Anesthesia, EpiduralNCT04240912
Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System
An observational study of Anesthesia, Epidural, 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 evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anesthesia, Epidural
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 28 Apr 2020to 30 Sep 2020
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: healthy women in active labor who received epidural analgesia
Who may be able to join
- healthy women in active labor who received epidural analgesia
Who cannot join
- healthy women in active labor who received ineffective epidural analgesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System in Laboring Women.
The purpose of this single arm, open label study will be to evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space.
Read the detailed description
The purpose of this single arm, open label study will be to evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space.
The primary objective will be the correlation between the appearance of EPW recorded by the CompuFlo and the correct placement of the epidural catheter as assessed by the occurrence of adequate bilateral labor analgesia.
Secondary objectives will be the effects of the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter on the EPW.
The study will enroll consecutive parturients in active labor who have received effective epidural labor analgesia with an epidural catheter. After epidural catheter priming, the occurrence or the absence of EPW will be investigated.
Endpoints (quantitative measurements required by the objectives)
Primary end points:
- appearance and recording of EPW by using the CompuFlo instrument.
- absence of EPW in case of inadequate analgesia, intravascular placement or unilateral analgesia 3) successful analgesia, defined as the occurrence of a visual analogue pain score less than 10/100 during the study period
Secondary end points:
- time from the last epidural bolus and the EPW recordings
- EPW recordings between uterine contractions and at the apex of a uterine contraction
- EPW recordings when the patient is supine or in left lateral decubitus
- EPW recordings during 10 sec Valsalva maneuver
- priming volume of saline necessary to detect EPW (5,10,15,20 ml)
Tertiary end points:
- epidural actual pressure (mmHg)
- EPW disappearance or absence during catheter removal or during ineffective analgesia
- Conditions
- Anesthesia, Epidural
- Being tested
- CompuFlo Epidural Computer Controlled System
- Keywords
- Epidural labor analgesia, Epidural catheter assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CompuFlo Epidural Computer Controlled SystemDevice
The CompuFlo Epidural Instrument allows the objective identification of the epidural space by pressure measurement at the needle tip and consequently enables the physician to perform epidural anesthesia and epidural injections using standard methods. However, for the purpose of this study the instrument will be used only as a monitor to detect the occurrence of EPW.
The CompuFlo Epidural Computer Controlled Anesthesia System has received a CE mark in the European Union and it received 510(k) clearance from the FDA in June 2017.
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of epidural pulse waves (EPW)
The occurrence of EPW recorded by the CompuFlo in working epidural catheters (epidural catheter which have produced epidural block)
Measured: up to 5 minutes
Secondary outcomes (3)
patient position
Whether patients' position (sitting or left lateral decubitus) affects the presence/absence of epidural pulse wave and/or its amplitude
Measured: up to 10 minutes
uterine contractions
Whether the presence/absence of epidural pulse wave and/or its amplitude changes during uterine contraction in laboring women
Measured: up to 10 minutes
valsalva
Whether the presence/absence of epidural pulse wave and/or its amplitude changes during the Valsava maneuvre in laboring women
Measured: up to 10 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 start28 Apr 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Prospective
- 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
- NCT04240912
- Sponsor's protocol ID
- EESOA4
- Status last verified
- Feb 2021
- First submitted
- 15 Jan 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Capogna G, Camorcia M, Coccoluto A, Micaglio M, Velardo M. Experimental validation of the CompuFlo(R) epidural controlled system to identify the epidural space and its clinical use in difficult obstetric cases. Int J Obstet Anesth. 2018 Nov;36:28-33. doi: 10.1016/j.ijoa.2018.04.008. Epub 2018 May 4.
PubMed 29914784Vaira P, Camorcia M, Palladino T, Velardo M, Capogna G. Differentiating False Loss of Resistance from True Loss of Resistance While Performing the Epidural Block with the CompuFlo(R) Epidural Instrument. Anesthesiol Res Pract. 2019 Feb 3;2019:5185901. doi: 10.1155/2019/5185901. eCollection 2019.
PubMed 30863447Gebhard RE, Moeller-Bertram T, Dobecki D, Peralta F, Pivalizza EG, Rupasinghe M, Ilic S, Hochman M. Objective Epidural Space Identification Using Continuous Real-Time Pressure Sensing Technology: A Randomized Controlled Comparison With Fluoroscopy and Traditional Loss of Resistance. Anesth Analg. 2019 Nov;129(5):1319-1327. doi: 10.1213/ANE.0000000000003873.
PubMed 31237571Al-Aamri I, Derzi SH, Moore A, Elgueta MF, Moustafa M, Schricker T, Tran DQ. Reliability of pressure waveform analysis to determine correct epidural needle placement in labouring women. Anaesthesia. 2017 Jul;72(7):840-844. doi: 10.1111/anae.13872. Epub 2017 Apr 17.
PubMed 28419420
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System in Laboring Women.
- ClinicalTrials.gov ID
- NCT04240912
- Acronym / sponsor ID
- EESOA4
- Conditions
- Anesthesia, Epidural
- Keywords
- Epidural labor analgesia, Epidural catheter assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- European e-Learning School in Obstetric AnesthesiaUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (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 evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space.
Detailed description
The purpose of this single arm, open label study will be to evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space.
The primary objective will be the correlation between the appearance of EPW recorded by the CompuFlo and the correct placement of the epidural catheter as assessed by the occurrence of adequate bilateral labor analgesia.
Secondary objectives will be the effects of the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter on the EPW.
The study will enroll consecutive parturients in active labor who have received effective epidural labor analgesia with an epidural catheter. After epidural catheter priming, the occurrence or the absence of EPW will be investigated.
Endpoints (quantitative measurements required by the objectives)
Primary end points:
- appearance and recording of EPW by using the CompuFlo instrument.
- absence of EPW in case of inadequate analgesia, intravascular placement or unilateral analgesia 3) successful analgesia, defined as the occurrence of a visual analogue pain score less than 10/100 during the study period
Secondary end points:
- time from the last epidural bolus and the EPW recordings
- EPW recordings between uterine contractions and at the apex of a uterine contraction
- EPW recordings when the patient is supine or in left lateral decubitus
- EPW recordings during 10 sec Valsalva maneuver
- priming volume of saline necessary to detect EPW (5,10,15,20 ml)
Tertiary end points:
- epidural actual pressure (mmHg)
- EPW disappearance or absence during catheter removal or during ineffective analgesia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- healthy women in active labor who received epidural analgesia
Key inclusion criteria (1 listed)
- healthy women in active labor who received epidural analgesia
Key exclusion criteria (1 listed)
- healthy women in active labor who received ineffective epidural analgesia
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 |
|---|---|---|
| CompuFlo Epidural Computer Controlled SystemThe CompuFlo Epidural Instrument allows the objective identification of the epidural space by pressure measurement at the needle tip and consequently enables the physician to perform epidural anesthesia and epidural injections using standard methods. However, for the purpose of this study the instrument will be used only as a monitor to detect the occurrence of EPW. The CompuFlo Epidural Computer Controlled Anesthesia System has received a CE mark in the European Union and it received 510(k) clearance from the FDA in June 2017. | Device | – |
Primary outcome
occurrence of epidural pulse waves (EPW)
Time frame: up to 5 minutes
The occurrence of EPW recorded by the CompuFlo in working epidural catheters (epidural catheter which have produced epidural block)
3 secondary outcomes
patient position
Time frame: up to 10 minutes
uterine contractions
Time frame: up to 10 minutes
valsalva
Time frame: up to 10 minutes
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 3 Feb 2021.
- Background: PubMed 29914784Capogna G, Camorcia M, Coccoluto A, Micaglio M, Velardo M. Experimental validation of the CompuFlo(R) epidural controlled system to identify the epidural space and its clinical use in difficult obstetric cases. Int J Obstet Anesth. 2018 Nov;36:28-33. doi: 10.1016/j.ijoa.2018.04.008. Epub 2018 May 4.
- Background: PubMed 30863447Vaira P, Camorcia M, Palladino T, Velardo M, Capogna G. Differentiating False Loss of Resistance from True Loss of Resistance While Performing the Epidural Block with the CompuFlo(R) Epidural Instrument. Anesthesiol Res Pract. 2019 Feb 3;2019:5185901. doi: 10.1155/2019/5185901. eCollection 2019.
- Background: PubMed 31237571Gebhard RE, Moeller-Bertram T, Dobecki D, Peralta F, Pivalizza EG, Rupasinghe M, Ilic S, Hochman M. Objective Epidural Space Identification Using Continuous Real-Time Pressure Sensing Technology: A Randomized Controlled Comparison With Fluoroscopy and Traditional Loss of Resistance. Anesth Analg. 2019 Nov;129(5):1319-1327. doi: 10.1213/ANE.0000000000003873.
- Background: PubMed 28419420Al-Aamri I, Derzi SH, Moore A, Elgueta MF, Moustafa M, Schricker T, Tran DQ. Reliability of pressure waveform analysis to determine correct epidural needle placement in labouring women. Anaesthesia. 2017 Jul;72(7):840-844. doi: 10.1111/anae.13872. Epub 2017 Apr 17.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Anesthesia, Epidural, 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 3 Feb 2021. 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. 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?
occurrence of epidural pulse waves (EPW) (time frame: up to 5 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 NCT04240912, which also lists 4 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 3 Feb 2021.