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Epidural Catheter Location by Epidural Pressure Waveform

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04205773
Enrollment
30
Registered
2019-12-19
Start date
2019-11-01
Completion date
2019-11-30
Last updated
2019-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

Brief summary

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

Detailed 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.

Interventions

DEVICECompuFlo

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

Sponsors

European e-Learning School in Obstetric Anesthesia
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Obstetric patients * Must have an epidural catheter

Exclusion criteria

• Non-obstetric patients

Design outcomes

Primary

MeasureTime frameDescription
pulsatile waveforms observation (presence or absence)30 minutesThe 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026