Central Line ComplicationiECGNCT03697291
Self-invented Intracavitary ECG Wire VS the Commercial System - Certodyn®
A study testing PS wire in people with Central Line Complication, run by Mahidol University at 2 sites in Thailand.
Trial summary
Peripherally Inserted Central Catheter (PICC) is considered a central venous line placement (CVL) which mandates the confirmation of the tip's location. At present, most CVL's position are confirmed by radiographic method either by in-procedure fluoroscopy or post-insertion x-ray. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Line Complication
- What is being tested?
- PS wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Aug 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age 18 years and above.
- Requires PICC line insertion from upper torso.
Who cannot join
- Children younger than 18 years.
- Patient with atrial fibrillation or other rhythms not generated from intrinsic SA node i.e. pacer, atrial fibrillation, etc.
- Unstable hemodynamic.
- Patient with history arrhythmias.
- Patient with HR > 120 bpm.
- Patients with hypercoagulable state.
Show all 9Show fewer
- Allergy to heparin.
- Patients with known heparin induced thrombocytopenia.
- Patients with known Creutzfeldt-Jakob Disease.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital
Bangkok, 10700
Prasert Sawasdiwipachai, MD, 6624113256, sipswp@mahidol.ac.rh
Sirilak Suksompong, MD, 6624113256, sirilak.suk@mahidol.ac.th
- Recruiting
Siriraj hospital, Mahidol university
Bangkok Noi, Bangkok, 10700
Prasert Sawasdiwipachai, MD, Vithaya, vithayac@gmail.com
Vithaya Chaithiraphan, MD, 66874147408, vithayac@gmail.com
About this study
Official title: Comparison of the Self-invented Intracavitary ECG Wire With the Commercial System - Certodyn®
Peripherally Inserted Central Catheter (PICC) is considered a central venous line placement (CVL) which mandates the confirmation of the tip's location. At present, most CVL's position are confirmed by radiographic method either by in-procedure fluoroscopy or post-insertion x-ray. For CVLs placed from upper body (from internal jugular vein, subclavian veins or upper arm veins), the intracavitary electrocardiogram (iECG) can also be used.
Intracavitary ECG are proven effective for tip confirmation and provide some benefits i.e. lower cost, decrease exposure to harmful radiation for care providers and also the patients, require less personals and equipments, provide real-time confirmation as comparable to fluoroscopy, etc. There are several devices and makes of iECG apparatus but B.Braun-Certodyn® remains the only available system in our institution. The limitation is the availability of the Certodyn devices on each locations where CVL will be placed i.e. operating theater, intensive care unit, bedside placement, radiology suite, etc. Since the connecting wire is only supplied in the certain CVL kits under B.Braun brand, this has rendered iECG for other types or makes of CVL or PICC line become even more difficult.
Self-invented connector wire for iECG (PS wire) has been made and used effectively in the past few years at Siriraj hospital. The patent registration is underway and the author seek to compare this PS wire against the commercial Certodyn system.
Read the detailed description
Objective
- To evaluate the success rate of iECG CVL tip confirmation by self-invented iECG connector wire.
- To compare quality of iECG tracing produced from both of self-invented iECG wire versus the Certodyn system.
Materials, participants and study method
Equipments required:
- Self-invented iECG wire (PS wire) 2) Commercial iECG system which consists of the Certodyn and the wire. 3) Standard ECG monitoring system which can display and printout the ECG tracing. 4) A digital ECG caliper which can measure P wave amplitude and noise segment in millimeter up to 2 decimal points. Study method
- Patient presented for PICC line from upper torso will be screened and assessed for eligibility.
- Exclusion criteria includes children younger than 18 yo, patient with atrial fibrillation or other rhythms not generated from intrinsic SA node i.e. pacer, unstable hemodynamic, patient with history arrhythmias, HR > 120 bpm, patients with hypercoagulable state, allergy to heparin or patients with known heparin induced thrombocytopenia, patients with known Creutzfeldt-Jakob Disease
- Obtain informed consent.
- Patient will be monitored with standard 3-lead ECG, the baseline lead II ECG will be printed out and tagged with a serial number.
- Patient will undergo the standard PICC line placement using Seldinger or modified Seldinger technique. The catheter will be pre-flushed with 10 units/mL heparinized NSS. When catheter is inserted into the proximal SVC (guided by landmark measurement), the wire will be retracted to the marked location where the tip of the wire is at the end of the catheter. The iECG connection by Certodyn will be applied. The catheter and wire will be adjusted until the giant P wave (highest P) was detected on screen, this ECG tracing will be printed out and tagged with another non-sequential serial number. The iECG will then switched to the PS wire and the iECG tracing will be printed out again and tagged with another non-sequential serial number. All 3 ECG printouts will be stapled together for measurement by cardiologist who is blind to the intervention later.
- The intervention related to research study is considered ended at this point. The patient will have their CVL/PICC line adjusted to the proper position (mid to distal SVC for mid-long term and long term catheter). The CVL or PICC will be secured, flushed and locked per standard protocol.
- Portable CXR will be routinely obtained when patients arrived to the ward. The information of the tip of the catheter will be recorded as well.
Data analysis
- Demographic data, type of catheter, depth of catheter where giant P wave obtained and final position of catheter will be recorded.
- Each study patient produce 3 ECG print outs which are -baseline surface lead II ECG
- iECG produced by Certodyn system
- iECG produced by PS wire Each ECG tracing will be evaluated and measured by a cardiologist who is blind to the intervention. The 2 measured parameters includes:
- The amplitude of P wave in mm from baseline surface ECG of each cardiac cycle. -The amplitude of giant P wave in mm from iECG from both Certodyn and PS wire.
- All 3 ECG print outs will be compared for quality and the length noisy ECG segment (determined as the ECG with interference artifact of baseline > 1 mm) will also be measured in mm.
- All measurement will be analyzed statistically to determine the differences between the 2 systems.
- Conditions
- Central Line Complication
- Being tested
- PS wire
- Keywords
- Self invented iECG wire, PS wire, Certodyn, intracavitary ECG, PICC line, giant P wave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS wireDevice
Also called Self-invented iECG wire
The wiring connection used to convey ECG signal from inside the body
| Study group | Role | What they receive |
|---|---|---|
| PS wire | Experimental | self-invented iECG wire Receives: Device: PS wire |
| Certodyn | Active comparator | Commercially available iECG system - Certodyn Receives: Device: PS wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal noise ratio
Measuring the segment of ECG noise (if exists) in millimeters compare to the total ECG segment. Compare this signal noise ratio between the baseline surface ECG, the self-invented wire derived iECG and the Certodyn derived iECG.
Measured: 10 minutes
Secondary outcomes (1)
The amplitude of giant P Wave
Measure the amplitude of each giant P wave obtained from ECG print out from iECG derived from both certodyn and self-invented iECG wire.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start1 Aug 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Line ComplicationStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Single center, prospective, cross over study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prasert Sawasdiwipachai, Mahidol University
- Investigators
- Prasert Sawasdiwipachai, MD, Principal investigator, Anesthesiology department Siriraj hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697291
- Sponsor's protocol ID
- Si 548/2018
- Acronym
- iECG
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1. Oster, D.D. "Improving ECG trace quality." Biomedical Instrumentation & Technology, 2000; 34: 219-222. 2. Corsten SA, van Dijk B, Bakker NC, de Lange JJ, Scheffer GJ. Central venous catheter placement using the ECG-guided Cavafix-Certodyn SD catheter. J Clin Anesth. 1994; 6(6): 469-72. 3. Pittiruti M, La Greca A, Scoppettuolo G. The electrocardiographic method for positioning the tip of central venous catheters. J Vasc Access. 2011; 12(4): 280-91. 4. Pittiruti M, Bertollo D, Briglia E, Buononato M, Capozzoli G, De Simone L, La Greca A, Pelagatti C, Sette P. The intracavitory ECG method for positioning the tip of central venous catheters: results of an italian multicenter study. J Vasc Access. 2012; 13(3):357-65. 5. Wang G, Guo L, Jiang B, Huang M, Zhang J, Qin Y. Factors Influencing Intracavitory Electrocardiographic P-Wave Changes during Central Venous Catheter Placement. PLoS One. 201510(4):e0124846. 6. Yuan L, Li R, Meng A, Feng Y, Wu X, Yang Y, et al. Superior success rate of intracavitory electrocardiogram guidance for peripherally inserted central catheter placement in patients with cancer: A randomized open-label controlled multi center study. PLoO One. 2017; 12(3):e0171630.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Self-invented Intracavitary ECG Wire With the Commercial System - Certodyn®
- ClinicalTrials.gov ID
- NCT03697291
- Acronym / sponsor ID
- iECG / Si 548/2018
- Conditions
- Central Line Complication
- Keywords
- Self invented iECG wire, PS wire, Certodyn, intracavitary ECG, PICC line, giant P wave
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripherally Inserted Central Catheter (PICC) is considered a central venous line placement (CVL) which mandates the confirmation of the tip's location. At present, most CVL's position are confirmed by radiographic method either by in-procedure fluoroscopy or post-insertion x-ray. For CVLs placed from upper body (from internal jugular vein, subclavian veins or upper arm veins), the intracavitary electrocardiogram (iECG) can also be used.
Intracavitary ECG are proven effective for tip confirmation and provide some benefits i.e. lower cost, decrease exposure to harmful radiation for care providers and also the patients, require less personals and equipments, provide real-time confirmation as comparable to fluoroscopy, etc. There are several devices and makes of iECG apparatus but B.Braun-Certodyn® remains the only available system in our institution. The limitation is the availability of the Certodyn devices on each locations where CVL will be placed i.e. operating theater, intensive care unit, bedside placement, radiology suite, etc. Since the connecting wire is only supplied in the certain CVL kits under B.Braun brand, this has rendered iECG for other types or makes of CVL or PICC line become even more difficult.
Self-invented connector wire for iECG (PS wire) has been made and used effectively in the past few years at Siriraj hospital. The patent registration is underway and the author seek to compare this PS wire against the commercial Certodyn system.
Detailed description
Objective
- To evaluate the success rate of iECG CVL tip confirmation by self-invented iECG connector wire.
- To compare quality of iECG tracing produced from both of self-invented iECG wire versus the Certodyn system.
Materials, participants and study method
Equipments required:
- Self-invented iECG wire (PS wire) 2) Commercial iECG system which consists of the Certodyn and the wire. 3) Standard ECG monitoring system which can display and printout the ECG tracing. 4) A digital ECG caliper which can measure P wave amplitude and noise segment in millimeter up to 2 decimal points. Study method
- Patient presented for PICC line from upper torso will be screened and assessed for eligibility.
- Exclusion criteria includes children younger than 18 yo, patient with atrial fibrillation or other rhythms not generated from intrinsic SA node i.e. pacer, unstable hemodynamic, patient with history arrhythmias, HR > 120 bpm, patients with hypercoagulable state, allergy to heparin or patients with known heparin induced thrombocytopenia, patients with known Creutzfeldt-Jakob Disease
- Obtain informed consent.
- Patient will be monitored with standard 3-lead ECG, the baseline lead II ECG will be printed out and tagged with a serial number.
- Patient will undergo the standard PICC line placement using Seldinger or modified Seldinger technique. The catheter will be pre-flushed with 10 units/mL heparinized NSS. When catheter is inserted into the proximal SVC (guided by landmark measurement), the wire will be retracted to the marked location where the tip of the wire is at the end of the catheter. The iECG connection by Certodyn will be applied. The catheter and wire will be adjusted until the giant P wave (highest P) was detected on screen, this ECG tracing will be printed out and tagged with another non-sequential serial number. The iECG will then switched to the PS wire and the iECG tracing will be printed out again and tagged with another non-sequential serial number. All 3 ECG printouts will be stapled together for measurement by cardiologist who is blind to the intervention later.
- The intervention related to research study is considered ended at this point. The patient will have their CVL/PICC line adjusted to the proper position (mid to distal SVC for mid-long term and long term catheter). The CVL or PICC will be secured, flushed and locked per standard protocol.
- Portable CXR will be routinely obtained when patients arrived to the ward. The information of the tip of the catheter will be recorded as well.
Data analysis
- Demographic data, type of catheter, depth of catheter where giant P wave obtained and final position of catheter will be recorded.
- Each study patient produce 3 ECG print outs which are -baseline surface lead II ECG
- iECG produced by Certodyn system
- iECG produced by PS wire Each ECG tracing will be evaluated and measured by a cardiologist who is blind to the intervention. The 2 measured parameters includes:
- The amplitude of P wave in mm from baseline surface ECG of each cardiac cycle. -The amplitude of giant P wave in mm from iECG from both Certodyn and PS wire.
- All 3 ECG print outs will be compared for quality and the length noisy ECG segment (determined as the ECG with interference artifact of baseline > 1 mm) will also be measured in mm.
- All measurement will be analyzed statistically to determine the differences between the 2 systems.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, prospective, cross over study
| Arm | Type | Receives |
|---|---|---|
| PS wire | Experimental | Device: PS wireself-invented iECG wire |
| Certodyn | Active comparator | Device: PS wireCommercially available iECG system - Certodyn |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient age 18 years and above.
- Requires PICC line insertion from upper torso.
Key exclusion criteria (9 listed)
- Children younger than 18 years.
- Patient with atrial fibrillation or other rhythms not generated from intrinsic SA node i.e. pacer, atrial fibrillation, etc.
- Unstable hemodynamic.
- Patient with history arrhythmias.
- Patient with HR > 120 bpm.
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 |
|---|---|---|
| PS wireAlso: Self-invented iECG wireThe wiring connection used to convey ECG signal from inside the body | Device | Certodyn, PS wire |
Primary outcome
Signal noise ratio
Time frame: 10 minutes
Measuring the segment of ECG noise (if exists) in millimeters compare to the total ECG segment. Compare this signal noise ratio between the baseline surface ECG, the self-invented wire derived iECG and the Certodyn derived iECG.
1 secondary outcome
The amplitude of giant P Wave
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Background1. Oster, D.D. "Improving ECG trace quality." Biomedical Instrumentation & Technology, 2000; 34: 219-222. 2. Corsten SA, van Dijk B, Bakker NC, de Lange JJ, Scheffer GJ. Central venous catheter placement using the ECG-guided Cavafix-Certodyn SD catheter. J Clin Anesth. 1994; 6(6): 469-72. 3. Pittiruti M, La Greca A, Scoppettuolo G. The electrocardiographic method for positioning the tip of central venous catheters. J Vasc Access. 2011; 12(4): 280-91. 4. Pittiruti M, Bertollo D, Briglia E, Buononato M, Capozzoli G, De Simone L, La Greca A, Pelagatti C, Sette P. The intracavitory ECG method for positioning the tip of central venous catheters: results of an italian multicenter study. J Vasc Access. 2012; 13(3):357-65. 5. Wang G, Guo L, Jiang B, Huang M, Zhang J, Qin Y. Factors Influencing Intracavitory Electrocardiographic P-Wave Changes during Central Venous Catheter Placement. PLoS One. 201510(4):e0124846. 6. Yuan L, Li R, Meng A, Feng Y, Wu X, Yang Y, et al. Superior success rate of intracavitory electrocardiogram guidance for peripherally inserted central catheter placement in patients with cancer: A randomized open-label controlled multi center study. PLoO One. 2017; 12(3):e0171630.
- Individual participant dataSharing planned: Undecided
Related trials for Central Line Complication
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
RecruitingObservational study
Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections
Neonatal Infection
RecruitingPhase 1
Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Ovarian Cancer, HGSOC
RecruitingPhase 3
A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)
Endometrial Cancer
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.
Prasert Sawasdiwipachai, MD principal investigator
Anesthesiology department Siriraj hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS wire in people with Central Line Complication, run by Mahidol University at 2 sites in Thailand.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prasert Sawasdiwipachai, MD (66874147409, prasert.saw@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal noise ratio (time frame: 10 minutes). 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 NCT03697291, which also lists 1 linked publication.
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 9 Oct 2018.