EpiduralNCT03165708
Epidural Computer Controlled System for the Epidural Space Verification
An observational study of Epidural, run by Città di Roma Hospital.
Trial summary
The purpose of this study will be to evaluate the inter-rater agreement, or concordance, between an expert anaesthesiologist and the CompuFlo® Epidural Computer Controlled System for the epidural space verification. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Epidural
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2017to 20 May 2017
- 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 parturients
Who may be able to join
- Parturients undergoing epidural block for cesarean section or labor analgesia
Who cannot join
- -
About this study
Official title: Identification of the Epidural Space: a Double Blind Comparison Between th CompuFlo® Epidural Computer Controlled System and the Standard LOR to Saline Technique in Obstetrics
The purpose of this study will be to evaluate the inter-rater agreement, or concordance, between an expert anaesthesiologist and the CompuFlo® Epidural Computer Controlled System for the epidural space verification.
Primary study endpoint will be successful concordance of identification of ligamentum flavum and epidural space during a standard epidural procedure in pregnant patient. Secondary outcome will be successful concordance of identification of bony contact during a standard epidural procedure in pregnant patient.
Read the detailed description
After skin local anesthesia and after the subcutaneous insertion of the epidural Tuohy needle, an independent investigator will make the O point of the CompuFlo® device that will be connected, via a three way stopcock, to the Tuohy needle in order to register, in a double blind way, the delta of pressures encountered by the needle during its advancement.
When the operator will reach the supraspinous ligament, a slight resistance will be encountered due to the nature of the bevel, and the density of the ligament. As soon as this resistance will be felt, the operator immediately will tell the investigator who will flag the CompuFlo® device. If no sensation will be felt the operator will tell "none" to the investigator.
The needle will be then advanced through the loose interspinous ligament which typically offers much less resistance than the sopraspinous ligament (often felt as a "no resistance feeling" in the obstetric patient). Once again, as soon as this loss or reduced or no resistance sensation is felt, the operator immediately will tell the investigator who will flag the CompuFlo® device. If no sensation will be felt the operator will tell "none" to the investigator.
According to the standard epidural technique, the point of the needle will be further advanced. The feeling of a greater increase of resistance, often associated with a "crunch", usually indicates the initial penetration of the needle in the rear wall of the ligamentum flavum. As soon as this resistance or "crunch" is felt, the operator immediately will tell the investigator who will flag the CompuFlo® device.
Then, the operator will remove the stylet and gently will attach to the needle a disposable 10 mL loss of resistance syringe containing a few millimeters (5-7 mL) of sterile saline solution and will open the three way stopcock in order to record both the pressures given-and-received by the CompuFlo® and the pressure produced by the operator's hand.
Constant, unremitting pressure will be now exerted on the plunger of the syringe by the thumb of the dominant hand of the operator in order to obtain the needle advancement solely by means of the pressure exerted by the operator on the plunger of the syringe.
As the point of the needle will emerge from the ligamentum flavum into the epidural space, the resistance suddenly will disappear and the advancement of the needle immediately will stop, (since the driving force exerted on the piston is discharged by the sudden entering of the liquid in the epidural space). As soon as this loss of resistance is felt, the operator immediately will tell the investigator who will who will flag the CompuFlo® device. The operator will stop the procedure for at least 10 seconds to allow the investigator to record the static epidural pressures.
- Conditions
- Epidural
- Keywords
- Epidural technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| anesthesiologist | The active comparators for this study will be expert anaesthesiologists (operator). The operators will be blinded to all visual and audible CompuFlo® real-time pressure feedbacks.Inter-rater agreement, or concordance, between an expert anaesthesiologist and the CompuFlo® Epidural Computer Controlled System for the epidural space verification will be assessed by blinded tagging of the operator's feeling of the ligamenta and epidural space on the screen of the Compuflo to be eventually compared with the pressure's variations |
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance between anesthesiologist and Compuflo
Primary study endpoint will be successful concordance of identification of ligamentum flavum and epidural space during a standard epidural procedure in pregnant patient.
Measured: during epidural technique performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start2 Jan 2017
- Primary completion16 May 2017
- Study completion20 May 2017
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 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Città di Roma Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Capogna, Città di Roma Hospital
- Investigators
- Giorgio Capogna, Principal investigator, Citta di Roma Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165708
- Sponsor's protocol ID
- 001
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghelber 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 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Epidural Space: a Double Blind Comparison Between th CompuFlo® Epidural Computer Controlled System and the Standard LOR to Saline Technique in Obstetrics
- ClinicalTrials.gov ID
- NCT03165708
- Acronym / sponsor ID
- 001
- Conditions
- Epidural
- Keywords
- Epidural technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Città di Roma HospitalUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 20 May 2017 (actual)
- First posted
- 24 May 2017 (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 study will be to evaluate the inter-rater agreement, or concordance, between an expert anaesthesiologist and the CompuFlo® Epidural Computer Controlled System for the epidural space verification.
Primary study endpoint will be successful concordance of identification of ligamentum flavum and epidural space during a standard epidural procedure in pregnant patient. Secondary outcome will be successful concordance of identification of bony contact during a standard epidural procedure in pregnant patient.
Detailed description
After skin local anesthesia and after the subcutaneous insertion of the epidural Tuohy needle, an independent investigator will make the O point of the CompuFlo® device that will be connected, via a three way stopcock, to the Tuohy needle in order to register, in a double blind way, the delta of pressures encountered by the needle during its advancement.
When the operator will reach the supraspinous ligament, a slight resistance will be encountered due to the nature of the bevel, and the density of the ligament. As soon as this resistance will be felt, the operator immediately will tell the investigator who will flag the CompuFlo® device. If no sensation will be felt the operator will tell "none" to the investigator.
The needle will be then advanced through the loose interspinous ligament which typically offers much less resistance than the sopraspinous ligament (often felt as a "no resistance feeling" in the obstetric patient). Once again, as soon as this loss or reduced or no resistance sensation is felt, the operator immediately will tell the investigator who will flag the CompuFlo® device. If no sensation will be felt the operator will tell "none" to the investigator.
According to the standard epidural technique, the point of the needle will be further advanced. The feeling of a greater increase of resistance, often associated with a "crunch", usually indicates the initial penetration of the needle in the rear wall of the ligamentum flavum. As soon as this resistance or "crunch" is felt, the operator immediately will tell the investigator who will flag the CompuFlo® device.
Then, the operator will remove the stylet and gently will attach to the needle a disposable 10 mL loss of resistance syringe containing a few millimeters (5-7 mL) of sterile saline solution and will open the three way stopcock in order to record both the pressures given-and-received by the CompuFlo® and the pressure produced by the operator's hand.
Constant, unremitting pressure will be now exerted on the plunger of the syringe by the thumb of the dominant hand of the operator in order to obtain the needle advancement solely by means of the pressure exerted by the operator on the plunger of the syringe.
As the point of the needle will emerge from the ligamentum flavum into the epidural space, the resistance suddenly will disappear and the advancement of the needle immediately will stop, (since the driving force exerted on the piston is discharged by the sudden entering of the liquid in the epidural space). As soon as this loss of resistance is felt, the operator immediately will tell the investigator who will who will flag the CompuFlo® device. The operator will stop the procedure for at least 10 seconds to allow the investigator to record the static epidural pressures.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anesthesiologist | – | –The active comparators for this study will be expert anaesthesiologists (operator). The operators will be blinded to all visual and audible CompuFlo® real-time pressure feedbacks.Inter-rater agreement, or concordance, between an expert anaesthesiologist and the CompuFlo® Epidural Computer Controlled System for the epidural space verification will be assessed by blinded tagging of the operator's feeling of the ligamenta and epidural space on the screen of the Compuflo to be eventually compared with the pressure's variations |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy parturients
Key inclusion criteria (1 listed)
- Parturients undergoing epidural block for cesarean section or labor analgesia
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
concordance between anesthesiologist and Compuflo
Time frame: during epidural technique performance
Primary study endpoint will be successful concordance of identification of ligamentum flavum and epidural space during a standard epidural procedure in pregnant patient.
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 24 May 2017.
- Results publication: 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.
- 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 principal investigator
Citta di Roma Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Epidural, run by Città di Roma Hospital.
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 24 May 2017. 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?
concordance between anesthesiologist and Compuflo (time frame: during epidural technique performance). 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 NCT03165708, 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 24 May 2017.