Central Line ComplicationNCT05140668
Comparison Between Supraclavicular And Infraclavicular Approach For Right Subclavian Venous Catheterization
A study testing Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization in people with Central Line Complication, run by Sohag University at 1 site in Egypt.
Trial summary
A central venous catheter (CVC) is an indwelling device that is peripherally inserted into a larg central vein for a multitude of indications in major elective surgeries and ICU patients and now it's now with notable advance is the adjunct of ultrasound guidance, which has recently become the standard of care for CVCs… Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Line Complication
- What is being tested?
- Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2021to 8 Apr 2022
- 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 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patient refusel Irritable patient Infection at the puncture site medical devices (chemoport, pacemaker,etc.) at the puncture site. right subclavian venous thrombosis haemostatic disorders current anticoagulant medication prescriptions previous history of surgery that might distort the anatomy of the right subclavian vein.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization In Major Elective Surgeries And ICU Patients
A central venous catheter (CVC) is an indwelling device that is peripherally inserted into a larg central vein for a multitude of indications in major elective surgeries and ICU patients and now it's now with notable advance is the adjunct of ultrasound guidance, which has recently become the standard of care for CVCs placed in wanted site to decreases the complications
Read the detailed description
A central venous catheter (CVC) is an indwelling device that is peripherally inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium.for a multitude of indications including; total parenteral nutrition administration dialysis, plasmapheresis , medication administration, hemodynamic monitoring and to facilitate further complex interventions such as transvenous pacemaker placement inserted with Seldinger's technique. A notable advance is the adjunct of ultrasound guidance, which has recently become the standard of care for CVCs placed in wanted site owing to associated decreases in complications e.g. arterial puncture, haematoma formation, pneumothorax, haemothorax and catheterization failure and an increase in first-pass success.
- Conditions
- Central Line Complication
- Being tested
- Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous CatheterizationDevice
Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular central venous catheterization approach group | Active comparator | supraclavicular central venous catheterization group catheter is inserted in supraclavicular fossa (an indentation immediately above the clavicle) with a long-axis in plane approach Receives: Device: Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization |
| Infraclavicular central venous catheterization approach group | Active comparator | infraclavicular central venous catheterization group catheter is inserted in infraclavicular fossa (an indentation, immediately below the clavicle, above the third rib and between the deltoid muscle laterally and medioclavicular line medially) with a short-axis out-of-plane approach Receives: Device: Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare between the Supraclavicular and infraclavicular approach in right subclavian vein catheterization as regard accessibility sonar guided and number of punctures which is needed and the time of the procedure
After successful venous puncture, catheterization was attempted with the Seldinger's technique The guidewire and dilator were inserted to a depth of 10-15 cm and to the depth of venous puncture, respectively.
We considered an attempt at catheterization as 'failed' if successful catheterization was not achieved within 3 min or If an anesthetist failed to catheterize the patient successfully within three attempts in 210 patients
Measured: 7 months
Secondary outcomes (1)
to compare complications which result from supraclavicular or approaches for right subclavian venous catheter insertion
monitoring of complications which can result from any of the two approaches e.g. arterial puncture, haematoma formation, pneumothorax, haemothorax it can monitored Clinically , blood gases and Chest X-Ray in 210 patients
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start10 Oct 2021
- Primary completion8 Feb 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Sohag 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Hamed Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140668
- Sponsor's protocol ID
- soh-med-21-11-06
- Status last verified
- Jun 2022
- First submitted
- 14 Nov 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Beheshti MV. A concise history of central venous access. Tech Vasc Interv Radiol. 2011 Dec;14(4):184-5. doi: 10.1053/j.tvir.2011.05.002.
PubMed 22099008Konner K. History of vascular access for haemodialysis. Nephrol Dial Transplant. 2005 Dec;20(12):2629-35. doi: 10.1093/ndt/gfi168. Epub 2005 Oct 4.
PubMed 16204277American Society of Anesthesiologists Task Force on Central Venous Access; Rupp SM, Apfelbaum JL, Blitt C, Caplan RA, Connis RT, Domino KB, Fleisher LA, Grant S, Mark JB, Morray JP, Nickinovich DG, Tung A. Practice guidelines for central venous access: a report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2012 Mar;116(3):539-73. doi: 10.1097/ALN.0b013e31823c9569. No abstract available.
PubMed 22307320Suess EM, Pinsky MR. Hemodynamic Monitoring for the Evaluation and Treatment of Shock: What Is the Current State of the Art? Semin Respir Crit Care Med. 2015 Dec;36(6):890-8. doi: 10.1055/s-0035-1564874. Epub 2015 Nov 23.
PubMed 26595049
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization In Major Elective Surgeries And ICU Patients
- ClinicalTrials.gov ID
- NCT05140668
- Acronym / sponsor ID
- soh-med-21-11-06
- Conditions
- Central Line Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 1 Dec 2021 (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.
A central venous catheter (CVC) is an indwelling device that is peripherally inserted into a larg central vein for a multitude of indications in major elective surgeries and ICU patients and now it's now with notable advance is the adjunct of ultrasound guidance, which has recently become the standard of care for CVCs placed in wanted site to decreases the complications
Detailed description
A central venous catheter (CVC) is an indwelling device that is peripherally inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium.for a multitude of indications including; total parenteral nutrition administration dialysis, plasmapheresis , medication administration, hemodynamic monitoring and to facilitate further complex interventions such as transvenous pacemaker placement inserted with Seldinger's technique. A notable advance is the adjunct of ultrasound guidance, which has recently become the standard of care for CVCs placed in wanted site owing to associated decreases in complications e.g. arterial puncture, haematoma formation, pneumothorax, haemothorax and catheterization failure and an increase in first-pass success.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular central venous catheterization approach group | Active comparator | Device: Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterizationsupraclavicular central venous catheterization group catheter is inserted in supraclavicular fossa (an indentation immediately above the clavicle) with a long-axis in plane approach |
| Infraclavicular central venous catheterization approach group | Active comparator | Device: Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterizationinfraclavicular central venous catheterization group catheter is inserted in infraclavicular fossa (an indentation, immediately below the clavicle, above the third rib and between the deltoid muscle laterally and medioclavicular line medially) with a short-axis out-of-plane approach |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patient refusel Irritable patient Infection at the puncture site medical devices (chemoport, pacemaker,etc.) at the puncture site. right subclavian venous thrombosis haemostatic disorders current anticoagulant medication prescriptions previous history of surgery that might distort the anatomy of the right subclavian vein.
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 |
|---|---|---|
| Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous CatheterizationComparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization | Device | Infraclavicular central venous catheterization approach group, Supraclavicular central venous catheterization approach group |
Primary outcome
to compare between the Supraclavicular and infraclavicular approach in right subclavian vein catheterization as regard accessibility sonar guided and number of punctures which is needed and the time of the procedure
Time frame: 7 months
After successful venous puncture, catheterization was attempted with the Seldinger's technique The guidewire and dilator were inserted to a depth of 10-15 cm and to the depth of venous puncture, respectively. We considered an attempt at catheterization as 'failed' if successful catheterization was not achieved within 3 min or If an anesthetist failed to catheterize the patient successfully within three attempts in 210 patients
1 secondary outcome
to compare complications which result from supraclavicular or approaches for right subclavian venous catheter insertion
Time frame: 7 months
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 30 Jun 2022.
- Background: PubMed 22099008Beheshti MV. A concise history of central venous access. Tech Vasc Interv Radiol. 2011 Dec;14(4):184-5. doi: 10.1053/j.tvir.2011.05.002.
- Background: PubMed 16204277Konner K. History of vascular access for haemodialysis. Nephrol Dial Transplant. 2005 Dec;20(12):2629-35. doi: 10.1093/ndt/gfi168. Epub 2005 Oct 4.
- Background: PubMed 22307320American Society of Anesthesiologists Task Force on Central Venous Access; Rupp SM, Apfelbaum JL, Blitt C, Caplan RA, Connis RT, Domino KB, Fleisher LA, Grant S, Mark JB, Morray JP, Nickinovich DG, Tung A. Practice guidelines for central venous access: a report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2012 Mar;116(3):539-73. doi: 10.1097/ALN.0b013e31823c9569. No abstract available.
- Background: PubMed 26595049Suess EM, Pinsky MR. Hemodynamic Monitoring for the Evaluation and Treatment of Shock: What Is the Current State of the Art? Semin Respir Crit Care Med. 2015 Dec;36(6):890-8. doi: 10.1055/s-0035-1564874. Epub 2015 Nov 23.
- Individual participant dataSharing planned: Yes
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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 Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization in people with Central Line Complication, run by Sohag University at 1 site in Egypt.
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 0 inclusion and 1 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 30 Jun 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 Egypt. 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?
to compare between the Supraclavicular and infraclavicular approach in right subclavian vein catheterization as regard accessibility sonar guided and number of punctures which is needed and the time of the procedure (time frame: 7 months). 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 NCT05140668, which also lists 4 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 30 Jun 2022.