Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System
Condition: Anesthesia, Epidural
Study type: Observational

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.
    

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
    

Intervention name(s): CompuFlo Epidural Computer Controlled System
Intervention type(s): Device
Intervention description(s): 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.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy women in active labor who received epidural analgesia
      
Keywords: Epidural labor analgesia; Epidural catheter assessment