Epidural Space Verification With the CompuFlo®

NCT03625232 | Completed FDA Device

• 1 other identifier: EESOA
• Study Type: observational
• Target: 250
• Locations: 6 countries
• Sites: 11

Brief Summary

The purpose of this single arm open-label study is to capture additional data that can add to the original COMPASS (CompuFlo® Assessment Study) clinical trial database that supported the 510(k) application, which was given clearance by the FDA on June 9, 2017.

Conditions

Epidural; Anesthesia

Outcome Measures

Primary Outcomes (3)

• Effectiveness: Visual Analogue Pain Scale

  Number of patients with Visual Analogue Pain Scale (VAPS ) score (0 = non pain; 100 = maximum pain) less than 20 after 20/30 minutes from the epidural analgesic loading dose or for those patients for whom fluoroscopy is performed: Number of patients having correct spread of dye in the epidural space as observed by fluoroscopy

  20 minutes

• Epidural identification

  To Identify and differentiate True-LOR vs. False-LOR and/or Inconclusive-LOR during ES identification by using the Compuflo Epidural Instrument recordings of pressure (delta, mmHg) A True-LOR defined as: An increase in pressure followed by a sudden and sustained (\> 5 seconds) drop in pressure (mmHg) resulting in the formation of a low and stable pressure plateau A False-LOR defined as: An increase of pressure (mmHg) followed by a drop in pressure that is either not sustained or inconclusive of representing a "low and stable pressure plateau" If the pressure (mmHg) rapidly increases after a drop of pressure this is identified as a False-Loss of Resistance and the operator may elect to continue to advance the needle.

  15 minutes

• Complications

  Number of patients having inadvertent dural punture Number of patients having post dural punture headache

  36 hours

Secondary Outcomes (2)

• Physician Concordance Index

  24 hours

• Secondary Epidural Veriification

  15 minutes

Interventions

CompuFlo® Epidural Computer Controlled System DEVICE

The CompuFlo® Epidural Instrument allows the objective identification of the epidural space by pressure measurement at the needle tip and consequently enables the HCP to perform epidural anesthesia and epidural injections using standard methods. Currently, HCPs rely on their subjective perception to feel a "loss of resistance" when inserting an epidural needle to identify the epidural space. The CompuFlo® Epidural Computer Controlled Anesthesia System has received a CE mark in the European Union and it received 510(k) clearance from the FDA in June 2017.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subject population for this study will consist of up to 800 adult subjects between the ages of 18 and 90 (had 18th birthday and had not had their 91st birthday - except for State of Alabama where legal consent for adults is age of 19), of any ethnic background, for whom an epidural procedure is indicated according to their HCP. The subject will meet all the inclusion criteria, have none of the exclusion criteria, give their written Informed Consent to participate in this clinical study after undergoing informed consent process, In the event that a subject's ability to comprehend and communicate is compromised (per the discretion of the Principal Investigator), a legal representative may discuss the study, agree on participation and sign the ICF, on behalf of the subject.

You may qualify if:

• The subject is at least 18 years of age at screening, but has not had his/her 91st birthday.
• The subject is required to have epidural procedure implemented as part of their standard medical treatment according to Principal Investigator assessment.
• The subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment into this study.
• The subject is willing to participate in this study for at least 30 days after the epidural procedure implementation.
• The subject is willing to participate in this study for at least 3 days after the procedure.

You may not qualify if:

• Contraindications for epidural procedure / anesthesia (circumstances where the risks associated with epidural procedures are higher than usual. These circumstances are, but not limited to, anatomical abnormalities, such as spina bifida or scoliosis, infection at or near the site of insertion, allergy to the anesthetic or intended drug, uncorrected hypovolemia, increased intracranial pressure etc.).
• Patients presenting for emergency C-section or other emergencies.
• Exclusive use of other treatments such as intravenous analgesia with opioids.
• Prior back surgery in lumbar area that would prevent epidural access.
• Preexisting neurological deficit that would interfere with dermatome identification.
• The subject observed seizure within 7 days prior to study enrollment.
• Presumed and/or confirmed septic embolus.
• The subject has a skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) in their lumbar region greater than 4 cm2.
• The subject previously participated in another investigational drug or device trial within the preceding 4 weeks.
• Severe co-existing or terminal systemic disease that limits life expectancy or may interfere with study procedures.
• The subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study

Sponsors & Collaborators

• European e-Learning School in Obstetric Anesthesia: lead

Study Sites (11)

University Hospital Leuven

Leuven, Belgium

Location

Alemanno Hospital

Santiago, Chile

Location

Klinik und Poliklinik für Anästhesiologie

Würzburg, Germany

Location

Casa di Cura Gibiino, Università di Catania

Catania, Italy

Location

Careggi Hospital

Florence, Italy

Location

Casa Sollievo Sofferenza, S Giovanni Rotondo

Foggia, Italy

Location

Clinica Mangiagalli

Milan, Italy

Location

Ospedale Buccheri La Ferla

Palermo, Italy

Location

Città di Roma Hospital

Rome, Italy

Location

Madrid University Hospital

Madrid, Spain

Location

Frimley Park Hospital

Frimley, United Kingdom

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: 30046305 BACKGROUND

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: PRINCIPAL INVESTIGATOR
• PI Title: Director EESOA

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 10, 2018
• Study Start: March 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

BE (1); DE (1); ES (1); CL (1); GB (1); IT (6)