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

NCT04240912 | Completed FDA Device

• 1 other identifier: EESOA4
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Epidural

Keywords

Epidural labor analgesia; Epidural catheter assessment

Outcome Measures

Primary Outcomes (1)

• occurrence of epidural pulse waves (EPW)

  The occurrence of EPW recorded by the CompuFlo in working epidural catheters (epidural catheter which have produced epidural block)

  up to 5 minutes

Secondary Outcomes (3)

• patient position

  up to 10 minutes

• uterine contractions

  up to 10 minutes

• valsalva

  up to 10 minutes

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: laboring women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

healthy women in active labor who received epidural analgesia

You may qualify if:

• healthy women in active labor who received epidural analgesia

You may not qualify if:

• healthy women in active labor who received ineffective epidural analgesia

Sponsors & Collaborators

• European e-Learning School in Obstetric Anesthesia: lead

Study Sites (1)

Città di Roma Hospital

Rome, Italy

Location

Related Publications (4)

• 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.

  PMID: 29914784 BACKGROUND

• 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.

  PMID: 30863447 BACKGROUND

• 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.

  PMID: 31237571 BACKGROUND

• 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.

  PMID: 28419420 BACKGROUND

Study Officials

• Giorgio Capogna, MD

  European e-Learning School in Obstetric Anesthesia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 27, 2020
• Study Start: April 28, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

IT (1)