Epidural Catheter Location by Epidural Pressure Waveform

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2019-11-30

Brief Summary

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

Detailed Description

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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

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Anesthesia, Local

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Obstetric patients
* Must have an epidural catheter

Exclusion Criteria

• Non-obstetric patients

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giorgio Capogna, MD

Role: STUDY_DIRECTOR

European e-Learning School in Obstetric Anesthesia

Locations

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EESOA Maternal Neonatal Simulation Centre

Roma, , Italy

Site Status

Città di Roma Hospital

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND

PMID: 30046305 (View on PubMed)

Other Identifiers

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EESOA3

Identifier Type: -

Identifier Source: org_study_id