AnesthesiaSHERLOCK 3CGNCT01969981
A Study to Assess Placement and Confirmation of Peripheral Inserted Central Catheters Tip Position Using a New Electrocardiographic Method
An observational study of Anesthesia and Intravenous, run by Centre Leon Berard at 1 site in France.
Trial summary
This is a prospective, single center, observational study. Patients who require a Peripheral Inserted Central Catheters (PICC) will constitute the study population. The purpose of the study is to determine whether Sherlock 3CG, is adequate means for the total placement of PICC and confirmation of tip of PICC placement… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Intravenous
- What is being tested?
- PICC placement with Sherlock 3CG
- Type of treatment
- Surgery or procedure
- How many people
- 571 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Apr 2014
- Phase
- Observational
- 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
Study population: Patients will be included as well as they are ambulatory or hospitalized in Centre Leon Berard.
Who may be able to join
- 18 years-old patient or older,
- Patient requiring PICC placement in the vascular access unit,
- Patient able to read and understand the French language,
- Patient affiliated with a social security system.
Who cannot join
- Any contraindication to PICC insertion,
- Patient unable to lie in the supine position
- Patient with a Body Mass Index > 40
- Any medical condition that could change the normal presentation of the P-wave such as arrhythmia, atrial flutter, pace maker with permanent stimulation…
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational, Prospective, Single-center Study of Placement and Confirmation of Peripheral Inserted Central Catheters Tip Position Using a New Electrocardiographic Method
This is a prospective, single center, observational study. Patients who require a Peripheral Inserted Central Catheters (PICC) will constitute the study population.
The purpose of the study is to determine whether Sherlock 3CG, is adequate means for the total placement of PICC and confirmation of tip of PICC placement and if this method can be conducted safely and efficiently.
Read more
Patients will be included during a 6-month period as well as they are ambulatory or hospitalized. The patient's routine care will not be modified and only PICC will be assessed in the present study.
PICC placement will be performed using the Site Rite guidance and tip position will be confirmed using the Sherlock 3CG.
The procedure is the same as the routine habits of the operator (nurse or anesthesiologist); the vascular access team already uses the previous device for CVC placement.
Patients won't be followed up in the study.
Read the detailed description
Our current Central Venous Catheter placement protocol for PICC includes the resort to UltraSonography (US) and requires fluoroscopy and plain radiographies throughout the PICC insertion and until the confirmation of best placement.
This verification is mandatory to avoid the risks, delays and costs of repositioning the tip, but obtaining a fluoroscopy and plain radiographies in operating rooms can be time consuming and exposes the patient, nurses and physicians to radiations.
The use of endocavitary electrocardiogram for tip position confirmation has been developed since 1985 and is now recognized as an alternative method. It has been recognized as the best technique in other indications, such as hemodialysis. It helps to position PICC tip in proximity to the cavoatrial junction. In Europe, Italian and German teams already use this new method.
A new ultrasound machine offering external sensors and Endocavitary ECG guide is now available (Site Rite and Sherlock 3CG - Tip Confirmation System), which allows the installation and proper placement in the same operation. This Sherlock 3CG TCS has already been approved by the Food and Drug Administration in the US and is indicated for PICC tip placement confirmation in adult patients.
This new ECG guidance method will allow the PICC insertion without any radiation in the operating room.
For the moment, according to the local recommendations, French patients will have to continue to perform one post-procedural X-ray to confirm tip position. This exam will be performed in a dedicated room of the radiology unit. But guidance and confirmation of CVC placement only by ECG may provide a faster means of confirmation and eliminates radiation exposure to the patients, nurses and anesthesiologists.
In addition, it would eliminate the costs associated with confirmatory chest X-ray (exam costs and time consumption).
- Conditions
- Anesthesia, Intravenous
- Being tested
- PICC placement with Sherlock 3CG
- Keywords
- Peripheral Inserted Central Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICC placement with Sherlock 3CGProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PICC placement | Not described Receives: Procedure: PICC placement with Sherlock 3CG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of PICC placement using the Sherlock 3CG
Success rate of PICC placement (no need to use radiation or fluoroscopy before the end of the procedure)
Measured: During the procedure (Day 0)
Secondary outcomes (8)
Assess the number of punctures in brachial site
Efficacy of needle guide
Measured: During the procedure (Day 0)
Assess the unique punction rate
Measured: During the procedure (Day 0)
Assess the number of repositions after procedure closed
Measured: During the procedure (Day 0)
Assess pain
By means of a Verbal Numeric Scale
Measured: During the procedure (Day 0)
Assess acute complications rate
Hemothorax, arterial puncture, etc.
Measured: During the procedure (Day 0)
Assess the percentage of patients requiring fluoroscopy
Measured: During the procedure (Day 0)
Assess the final radiation rate
When applicable
Measured: During the procedure (Day 0)
Assess the percentage of patients with good placement on the X-Ray
Measured: During the procedure (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé ROSAY, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969981
- Sponsor's protocol ID
- SHERLOCK 3CG
- Other IDs
- 1626789
- Acronym
- SHERLOCK 3CG
- Status last verified
- Sep 2014
- First submitted
- 22 Oct 2013
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective, Single-center Study of Placement and Confirmation of Peripheral Inserted Central Catheters Tip Position Using a New Electrocardiographic Method
- ClinicalTrials.gov ID
- NCT01969981
- Acronym / sponsor ID
- SHERLOCK 3CG / SHERLOCK 3CG
- Conditions
- Anesthesia, Intravenous
- Keywords
- Peripheral Inserted Central Catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Oct 2013 (estimated)
- 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.
This is a prospective, single center, observational study. Patients who require a Peripheral Inserted Central Catheters (PICC) will constitute the study population.
The purpose of the study is to determine whether Sherlock 3CG, is adequate means for the total placement of PICC and confirmation of tip of PICC placement and if this method can be conducted safely and efficiently.
Patients will be included during a 6-month period as well as they are ambulatory or hospitalized. The patient's routine care will not be modified and only PICC will be assessed in the present study.
PICC placement will be performed using the Site Rite guidance and tip position will be confirmed using the Sherlock 3CG.
The procedure is the same as the routine habits of the operator (nurse or anesthesiologist); the vascular access team already uses the previous device for CVC placement.
Patients won't be followed up in the study.
Detailed description
Our current Central Venous Catheter placement protocol for PICC includes the resort to UltraSonography (US) and requires fluoroscopy and plain radiographies throughout the PICC insertion and until the confirmation of best placement.
This verification is mandatory to avoid the risks, delays and costs of repositioning the tip, but obtaining a fluoroscopy and plain radiographies in operating rooms can be time consuming and exposes the patient, nurses and physicians to radiations.
The use of endocavitary electrocardiogram for tip position confirmation has been developed since 1985 and is now recognized as an alternative method. It has been recognized as the best technique in other indications, such as hemodialysis. It helps to position PICC tip in proximity to the cavoatrial junction. In Europe, Italian and German teams already use this new method.
A new ultrasound machine offering external sensors and Endocavitary ECG guide is now available (Site Rite and Sherlock 3CG - Tip Confirmation System), which allows the installation and proper placement in the same operation. This Sherlock 3CG TCS has already been approved by the Food and Drug Administration in the US and is indicated for PICC tip placement confirmation in adult patients.
This new ECG guidance method will allow the PICC insertion without any radiation in the operating room.
For the moment, according to the local recommendations, French patients will have to continue to perform one post-procedural X-ray to confirm tip position. This exam will be performed in a dedicated room of the radiology unit. But guidance and confirmation of CVC placement only by ECG may provide a faster means of confirmation and eliminates radiation exposure to the patients, nurses and anesthesiologists.
In addition, it would eliminate the costs associated with confirmatory chest X-ray (exam costs and time consumption).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICC placement | – | Procedure: PICC placement with Sherlock 3CG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be included as well as they are ambulatory or hospitalized in Centre Leon Berard.
Key inclusion criteria (4 listed)
- 18 years-old patient or older,
- Patient requiring PICC placement in the vascular access unit,
- Patient able to read and understand the French language,
- Patient affiliated with a social security system.
Key exclusion criteria (4 listed)
- Any contraindication to PICC insertion,
- Patient unable to lie in the supine position
- Patient with a Body Mass Index > 40
- Any medical condition that could change the normal presentation of the P-wave such as arrhythmia, atrial flutter, pace maker with permanent stimulation…
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 |
|---|---|---|
| PICC placement with Sherlock 3CG | Procedure or surgery | PICC placement |
Primary outcome
Efficacy of PICC placement using the Sherlock 3CG
Time frame: During the procedure (Day 0)
Success rate of PICC placement (no need to use radiation or fluoroscopy before the end of the procedure)
8 secondary outcomes
Assess the number of punctures in brachial site
Time frame: During the procedure (Day 0)
Assess the unique punction rate
Time frame: During the procedure (Day 0)
Assess the number of repositions after procedure closed
Time frame: During the procedure (Day 0)
Assess pain
Time frame: During the procedure (Day 0)
Assess acute complications rate
Time frame: During the procedure (Day 0)
Assess the percentage of patients requiring fluoroscopy
Time frame: During the procedure (Day 0)
Assess the final radiation rate
Time frame: During the procedure (Day 0)
Assess the percentage of patients with good placement on the X-Ray
Time frame: During the procedure (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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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.
Hervé ROSAY, MD principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Intravenous, run by Centre Leon Berard at 1 site in France.
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 4 inclusion and 4 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 12 Sep 2014. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of PICC placement using the Sherlock 3CG (time frame: During the procedure (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2014.