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Compuflo Instrument for Thoracic ES Identification

NCT ID: NCT03376256

Last Updated: 2020-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-11

Study Completion Date

2018-07-17

Brief Summary

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The purpose of this pilot study is to evaluate whether the Compuflo Epidural Instrument injection pump technology, which is FDA approved for lumbar epidural anesthesia, is also capable of identifying the thoracic epidural space through measurement of pressure levels. While this device is approved by the FDA for use in the procedure of the lumbar epidural, it is not used to perform the epidural procedure but rather to measure the epidural pressure. This study will likewise measure the epidural pressure.

Detailed Description

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Conditions

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Anesthesia Thoracic

Keywords

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thoracic epidural pressure measurement device

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Phase A - Thoracic ES with LOR

Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until loss of resistance (LOR) is perceived to identify the thoracic epidural space (ES). The Compuflo Epidural Instrument will be used to record pressure readings. The thoracic epidural procedure will then continue per standard of care.

Group Type EXPERIMENTAL

Compuflo Epidural Instrument

Intervention Type DEVICE

Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.

Phase B - Thoracic ES with Compuflo

Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until the Compuflo Epidural Instrument indicates that pressure has decreased. The loss of resistance technique will then be used to identify the thoracic epidural space. The thoracic epidural procedure will then continue per standard of care.

Group Type EXPERIMENTAL

Compuflo Epidural Instrument

Intervention Type DEVICE

Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.

Interventions

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Compuflo Epidural Instrument

Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 80 years inclusive
* BMI 18.5 to 40 inclusive
* Scheduled for thoracic epidural anesthesia

Exclusion Criteria

* Patients younger than 18 years or older than 80 years of age
* Patients with BMI less than 18.5 or greater than 40
* Contraindication to thoracic epidural anesthesia
* Allergy or hypersensitivity to local anesthetics
* Patients with preexisting nerve damage
* Patients unable to provide written informed consent
* Individuals of vulnerable populations: children, pregnant women, prisoners
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Ralf E. Gebhard, MD

Professor of Clinical Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralf E Gebhard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami Hospital

Miami, Florida, United States

Site Status

Countries

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United States

References

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Leurcharusmee P, Arnuntasupakul V, Chora De La Garza D, Vijitpavan A, Ah-Kye S, Saelao A, Tiyaprasertkul W, Finlayson RJ, Tran DQ. Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):694-7. doi: 10.1097/AAP.0000000000000313.

Reference Type BACKGROUND
PMID: 26469364 (View on PubMed)

Tsui BC, Gupta S, Finucane B. Confirmation of epidural catheter placement using nerve stimulation. Can J Anaesth. 1998 Jul;45(7):640-4. doi: 10.1007/BF03012093.

Reference Type BACKGROUND
PMID: 9717595 (View on PubMed)

Kuo WC, Kao MC, Chang KY, Teng WN, Tsou MY, Chang Y, Ting CK. Fiber-needle swept-source optical coherence tomography system for the identification of the epidural space in piglets. Anesthesiology. 2015 Mar;122(3):585-94. doi: 10.1097/ALN.0000000000000531.

Reference Type BACKGROUND
PMID: 25437497 (View on PubMed)

Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.

Reference Type BACKGROUND
PMID: 20696564 (View on PubMed)

Lechner TJ, van Wijk MG, Maas AJ. Clinical results with a new acoustic device to identify the epidural space. Anaesthesia. 2002 Aug;57(8):768-72. doi: 10.1046/j.1365-2044.2002.02621.x.

Reference Type BACKGROUND
PMID: 12133089 (View on PubMed)

Crawford JS. The second thousand epidural blocks in an obstetric hospital practice. Br J Anaesth. 1972 Dec;44(12):1277-87. doi: 10.1093/bja/44.12.1277. No abstract available.

Reference Type BACKGROUND
PMID: 4265424 (View on PubMed)

Thangamuthu A, Russell IF, Purva M. Epidural failure rate using a standardised definition. Int J Obstet Anesth. 2013 Nov;22(4):310-5. doi: 10.1016/j.ijoa.2013.04.013. Epub 2013 Aug 6.

Reference Type BACKGROUND
PMID: 23932551 (View on PubMed)

Ready LB. Acute pain: lessons learned from 25,000 patients. Reg Anesth Pain Med. 1999 Nov-Dec;24(6):499-505. doi: 10.1016/s1098-7339(99)90038-x. No abstract available.

Reference Type BACKGROUND
PMID: 10588551 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20170665

Identifier Type: -

Identifier Source: org_study_id