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NCT04205773 Clinical Trial

Epidural Catheter Location by Epidural Pressure Waveform

Anesthesia, Local Clinical Trial

Official title:
Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the CompuFlo Epidural Instrument

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04205773
Other study ID # EESOA3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date November 30, 2019

Study information
Verified date December 2019
Source European e-Learning School in Obstetric Anesthesia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this preliminary study was to evaluate the new CompuFlo instrument which allows pulsatile waveform recordings.

Description:

30 epidural catheters previously successfully used for obstetric anesthesia or analgesia and about to be removed were tested. All patients were given 5 mL 2% lidocaine to test the catheter before its removal. After priming with 5 mL saline, the catheter was connected to CompuFlo to record the occurrence of pulsatile waveforms and/or their disappearance during its removal. The epidural catheter was marked at the skin level to record the distance between the skin at the time of measurements. The power analysis required a sample of 30 observations to set 80% test power and 95% significance level.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date November 30, 2019
Est. primary completion date November 29, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Obstetric patients

- Must have an epidural catheter

Exclusion criteria

• Non-obstetric patients

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CompuFlo
After priming with 5 mL saline, the catheter was connected to CompuFlo to record the occurrence of pulsatile waveforms and/or their disappearance during its removal

Locations
Country Name City State
Italy EESOA Maternal Neonatal Simulation Centre Roma
Italy Città di Roma Hospital Rome

Sponsors (1)
Lead Sponsor Collaborator
European e-Learning School in Obstetric Anesthesia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Capogna G, Coccoluto A, Capogna E, Del Vecchio A. Objective Evaluation of a New Epidural Simulator by the CompuFlo(®) Epidural Instrument. Anesthesiol Res Pract. 2018 Jun 26;2018:4710263. doi: 10.1155/2018/4710263. eCollection 2018. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary pulsatile waveforms observation (presence or absence) The epidural catheter was considered to be in the epidural space if the appearance of pulsatile waveforms were observed, and confirmed by the occurrence of L2-3 sensory block after the test dose. The disappearance of the pulsatile waveforms when the catheter was extracted from the epidural space was also noted. 30 minutes
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