NCT04205773

Epidural Catheter Location by Epidural Pressure Waveform

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: European e-Learning School in Obstetric Anesthesia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-01
• Primary completion: 2019-11-29
• Completion: 2019-11-30
• First posted: 2019-12-19
• Last updated: 2019-12-20

Locations

2 sites across 1 country: Italy