Thoracic Epidural AnesthesiaNCT03826186
CompuFlo Thoracic Epidural Study
A study testing Traditional (loss-of-resistance technique) thoracic epidural placement and CompuFlo thoracic epidural placement in people with Thoracic Epidural Anesthesia, run by YATISH SIDDAPURA RANGANATH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thoracic Epidural Anesthesia
- What is being tested?
- Traditional (loss-of-resistance technique) thoracic epidural placement and CompuFlo thoracic epidural placement
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2019to 1 Jun 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Traditional Loss-of-resistance Technique vs Compuflo-aided Technology for Placement of a Thoracic Epidural Catheter: a Randomized Trial of the Effect on the Success Rate
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.
Read the detailed description
Traditional technique vs CompuFlo use: Using the traditional technique (loss-of-resistance technique), the epidural needle is advanced through the subcutaneous tissues with the needle stylet in place until the needle tip is positioned in the interspinous ligament-this is noted by the proceduralist by an increase in tissue resistance (attempted injection into ligamentous tissue is met with high resistance). The stylet or introducer is removed, and a ground-glass syringe filled with 2-3 mL of saline with an air bubble is attached to the hub of the epidural needle. If the tip of the needle is within the ligament, gentle attempts at injection are met with resistance, and injection of the saline is not possible. The needle is then slowly advanced, millimeter by millimeter, with either continuous or rapidly repeating attempts at injection. As the tip of the needle enters the posterior epidural space, a sudden loss of resistance is noted, and the saline injects easily. Once the needle tip is in the epidural space, the epidural catheter is threaded through the needle and the needle is removed, leaving the catheter sited in the epidural space.
The CompuFlo technique complements this basic technique. Similar to the traditional technique, the needle is advanced through the subcutaneous tissues with the stylet in place until the interspinous ligament is entered, as noted by an increase in tissue resistance. After removing the stylet, flexible tubing from the CompuFlo disposable tubing-syringe set is attached to the hub of the needle instead of the traditional ground-glass syringe. The fluid-filled syringe is placed in the CompuFlo device. The needle is then advanced continuously with the device electronically sensing pressure in real time, providing a numerical value (100 to 150 mm Hg) on the read-out screen. As the tip of the needle enters the posterior epidural space, a sudden loss of resistance (associated with a significant loss of pressure to less than 50 mm Hg or 50% of the starting pressure) is noted. The pressure drop needs to be sustained for at least 5 seconds. An audio signal also signals the acute change in pressure.
- Conditions
- Thoracic Epidural Anesthesia
- Being tested
- Traditional (loss-of-resistance technique) thoracic epidural placement, CompuFlo thoracic epidural placement
- Keywords
- CompuFlo; dynamic pressure sensing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional (loss-of-resistance technique) thoracic epidural placementDevice
Thoracic epidurals will be administered using the traditional loss-of resistance technique.
CompuFlo thoracic epidural placementDevice
Pressure sensing technology to consistently and accurately identify the thoracic epidural space.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: CompuFlo thoracic epidural placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Maximum 20 minutes post administration of epidural test dose
Secondary outcomes (7)
Amount of Time Required to Complete the Procedure
Tuohy needle skin puncture to removal of tuohy (for the last time) from the patient
Measured: During procedure, assessed up to 15 minutes
Number of Participants Who Reported Loss of Cold Sensation at Various Time Points
Record the time it takes for 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.
Measured: Up to 20 minutes post administration of epidural test dose
Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure
Blood pressure was measured at baseline (patient check-in) and then every 5 minutes after administration of test dose in both groups. To observe the trend in blood pressure changes, the mean arterial pressure was used. Results are reported as mean arterial pressure (MAP) since MAP is the average arterial pressure throughout one cardiac cycle, systole and diastole. The MAP was calculated based on the available MAP formula (MAP=diastolic blood pressure (DBP) + 1/3 [systolic blood pressure (SBP) - DBP]).
Measured: Up to 20 minutes post administration of epidural test dose
Number of Participants With Significant Change in Systolic Blood Pressure
A fall in systolic blood pressure by 20% or more from the baseline up to 20 minutes after the initial test dose was considered a significant change.
Measured: Up to 20 minutes post administration of epidural test dose
Number of Participants Whose Provider Answered "Yes" or "No" to Ease of Catheter Placement
The provider was asked to evaluate the ease of catheter threading through the needle after the loss of resistance. This is a "yes" or "no" evaluation asked and answered at the end of the procedure. The question asked was "Was the catheter placement (threading) smooth after loss of resistance?"
Measured: During procedure, assessed up to 15 minutes
Number of Participants With a Positive Meniscus Test
The test involves 3 steps after removal of the filter: (i) the open end of the epidural catheter is lifted and the liquid meniscus present in the catheter is observed to drop rapidly; (ii) the open end of the epidural catheter is lowered and the liquid meniscus is again observed to fill the catheter with clear liquid and no blood; (iii) the presence of air in the catheter during backflow confirms the correct position in the epidural space relative to a position in the subarachnoid space. If the above changes are observed - that would help in secondary confirmation of the epidural space and we would call that a positive test. If the above changes are not observed, it was called as a negative test.
Measured: During procedure, assessed up to 15 minutes
Number of Participants With Unintentional Dural Puncture
The number of unintentional dural punctures during the traditional loss-of-resistance methods will be compared to the unintentional dural punctures while using the CompuFlo assisted technology.
Measured: During procedure, assessed up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start26 Mar 2019
- Primary completion1 Jan 2022
- Study completion1 Jun 2022
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 (7)Papers the sponsor has linked to this study.
- Other trials for Thoracic Epidural 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- YATISH SIDDAPURA RANGANATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YATISH SIDDAPURA RANGANATH, University of Iowa
- Investigators
- Yatish S Ranganath, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826186
- Sponsor's protocol ID
- 201812716
- Status last verified
- Aug 2022
- First submitted
- 22 Jan 2019
- Last updated
- 19 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data (IPD) collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.
Publications
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.
PubMed 14612482Carli 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.
PubMed 12218518Popping 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.
PubMed 18936379Leurcharusmee 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 26469364Parra 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.
PubMed 27922948Gong 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.
PubMed 25172504Ranganath 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.
PubMed 38190338
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Loss-of-resistance Technique vs Compuflo-aided Technology for Placement of a Thoracic Epidural Catheter: a Randomized Trial of the Effect on the Success Rate
- ClinicalTrials.gov ID
- NCT03826186
- Acronym / sponsor ID
- 201812716
- Conditions
- Thoracic Epidural Anesthesia
- Keywords
- CompuFlo; dynamic pressure sensing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- YATISH SIDDAPURA RANGANATHUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Posted 19 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Traditional technique vs CompuFlo use: Using the traditional technique (loss-of-resistance technique), the epidural needle is advanced through the subcutaneous tissues with the needle stylet in place until the needle tip is positioned in the interspinous ligament-this is noted by the proceduralist by an increase in tissue resistance (attempted injection into ligamentous tissue is met with high resistance). The stylet or introducer is removed, and a ground-glass syringe filled with 2-3 mL of saline with an air bubble is attached to the hub of the epidural needle. If the tip of the needle is within the ligament, gentle attempts at injection are met with resistance, and injection of the saline is not possible. The needle is then slowly advanced, millimeter by millimeter, with either continuous or rapidly repeating attempts at injection. As the tip of the needle enters the posterior epidural space, a sudden loss of resistance is noted, and the saline injects easily. Once the needle tip is in the epidural space, the epidural catheter is threaded through the needle and the needle is removed, leaving the catheter sited in the epidural space.
The CompuFlo technique complements this basic technique. Similar to the traditional technique, the needle is advanced through the subcutaneous tissues with the stylet in place until the interspinous ligament is entered, as noted by an increase in tissue resistance. After removing the stylet, flexible tubing from the CompuFlo disposable tubing-syringe set is attached to the hub of the needle instead of the traditional ground-glass syringe. The fluid-filled syringe is placed in the CompuFlo device. The needle is then advanced continuously with the device electronically sensing pressure in real time, providing a numerical value (100 to 150 mm Hg) on the read-out screen. As the tip of the needle enters the posterior epidural space, a sudden loss of resistance (associated with a significant loss of pressure to less than 50 mm Hg or 50% of the starting pressure) is noted. The pressure drop needs to be sustained for at least 5 seconds. An audio signal also signals the acute change in pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Traditional epidural group | Active comparator | Device: Traditional (loss-of-resistance technique) thoracic epidural placementThe traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group. |
| CompuFlo epidural group | Experimental | Device: CompuFlo thoracic epidural placementThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Age: Less than 18 and older than 70
- Must be free of significant valvular heart disease
- Pregnant women
- Prisoners
- Contraindication to thoracic epidural anesthesia
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 |
|---|---|---|
| Traditional (loss-of-resistance technique) thoracic epidural placementThoracic epidurals will be administered using the traditional loss-of resistance technique. | Device | Traditional epidural group |
| CompuFlo thoracic epidural placementPressure sensing technology to consistently and accurately identify the thoracic epidural space. | Device | CompuFlo epidural group |
Primary outcome
Number of Participants With Successful Thoracic Epidural Catheter Placement
Time frame: Maximum 20 minutes post administration of epidural test dose
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.
7 secondary outcomes
Amount of Time Required to Complete the Procedure
Time frame: During procedure, assessed up to 15 minutes
Number of Participants Who Reported Loss of Cold Sensation at Various Time Points
Time frame: Up to 20 minutes post administration of epidural test dose
Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure
Time frame: Up to 20 minutes post administration of epidural test dose
Number of Participants With Significant Change in Systolic Blood Pressure
Time frame: Up to 20 minutes post administration of epidural test dose
Number of Participants Whose Provider Answered "Yes" or "No" to Ease of Catheter Placement
Time frame: During procedure, assessed up to 15 minutes
Number of Participants With a Positive Meniscus Test
Time frame: During procedure, assessed up to 15 minutes
Number of Participants With Unintentional Dural Puncture
Time frame: During procedure, assessed up to 15 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 14612482Block 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.
- Results publication: PubMed 12218518Carli 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.
- Results publication: PubMed 18936379Popping 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.
- Results publication: 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.
- Results publication: PubMed 27922948Parra 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.
- Results publication: PubMed 25172504Gong 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.
- Derived from this study: PubMed 38190338Ranganath 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data (IPD) collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.
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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.
Yatish S Ranganath, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional (loss-of-resistance technique) thoracic epidural placement and CompuFlo thoracic epidural placement in people with Thoracic Epidural Anesthesia, run by YATISH SIDDAPURA RANGANATH 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 6 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: finished, as of the sponsor's last update on 19 Oct 2022. 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 19 Oct 2022). 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?
Number of Participants With Successful Thoracic Epidural Catheter Placement (time frame: Maximum 20 minutes post administration of epidural test dose). 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 NCT03826186, which also lists 7 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 19 Oct 2022.