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Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240912
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
European e-Learning School in Obstetric Anesthesia

Brief 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 (EPW) to assess the correct placement of the catheter in the epidural space.

Condition or disease Intervention/treatment
Anesthesia, Epidural Device: CompuFlo Epidural Computer Controlled System

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:

  1. appearance and recording of EPW by using the CompuFlo instrument.
  2. 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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System in Laboring Women.
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Intervention Details:
  • Device: CompuFlo Epidural Computer Controlled System

    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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. patient position [ Time Frame: up to 10 minutes ]
    Whether patients' position (sitting or left lateral decubitus) affects the presence/absence of epidural pulse wave and/or its amplitude

  2. uterine contractions [ Time Frame: up to 10 minutes ]
    Whether the presence/absence of epidural pulse wave and/or its amplitude changes during uterine contraction in laboring women

  3. valsalva [ Time Frame: up to 10 minutes ]
    Whether the presence/absence of epidural pulse wave and/or its amplitude changes during the Valsava maneuvre in laboring women



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   laboring women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
healthy women in active labor who received epidural analgesia
Criteria

Inclusion Criteria:

  • healthy women in active labor who received epidural analgesia

Exclusion Criteria:

  • healthy women in active labor who received ineffective epidural analgesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240912


Contacts
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Contact: Giorgio Capogna, MD +39 06 58237365 capogna.eesoa@gmai.com

Locations
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Italy
Città di Roma Hospital Recruiting
Rome, Italy
Contact: Michela Camorcia, MD         
Sponsors and Collaborators
European e-Learning School in Obstetric Anesthesia
Investigators
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Study Director: Giorgio Capogna, MD European e-Learning School in Obstetric Anesthesia
Publications:
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Responsible Party: European e-Learning School in Obstetric Anesthesia
ClinicalTrials.gov Identifier: NCT04240912    
Other Study ID Numbers: EESOA4
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by European e-Learning School in Obstetric Anesthesia:
Epidural labor analgesia
Epidural catheter assessment