Central Venous CathetersNCT03778437
Facilitating Needle Alignment With Aiming Method
A study testing subclavian vein catheterization, landmark techniques and Ultrasound-guided plus needle guide techniques in people with Central Venous Catheters, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Although ultrasound-guided catheterization of the subclavian vein is becoming standard procedure in anesthetic practice, failure to align the needle and the transducer still can lead to possibly complications. In this study, we proposed a new alignment method, namely Aiming Method. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Central Venous Catheters
- What is being tested?
- subclavian vein catheterization, landmark techniques and Ultrasound-guided plus needle guide techniques
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2019to 27 Dec 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years to 70 years
- American Society of Anesthesiologists (ASA) Physical Status Ⅰ-Ⅲ
- Elective surgery patients requiring subclavian vein catheterization
Who cannot join
- Local anatomic abnormalities in subclavicular area
- Preexisting subclavian vein thrombosis or coagulation disorders
- Refusal of subclavian vein catheterization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aiming Method May Facilitate Needle Alignment in Ultrasound-guided Subclavian Vein Catheterization
Although ultrasound-guided catheterization of the subclavian vein is becoming standard procedure in anesthetic practice, failure to align the needle and the transducer still can lead to possibly complications. In this study, we proposed a new alignment method, namely Aiming Method. The purpose of this study is to investigate whether the use of this aiming method improved resident volunteers' performance of ultrasound-guided SC insertion in real patients. Specifically, residents were asked to perform three different methods: landmark techniques, ultrasound-guided with aiming method and ultrasound-guided plus needle guide techniques.
- Conditions
- Central Venous Catheters
- Being tested
- subclavian vein catheterization, landmark techniques, Ultrasound-guided plus needle guide techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subclavian vein catheterizationProcedure or surgery
Here we introduced a new freehand method, named as Aiming Method, which facilitated the alignment of injection needles with ultrasound beams. During this aiming method, patient is still positioned in Tredelenburg with the arm abducted to 90° and no needle guidance will be used.
landmark techniquesProcedure or surgery
The patient is positioned in Tredelenburg with the arm abducted to 90°. Venipuncture should occur 1 cm lateral to the curvature of the middle third of the clavicle with the needle pointing horizontally directed at the sternal notch. If subclavian vein is missing at the first try, withdraw the needle and direct horizontally at the cricoid cartilage at the second try.
Ultrasound-guided plus needle guide techniquesProcedure or surgery
Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique. The patient is positioned in Tredelenburg with the arm abducted to 90°. During the needle insertion, the needle is secured in the needle guidance device which keeps the alignment of needle and ultrasonic beam.
| Study group | Role | What they receive |
|---|---|---|
| landmark techniques | Active comparator | Subclavian vein catheterization is performed without the guidance of ultrasound. The needle was inserted 1 cm inferior and 1 cm lateral to the junction of the middle and medial thirds of the clavicle (infraclavicular approach) Receives: Procedure: landmark techniques |
| ultrasound-guided with aiming method | Experimental | Subclavian vein catheterization is performed with our newly proposed aiming method with the guidance of ultrasound. Receives: Procedure: subclavian vein catheterization |
| ultrasound-guided plus needle guide techniques | Experimental | Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique. Receives: Procedure: Ultrasound-guided plus needle guide techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural time
the time from skin break to guide wire was positioned into the subclavian vein
Measured: 24 hours
Number of skin breaks
number of skin punctures
Measured: 24 hours
Secondary outcomes (2)
The incidence of arterial puncture
aspiration of arterial blood during needle insertion or local haematoma in ultrasound image
Measured: 24 hours
The incidence of pneumothorax
aspiration of air during needle insertion, or thoracic ultrasonography, or chest radiography
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start12 Feb 2019
- Primary completion20 Dec 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CathetersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingxiang Mao, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778437
- Sponsor's protocol ID
- 2018(45)
- Status last verified
- Sep 2020
- First submitted
- 3 Dec 2018
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aiming Method May Facilitate Needle Alignment in Ultrasound-guided Subclavian Vein Catheterization
- ClinicalTrials.gov ID
- NCT03778437
- Acronym / sponsor ID
- 2018(45)
- Conditions
- Central Venous Catheters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 19 Dec 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.
Although ultrasound-guided catheterization of the subclavian vein is becoming standard procedure in anesthetic practice, failure to align the needle and the transducer still can lead to possibly complications. In this study, we proposed a new alignment method, namely Aiming Method. The purpose of this study is to investigate whether the use of this aiming method improved resident volunteers' performance of ultrasound-guided SC insertion in real patients. Specifically, residents were asked to perform three different methods: landmark techniques, ultrasound-guided with aiming method and ultrasound-guided plus needle guide techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| landmark techniques | Active comparator | Procedure: landmark techniquesSubclavian vein catheterization is performed without the guidance of ultrasound. The needle was inserted 1 cm inferior and 1 cm lateral to the junction of the middle and medial thirds of the clavicle (infraclavicular approach) |
| ultrasound-guided with aiming method | Experimental | Procedure: subclavian vein catheterizationSubclavian vein catheterization is performed with our newly proposed aiming method with the guidance of ultrasound. |
| ultrasound-guided plus needle guide techniques | Experimental | Procedure: Ultrasound-guided plus needle guide techniquesSubclavian vein catheterization is performed under ultrasound guidance with in-plane technique. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years to 70 years
- American Society of Anesthesiologists (ASA) Physical Status Ⅰ-Ⅲ
- Elective surgery patients requiring subclavian vein catheterization
Key exclusion criteria (3 listed)
- Local anatomic abnormalities in subclavicular area
- Preexisting subclavian vein thrombosis or coagulation disorders
- Refusal of subclavian vein catheterization
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 |
|---|---|---|
| subclavian vein catheterizationHere we introduced a new freehand method, named as Aiming Method, which facilitated the alignment of injection needles with ultrasound beams. During this aiming method, patient is still positioned in Tredelenburg with the arm abducted to 90° and no needle guidance will be used. | Procedure or surgery | ultrasound-guided with aiming method |
| landmark techniquesThe patient is positioned in Tredelenburg with the arm abducted to 90°. Venipuncture should occur 1 cm lateral to the curvature of the middle third of the clavicle with the needle pointing horizontally directed at the sternal notch. If subclavian vein is missing at the first try, withdraw the needle and direct horizontally at the cricoid cartilage at the second try. | Procedure or surgery | landmark techniques |
| Ultrasound-guided plus needle guide techniquesSubclavian vein catheterization is performed under ultrasound guidance with in-plane technique. The patient is positioned in Tredelenburg with the arm abducted to 90°. During the needle insertion, the needle is secured in the needle guidance device which keeps the alignment of needle and ultrasonic beam. | Procedure or surgery | ultrasound-guided plus needle guide techniques |
Primary outcome
Procedural time
Time frame: 24 hours
the time from skin break to guide wire was positioned into the subclavian vein
Number of skin breaks
Time frame: 24 hours
number of skin punctures
2 secondary outcomes
The incidence of arterial puncture
Time frame: 24 hours
The incidence of pneumothorax
Time frame: 24 hours
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 23 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subclavian vein catheterization, landmark techniques and Ultrasound-guided plus needle guide techniques in people with Central Venous Catheters, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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 3 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 23 Sep 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 China. 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?
Procedural time (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 23 Sep 2020.