Accidental Puncture of Artery During Catheter InsertionNCT02687126

Ultrasound Guided Technique for Internal Jugular Central Venous Catheterization in Pediatric Cardiac Surgical Patients

A study testing Central Venous Catheterization in people with Accidental Puncture of Artery During Catheter Insertion, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the success rate using ultrasound as guidance during central venous cannulation in pediatric cardiac surgical patients. Read more about this study

Who is it for?: Ages 1 day to 15 years
Conditions the study is for: Accidental Puncture of Artery During Catheter Insertion
What is being tested?: Central Venous Catheterization
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteNepal
Study dates: Feb 2016to Nov 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 day to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients requiring central venous catheterization for elective cardiac surgery.
Age below 15 years.

Who cannot join

Patient's guardian's refusal
Bleeding disorders
Clotting abnormalities (platelets count < 75,000/cumm, INR > 2)
Local site of infection
Underlying pneumothorax, pleural effusion or preoperative insertion of chest tube

Trial locations and contacts

1 site in 1 country.

Nepal1 site

Shahid Gangalal NationalHeart Centre
Kathmandu, Bagmati, 44606

Other trials in Nepal

About this study

The purpose of the study is to evaluate the success rate using ultrasound as guidance during central venous cannulation in pediatric cardiac surgical patients.

Read the detailed description

Central venous access may be essential in pediatric patients for fluid and a blood product administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic monitoring. Obtaining central venous access in pediatric patients can be challenging, failure rates in pediatric patients range from 5% to 19% with reported complication rates from 2.5% to 22%. The landmark technique has been standard approach for many years. In comparison with landmark method, in pediatric patients, the use of ultrasound is associated with an increased success rate decreased operative time, reduced number of cannulation attempts , and a decreased number of carotid artery punctures. This study is designed to evaluate the success rate, complications, time taken for successful cannulation and their correlation with cross sectional area of the vein.

Conditions: Accidental Puncture of Artery During Catheter Insertion
Being tested: Central Venous Catheterization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Central Venous CatheterizationDevice
Ultrasound guided internal jugular venous catheterization

Study groups in NCT02687126
Study group	Role	What they receive
Pediatric Cardiac Surgical Patients	Other	Central Venous Catheterization Receives: Device: Central Venous Catheterization

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Attempts for Successful Central Venous Cannulation
An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur
Measured: up to 24 hours after intervention

Secondary outcomes (2)

Time to Successful Cannulation
Time from skin prick to blood aspiration via the catheter immediately following the guide-wire removal
Measured: up to 1 hour after intervention
Number of Patients With Complications
Arterial puncture, Hemothorax, Pneumothorax, Local site hematoma
Measured: up to 24 hours after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Nov 2016

First posted22 Feb 2016 (estimated)
Study startFeb 2016
Primary completionOct 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Accidental Puncture of Artery During Catheter InsertionStudies 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02687126
Sponsor's protocol ID: SGNHC
Status last verified: Mar 2017
First submitted: 15 Jan 2016
Last updated: 25 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Froehlich CD, Rigby MR, Rosenberg ES, Li R, Roerig PL, Easley KA, Stockwell JA. Ultrasound-guided central venous catheter placement decreases complications and decreases placement attempts compared with the landmark technique in patients in a pediatric intensive care unit. Crit Care Med. 2009 Mar;37(3):1090-6. doi: 10.1097/CCM.0b013e31819b570e.
PubMed 19237922
Wigmore TJ, Smythe JF, Hacking MB, Raobaikady R, MacCallum NS. Effect of the implementation of NICE guidelines for ultrasound guidance on the complication rates associated with central venous catheter placement in patients presenting for routine surgery in a tertiary referral centre. Br J Anaesth. 2007 Nov;99(5):662-5. doi: 10.1093/bja/aem262. Epub 2007 Sep 14.
PubMed 17872936

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound Guided Technique for Internal Jugular Central Venous Catheterization in Pediatric Cardiac Surgical Patients
ClinicalTrials.gov ID: NCT02687126
Acronym / sponsor ID: SGNHC
Conditions: Accidental Puncture of Artery During Catheter Insertion
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Shahid Gangalal National Heart CentreUniversity, hospital or other
Study start: Feb 2016
Primary completion: Oct 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 22 Feb 2016 (estimated)
Results: Posted 25 Apr 2017

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 success rate using ultrasound as guidance during central venous cannulation in pediatric cardiac surgical patients.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pediatric Cardiac Surgical Patients	Other	Device: Central Venous CatheterizationCentral Venous Catheterization

Who may qualify

Ages: 1 day to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Patients requiring central venous catheterization for elective cardiac surgery.
Age below 15 years.

Key exclusion criteria (5 listed)

Patient's guardian's refusal
Bleeding disorders
Clotting abnormalities (platelets count < 75,000/cumm, INR > 2)
Local site of infection
Underlying pneumothorax, pleural effusion or preoperative insertion of chest tube

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
Central Venous CatheterizationUltrasound guided internal jugular venous catheterization	Device	Pediatric Cardiac Surgical Patients

Primary outcome

Number of Attempts for Successful Central Venous Cannulation
Time frame: up to 24 hours after intervention
An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur

2 secondary outcomes

Time to Successful Cannulation
Time frame: up to 1 hour after intervention
Number of Patients With Complications
Time frame: up to 24 hours after intervention

Results and safety

Results posted to the registry on 25 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ultrasound Guided Central Venous Catheterization	106	106

Primary outcome: Number of Attempts for Successful Central Venous Cannulation

Time frame: up to 24 hours after intervention. Mean (Standard Deviation). Unit: Attempts

Measure	Number of Attempts n = 106
Value	1.29 (0.59)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Number of Complications	11 of 106 (10.4%)	11 of 106 (10.4%)	0 of 106

Limitations and caveats (from the sponsor): Disease conditions of the patients may affect the size of the internal jugular vein. We did not evaluate the outcome variables in different disease conditions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19237922Froehlich CD, Rigby MR, Rosenberg ES, Li R, Roerig PL, Easley KA, Stockwell JA. Ultrasound-guided central venous catheter placement decreases complications and decreases placement attempts compared with the landmark technique in patients in a pediatric intensive care unit. Crit Care Med. 2009 Mar;37(3):1090-6. doi: 10.1097/CCM.0b013e31819b570e.
Results publication: PubMed 17872936Wigmore TJ, Smythe JF, Hacking MB, Raobaikady R, MacCallum NS. Effect of the implementation of NICE guidelines for ultrasound guidance on the complication rates associated with central venous catheter placement in patients presenting for routine surgery in a tertiary referral centre. Br J Anaesth. 2007 Nov;99(5):662-5. doi: 10.1093/bja/aem262. Epub 2007 Sep 14.
Individual participant dataSharing planned: Undecided

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.

Santosh S Parajuli, MD principal investigator

Shahid Gangalal National Heart Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Central Venous Catheterization in people with Accidental Puncture of Artery During Catheter Insertion, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.

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 5 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 25 Apr 2017. 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 Nepal. 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?

Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Attempts for Successful Central Venous Cannulation (time frame: up to 24 hours after intervention). 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 NCT02687126, which also lists 2 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 25 Apr 2017.