Clinical trial NCT04240912: Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System
Official title: Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System in Laboring Women.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Epidural
Keywords: Epidural labor analgesia
Epidural catheter assessment
Lead sponsor: European e-Learning School in Obstetric Anesthesia
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy women in active labor who received epidural analgesia

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.

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

Eligibility criteria: Inclusion Criteria:

* healthy women in active labor who received epidural analgesia

Exclusion Criteria:

* healthy women in active labor who received ineffective epidural analgesia

Primary outcomes:
measure: occurrence of epidural pulse waves (EPW)
timeFrame: up to 5 minutes
Secondary outcomes:
measure: patient position
timeFrame: up to 10 minutes
measure: uterine contractions
timeFrame: up to 10 minutes
measure: valsalva
timeFrame: up to 10 minutes
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Città di Roma Hospital
Study officials:
affiliation: European e-Learning School in Obstetric Anesthesia
name: Giorgio Capogna, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Vaira 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.
citation: Gebhard 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.
citation: Al-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.