Compuflo Instrument for Thoracic ES Identification

Anesthesia Clinical Trial

Official title:

Evaluation of the Compuflo Epidural Instrument for Thoracic Epidural Space Identification

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03376256
• Other study ID #: 20170665
• Status: Terminated
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: July 17, 2018

Study information

• Verified date: November 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Aneurysm, Dissecting
• Thoracic

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (8)

Crawford JS. The second thousand epidural blocks in an obstetric hospital practice. Br J Anaesth. 1972 Dec;44(12):1277-87. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ready LB. Acute pain: lessons learned from 25,000 patients. Reg Anesth Pain Med. 1999 Nov-Dec;24(6):499-505. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent of Successful Performance of Thoracic Epidural Anesthesia Using Loss of Resistance Technique	Percent of thoracic epidural anesthesia procedures using LOR that result in a loss of sensation to cold in at least one dermatome, either unilateral or bilateral	Day 1