Catheterization, PeripheralNCT03592602
Evaluate the Impact of Arm Abduction and Adduction on the Intravascular Electrocardiograph During PICC Placement and the Tip Location Changes Related to it
A study testing arm abduction and adduction in people with Catheterization, Peripheral and Catheterization, Central Venous, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The purpose of the study is to evaluate the impact of arm abduction and adduction on the intravascular electrocardiograph during PICC placement and to find out how arm position influences the catheter tip location by taking postprocedural chest X-ray radiographs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Peripheral, Catheterization, Central Venous
- What is being tested?
- arm abduction and adduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2018to 1 Nov 2018
- 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
- indication for PICC placement
- able to corporate with the operator during the procedure
- a recognizable P wave on basal ECG
Who cannot join
- bedside PICC placement
- Atrial fibrillation or other atrial arrhythmia's in which a P wave was not consistently present on ECG.
- with pacemaker
- unable to move to take post-procedural chest X-ray radiographs
- unable to move the punctured arm or can only move with limited angles due to anatomical abnormalities or personal/medical equipment or surgeries.
- catheter tip cannot be clearly visible on chest X-ray radiograph due to thoracic abnormalities or cardiothoracic surgeries.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Wei Gao, gaoweisdu@163.com
About this study
The purpose of the study is to evaluate the impact of arm abduction and adduction on the intravascular electrocardiograph during PICC placement and to find out how arm position influences the catheter tip location by taking postprocedural chest X-ray radiographs.
Read the detailed description
PICC has been widely applied for therapeutic and nutritional use. In the routine procedure of PICC placement, for better exposure of the punctured vein and a wider aseptic area, the PICC set is investigated with the patient's arm abducted in a supine position. While in actual use of the PICC line, patients commonly prefer a more comfortable position with arm adducted. Considering the incorporation of the arm position when the catheter is placed and being used, the effectiveness and safety of the PICC line with the punctured arm adducted are of practical importance.
This study aims to evaluate the impact of arm abduction and adduction on the intravascular electrocardiograph (ECG) during ECG-guided PICC placement and to explore how arm movement (from abduction to adduction) makes an influence on the catheter tip position.
This study is expected to enroll 150 participants. All participants would undergo the procedure of ECG-guided PICC placement. ECG data will be recorded before the procedure (basal ECG) and during the procedure with the punctured arm abducted and adducted. After the procedure, participants will take a post chest X-ray confirmation with arms adducted and abducted in a supine position. The catheter tip position and influences of arm movements will be calculated by the distances from the catheter tip to the carina on radiographs.
- Being tested
- arm abduction and adduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arm abduction and adductionProcedure or surgery
All PICC lines will be placed under the guidance of intravascular ECG. Before the PICC placement procedure, basal ECG will be examed. During the procedure, intravascular ECG data will be collected with the punctured arm adduction and abduction while the catheter advances to the cavoatrial junction. After the procedure, chest X-ray radiographs will be taken with arms 90° abducted and adducted (i.e., 0°abducted) in a supine position.
| Study group | Role | What they receive |
|---|---|---|
| arm movement | Experimental | Male or female patients, age ≥ 18, who meet the indication of PICC placement and be able to move the arm (abducted and adducted) with compliance will be studied. Receives: Procedure: arm abduction and adduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the intravenous ECG with the arm abducted and adducted during PICC placement.
Comparing the shape and amplitude of the p wave with the arm abducted and adducted.
Measured: Usually the procedure will take from 0-60 minutes.
Secondary outcomes (1)
Changes of the catheter tip position with the arm abducted and adducted.
Each patient will take two chest X-ray graphs with arms abducted and adducted respectively. Measuring distances from the catheter tip to the carina on radiographs.
Measured: Usually from 0-7 days after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start15 Jun 2018
- Primary completion15 Oct 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheterization, PeripheralStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592602
- Sponsor's protocol ID
- 26010105051802
- Status last verified
- Jul 2018
- First submitted
- 1 Jul 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Impact of Arm Abduction and Adduction on the Intravascular Electrocardiograph During PICC Placement and the Tip Location Changes Related to it
- ClinicalTrials.gov ID
- NCT03592602
- Acronym / sponsor ID
- 26010105051802
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Oct 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 19 Jul 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.
The purpose of the study is to evaluate the impact of arm abduction and adduction on the intravascular electrocardiograph during PICC placement and to find out how arm position influences the catheter tip location by taking postprocedural chest X-ray radiographs.
Detailed description
PICC has been widely applied for therapeutic and nutritional use. In the routine procedure of PICC placement, for better exposure of the punctured vein and a wider aseptic area, the PICC set is investigated with the patient's arm abducted in a supine position. While in actual use of the PICC line, patients commonly prefer a more comfortable position with arm adducted. Considering the incorporation of the arm position when the catheter is placed and being used, the effectiveness and safety of the PICC line with the punctured arm adducted are of practical importance.
This study aims to evaluate the impact of arm abduction and adduction on the intravascular electrocardiograph (ECG) during ECG-guided PICC placement and to explore how arm movement (from abduction to adduction) makes an influence on the catheter tip position.
This study is expected to enroll 150 participants. All participants would undergo the procedure of ECG-guided PICC placement. ECG data will be recorded before the procedure (basal ECG) and during the procedure with the punctured arm abducted and adducted. After the procedure, participants will take a post chest X-ray confirmation with arms adducted and abducted in a supine position. The catheter tip position and influences of arm movements will be calculated by the distances from the catheter tip to the carina on radiographs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm movement | Experimental | Procedure: arm abduction and adductionMale or female patients, age ≥ 18, who meet the indication of PICC placement and be able to move the arm (abducted and adducted) with compliance will be studied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- indication for PICC placement
- able to corporate with the operator during the procedure
- a recognizable P wave on basal ECG
Key exclusion criteria (6 listed)
- bedside PICC placement
- Atrial fibrillation or other atrial arrhythmia's in which a P wave was not consistently present on ECG.
- with pacemaker
- unable to move to take post-procedural chest X-ray radiographs
- unable to move the punctured arm or can only move with limited angles due to anatomical abnormalities or personal/medical equipment or surgeries.
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 |
|---|---|---|
| arm abduction and adductionAll PICC lines will be placed under the guidance of intravascular ECG. Before the PICC placement procedure, basal ECG will be examed. During the procedure, intravascular ECG data will be collected with the punctured arm adduction and abduction while the catheter advances to the cavoatrial junction. After the procedure, chest X-ray radiographs will be taken with arms 90° abducted and adducted (i.e., 0°abducted) in a supine position. | Procedure or surgery | arm movement |
Primary outcome
Changes of the intravenous ECG with the arm abducted and adducted during PICC placement.
Time frame: Usually the procedure will take from 0-60 minutes.
Comparing the shape and amplitude of the p wave with the arm abducted and adducted.
1 secondary outcome
Changes of the catheter tip position with the arm abducted and adducted.
Time frame: Usually from 0-7 days after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arm abduction and adduction in people with Catheterization, Peripheral and Catheterization, Central Venous, run by Qilu Hospital of Shandong 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 6 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 19 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Gao (+8617753101262, gaoweisdu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the intravenous ECG with the arm abducted and adducted during PICC placement. (time frame: Usually the procedure will take from 0-60 minutes.). 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 19 Jul 2018.