CompuFlo Thoracic Epidural Study

NCT03826186 | Completed Results DMC FDA Device

• 1 other identifier: 201812716
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Traditionally, loss-of-resistance (LOR) to air or saline with a special ground-glass syringe is the technique used to identify epidural space, but failure rates up to 30% have been reported using this technique for thoracic epidural placement. This failure rate has sparked the search for newer techniques to improve the success rate for placement.The CompuFlo epidural system is a device that provides anesthesiologists and other healthcare providers the ability to quantitatively determine and document the pressure at the needle tip in real time. The device's proprietary dynamic pressure sensing technology (DPS) allows it to provide objective visual and audible in-tissue pressure feedback that allows anesthesiologists to identify the epidural space. The purpose this research study is to compare the success rate of the two different approaches (traditional method v/s CompuFlo assisted) to thoracic epidural placement.

Conditions

Thoracic Epidural Anesthesia

Keywords

CompuFlo; dynamic pressure sensing

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Thoracic Epidural Catheter Placement

  Successful placement of thoracic epidural analgesia will be determined by the loss of cold sensation on the chest or abdomen depending on the site of epidural placement using a dermatome bilaterally. Subjects will be tested at 10 minute intervals.

  Maximum 20 minutes post administration of epidural test dose

Secondary Outcomes (7)

• Amount of Time Required to Complete the Procedure

  During procedure, assessed up to 15 minutes

• Number of Participants Who Reported Loss of Cold Sensation at Various Time Points

  Up to 20 minutes post administration of epidural test dose

• Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure

  Up to 20 minutes post administration of epidural test dose

• Number of Participants With Significant Change in Systolic Blood Pressure

  Up to 20 minutes post administration of epidural test dose

• Number of Participants Whose Provider Answered "Yes" or "No" to Ease of Catheter Placement

  During procedure, assessed up to 15 minutes

Study Arms (2)

Traditional epidural group

ACTIVE COMPARATOR

The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.

Device: Traditional (loss-of-resistance technique) thoracic epidural placement

CompuFlo epidural group

EXPERIMENTAL

This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.

Device: CompuFlo thoracic epidural placement

Interventions

Traditional (loss-of-resistance technique) thoracic epidural placement DEVICE

Thoracic epidurals will be administered using the traditional loss-of resistance technique.

Traditional epidural group

CompuFlo thoracic epidural placement DEVICE

Pressure sensing technology to consistently and accurately identify the thoracic epidural space.

CompuFlo epidural group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 70
• BMI: 18 to 50 kg/m2
• Require pain control for major thoracic or abdominal surgeries
• Require pain control for rib fractures
• English is the subject's first language
• Must be able to signed informed consent

You may not qualify if:

• Age: Less than 18 and older than 70
• Must be free of significant valvular heart disease
• Pregnant women
• Prisoners
• Contraindication to thoracic epidural anesthesia
• Allergy or hypersensitivity to local anesthetics
• Unable to provide written informed consent

Sponsors & Collaborators

• YATISH SIDDAPURA RANGANATH: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (7)

• Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.

  PMID: 14612482 RESULT

• Carli F, Mayo N, Klubien K, Schricker T, Trudel J, Belliveau P. Epidural analgesia enhances functional exercise capacity and health-related quality of life after colonic surgery: results of a randomized trial. Anesthesiology. 2002 Sep;97(3):540-9. doi: 10.1097/00000542-200209000-00005.

  PMID: 12218518 RESULT

• Popping DM, Elia N, Marret E, Remy C, Tramer MR. Protective effects of epidural analgesia on pulmonary complications after abdominal and thoracic surgery: a meta-analysis. Arch Surg. 2008 Oct;143(10):990-9; discussion 1000. doi: 10.1001/archsurg.143.10.990.

  PMID: 18936379 RESULT

• 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 RESULT

• Parra MC, Washburn K, Brown JR, Beach ML, Yeager MP, Barr P, Bonham K, Lamb K, Loftus RW. Fluoroscopic Guidance Increases the Incidence of Thoracic Epidural Catheter Placement Within the Epidural Space: A Randomized Trial. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):17-24. doi: 10.1097/AAP.0000000000000519.

  PMID: 27922948 RESULT

• Gong Y, Shi H, Wu J, Labu D, Sun J, Zhong H, Li L, Xin X, Wang L, Wu L, Ma D. Pressure waveform-guided epidural catheter placement in comparison to the loss-of-resistance conventional method. J Clin Anesth. 2014 Aug;26(5):395-401. doi: 10.1016/j.jclinane.2014.01.015. Epub 2014 Aug 27.

  PMID: 25172504 RESULT

• Ranganath YS, Ramanujam V, Al-Hassan Q, Sibenaller Z, Seering MS, Singh TSS, Punia S, Parra MC, Wong CA, Sondekoppam RV. Loss-of-Resistance Versus Dynamic Pressure-Sensing Technology for Successful Placement of Thoracic Epidural Catheters: A Randomized Clinical Trial. Anesth Analg. 2024 Jul 1;139(1):201-210. doi: 10.1213/ANE.0000000000006792. Epub 2024 Jun 17.

  PMID: 38190338 DERIVED

Results Point of Contact

• Title: Vice Chair for Research
• Organization: University of Iowa Hospitals and Clinics

donna-hammond@uiowa.edu

319-335-9595

Study Officials

• Yatish S Ranganath, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Thoracic epidurals are administered. After randomization, one group will receive thoracic epidurals in the traditional way (control group) and the other with CompuFlo assistance (study group).

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 1, 2019
• Study Start: March 26, 2019
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 19, 2022
• Results First Posted: October 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.
• Access Criteria: Individual participant data will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.

Locations

US (1)