NCT04205773

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

28 days

First QC Date

December 17, 2019

Last Update Submit

December 19, 2019

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

CompuFloDEVICE

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant patients
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Obstetric patients who received an epidural block and have an epidural catheter

You may qualify if:

  • Obstetric patients
  • Must have an epidural catheter

You may not qualify if:

  • Non-obstetric patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

EESOA Maternal Neonatal Simulation Centre

Roma, 00151, Italy

Location

Città di Roma Hospital

Rome, Italy

Location

Related Publications (1)

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

    PMID: 30046305BACKGROUND

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

December 17, 2019

First Posted

December 19, 2019

Study Start

November 1, 2019

Primary Completion

November 29, 2019

Study Completion

November 30, 2019

Last Updated

December 20, 2019

Record last verified: 2019-12

Locations

IT(2)