AnesthesiaNCT03376256
Compuflo Instrument for Thoracic ES Identification
A study testing Compuflo Epidural Instrument in people with Anesthesia and Thoracic, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, Thoracic
- What is being tested?
- Compuflo Epidural Instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2018to 17 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years inclusive
- BMI 18.5 to 40 inclusive
- Scheduled for thoracic epidural anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Compuflo Epidural Instrument for Thoracic Epidural Space Identification
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
- Being tested
- Compuflo Epidural Instrument
- Keywords
- thoracic epidural, pressure measurement, device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compuflo Epidural InstrumentDevice
Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Compuflo Epidural Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Levels in Thoracic Epidural Space
The Compuflo Epidural Instrument measures the pressure levels in millimeters of mercury (mmHg) in the thoracic epidural space
Measured: Day 1
Secondary outcomes (1)
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start11 Jul 2018
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Why it stopped: Difficulty in participant recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralf E. Gebhard, MD, University of Miami
- Investigators
- Ralf E Gebhard, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376256
- Sponsor's protocol ID
- 20170665
- Status last verified
- Nov 2020
- First submitted
- 12 Dec 2017
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26469364Tsui 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.
PubMed 9717595Kuo 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.
PubMed 25437497Vallejo 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.
PubMed 20696564Lechner 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.
PubMed 12133089Crawford 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.
PubMed 4265424Thangamuthu 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.
PubMed 23932551Ready 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.
PubMed 10588551
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Compuflo Epidural Instrument for Thoracic Epidural Space Identification
- ClinicalTrials.gov ID
- NCT03376256
- Acronym / sponsor ID
- 20170665
- Conditions
- Anesthesia, Thoracic
- Keywords
- thoracic epidural, pressure measurement, device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in participant recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase A - Thoracic ES with LOR | Experimental | Device: Compuflo Epidural InstrumentPatients 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. |
| Phase B - Thoracic ES with Compuflo | Experimental | Device: Compuflo Epidural InstrumentPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 80 years inclusive
- BMI 18.5 to 40 inclusive
- Scheduled for thoracic epidural anesthesia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compuflo Epidural InstrumentCompuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia. | Device | Phase A - Thoracic ES with LOR, Phase B - Thoracic ES with Compuflo |
Primary outcome
Pressure Levels in Thoracic Epidural Space
Time frame: Day 1
The Compuflo Epidural Instrument measures the pressure levels in millimeters of mercury (mmHg) in the thoracic epidural space
1 secondary outcome
Percent of Successful Performance of Thoracic Epidural Anesthesia Using Loss of Resistance Technique
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26469364Leurcharusmee 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.
- Background: PubMed 9717595Tsui 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.
- Background: PubMed 25437497Kuo 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.
- Background: PubMed 20696564Vallejo 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.
- Background: PubMed 12133089Lechner 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.
- Background: PubMed 4265424Crawford 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.
- Background: PubMed 23932551Thangamuthu 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.
- Background: PubMed 10588551Ready 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf E Gebhard, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compuflo Epidural Instrument in people with Anesthesia and Thoracic, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Levels in Thoracic Epidural Space (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376256, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.