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Completed

NCT Number: NCT04240912

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

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.

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Key information

Conditions

Anesthesia, Epidural

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Città di Roma Hospital

Rome, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy women in active labor who received epidural analgesia

Exclusion criteria

  • healthy women in active labor who received ineffective epidural analgesia

Treatment and study plan

CompuFlo Epidural Computer Controlled System

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

European e-Learning School in Obstetric Anesthesia

Other

Registry information

Official study title

Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System in Laboring Women.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2020
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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