Compuflo Instrument for Thoracic ES Identification

NCT03376256 | Terminated Results FDA Device

• 1 other identifier: 20170665
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Thoracic

Keywords

thoracic epidural; pressure measurement; device

Outcome Measures

Primary Outcomes (1)

• Pressure Levels in Thoracic Epidural Space

  The Compuflo Epidural Instrument measures the pressure levels in millimeters of mercury (mmHg) in the thoracic epidural space

  Day 1

Secondary Outcomes (1)

• Percent of Successful Performance of Thoracic Epidural Anesthesia Using Loss of Resistance Technique

  Day 1

Study Arms (2)

Phase A - Thoracic ES with LOR

EXPERIMENTAL

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.

Device: Compuflo Epidural Instrument

Phase B - Thoracic ES with Compuflo

EXPERIMENTAL

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.

Device: Compuflo Epidural Instrument

Interventions

Compuflo Epidural Instrument DEVICE

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

Phase A - Thoracic ES with LOR; Phase B - Thoracic ES with Compuflo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Related Publications (8)

• 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.

  PMID: 26469364 BACKGROUND

• 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.

  PMID: 9717595 BACKGROUND

• 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.

  PMID: 25437497 BACKGROUND

• 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.

  PMID: 20696564 BACKGROUND

• 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.

  PMID: 12133089 BACKGROUND

• 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.

  PMID: 4265424 BACKGROUND

• 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.

  PMID: 23932551 BACKGROUND

• 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.

  PMID: 10588551 BACKGROUND

Limitations and Caveats

To protect participant privacy and maintain confidentiality, results will not be reported.

Results Point of Contact

• Title: Dr. Ralf Gebhard
• Organization: University of Miami

rgebhard@med.miami.edu

3055858365

Study Officials

• Ralf E Gebhard, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Anesthesiology

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: July 11, 2018
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: December 3, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)