occurrence of epidural pulse wave
Measured: up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jul 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- European e-Learning School in Obstetric Anesthesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgio Capogna, MD, Study director, European e-Learning School in Obstetric Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240197
- Sponsor's protocol ID
- EESOA5
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hilber ND, Rijs K, Klimek M, Saenz G, Aloweidi A, Rossaint R, Heesen M. A systematic review of the diagnostic accuracy of epidural wave form analysis to identify the epidural space in surgical and labor patients. Minerva Anestesiol. 2019 Apr;85(4):393-400. doi: 10.23736/S0375-9393.18.13089-6. Epub 2018 Nov 22.
PubMed 30482001
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Pressure Waveform Analysis to Determine Correct Epidural Catheter Placement; a Comparison Between Pressure Transducer and the CompuFlo® CathCheck™ System
- ClinicalTrials.gov ID
- NCT04240197
- Acronym / sponsor ID
- EESOA5
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- European e-Learning School in Obstetric AnesthesiaUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 27 Jan 2020 (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 purpose of this single arm, open label study will be to compare and evaluate the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space when compared to the standard pressure transducer.
Detailed description
40 patients who had an epidural functioning catheter previously positioned for anesthesia or analgesia will be enrolled. After removing the epidural filter and after having zeroed the instrument, the investigator will connect in a random fashion sequence, a standard pressure transducer attached to a standard invasive blood pressure monitor or to the CompuFlo CathCheck instrument to observe and record the occurrence of epidural pulsatile waveform.
The investigator will also note and evaluate:
The volume of saline priming necessary to obtain the waveform The effects of patient's position on the occurrence and amplitude of epidural pulsatile waveform
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Pressure Transducer | Sham comparator | Device: CompuFloEpidural pressure waveforms will be measured by using a standard invasive monitor pressure transducer |
| CompuFlo | Active comparator | Device: CompuFloEpidural pressure waveforms will be measured by using the CompuFlo Instrument |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with an epidural lumbar catheter for anesthesia or analgesia
Key exclusion criteria (1 listed)
- patients with malfunction or dislodgement of the epidural catheter
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 |
|---|---|---|
| CompuFloAlso: Standard Pressure TransducerThe occurrence of epidural pulse waves with CompuFlo and with standard pressure trnsducer | Device | CompuFlo, Standard Pressure Transducer |
Primary outcome
Pulse Wave
Time frame: up to 15 minutes
Occurrence of epidural pulse wave
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 23 Mar 2022.
- Background: PubMed 30482001Hilber ND, Rijs K, Klimek M, Saenz G, Aloweidi A, Rossaint R, Heesen M. A systematic review of the diagnostic accuracy of epidural wave form analysis to identify the epidural space in surgical and labor patients. Minerva Anestesiol. 2019 Apr;85(4):393-400. doi: 10.23736/S0375-9393.18.13089-6. Epub 2018 Nov 22.
- Individual participant dataSharing planned: No
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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.
Giorgio Capogna, MD study director
European e-Learning School in Obstetric Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CompuFlo in people with Anesthesia, run by European e-Learning School in Obstetric Anesthesia at 1 site in Italy.
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 23 Mar 2022. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Pulse Wave (time frame: up to 15 minutes). 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 NCT04240197, which also lists 1 linked publication.
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 23 Mar 2022.