Epidural; Anesthesia Clinical Trial
— MC-PMSOfficial title:
Multi-Center Post-Marketing Study Protocol: (MC-PMS) A Single-arm Open Label Observational Study to Further Document the Safety and Effectiveness of the Epidural Space Verification With the CompuFlo® Epidural Computer Controlled System
NCT number | NCT03625232 |
Other study ID # | EESOA |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | October 30, 2019 |
Verified date | December 2019 |
Source | European e-Learning School in Obstetric Anesthesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | October 30, 2019 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Leuven | Leuven | |
Chile | Alemanno Hospital | Santiago | |
Germany | Klinik und Poliklinik für Anästhesiologie | Würzburg | |
Italy | Casa di Cura Gibiino, Università di Catania | Catania | |
Italy | Careggi Hospital | Florence | |
Italy | Casa Sollievo Sofferenza, S Giovanni Rotondo | Foggia | |
Italy | Clinica Mangiagalli | Milan | |
Italy | Ospedale Buccheri La Ferla | Palermo | |
Italy | Città di Roma Hospital | Rome | |
Spain | Madrid University Hospital | Madrid | |
United Kingdom | Frimley Park Hospital | Frimley |
Lead Sponsor | Collaborator |
---|---|
European e-Learning School in Obstetric Anesthesia |
Belgium, Chile, Germany, Italy, Spain, United Kingdom,
Capogna G, Coccoluto A, Capogna E, Del Vecchio A. Objective Evaluation of a New Epidural Simulator by the CompuFlo(®) Epidural Instrument. Anesthesiol Res Pract. 2018 Jun 26;2018:4710263. doi: 10.1155/2018/4710263. eCollection 2018. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Complications | Number of patients having inadvertent dural punture Number of patients having post dural punture headache | 36 hours | |
Secondary | Physician Concordance Index | The agreement between the physician's reported sensation and the variation of pressure given by the CompuFlo® during the needle tracking from its insertion until the identification of the epidural space will be evaluated by using a 5 poin Likert scale 1 2 3 4 5 (From Strongly disagree to Strongly agree) Completed immediately after each procedure by the physician who performed block |
24 hours | |
Secondary | Secondary Epidural Veriification | After documenting the significant drop in pressure (mmHg) for at least 5 seconds, with no further needle movement: additional 5 seconds of pressure data (mmHg) will be recorded to identify the formation of a low and stable low pressure plateau Compuflo motor will be stopped and the pressure will be recorded for 5 additional seconds, while the needle is still in the epidural space to record the EPIDURAL SPACE PRESSURE (mmHg). The patients will be requested either to cough and the epidural pressure will be recorded (PRESSURE AFTER COUGH, mmHg)) or to perform a 2-3 seconds Valsalva maneuver andthe epidural pressure at the apex of the maneuvre (PRESSURE AFTER VALSALVA, mmHg) will be recorded . |
15 minutes |
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