Radial Artery CanulationPhase 4NCT04002544
Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children
A Phase 4 study testing NTG patch and gauze cover in people with Radial Artery Canulation, run by Cairo University at 1 site in Egypt.
Trial summary
Local nitroglycerin (NTG) was successfully used as a vasodilator to facilitate cannulation of the radial artery. NTG was used in adults by topical application as well as subcutaneous infiltration. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Radial Artery Canulation
- What is being tested?
- NTG patch and gauze cover
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2019to 30 Nov 2019
- Phase
- Phase 4
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged between 2 and 5 years scheduled for cardiac surgery
Who cannot join
- Systolic blood pressure less than 90 mmHg,
- previous radial artery puncture
- abnormal Allen's test
- hypercoagulable states
- coagulopathy
- previous vascular complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children: a Randomized Controlled Study
Local nitroglycerin (NTG) was successfully used as a vasodilator to facilitate cannulation of the radial artery. NTG was used in adults by topical application as well as subcutaneous infiltration. Subcutaneous infiltration of NTG resulted in significant vasodilatation, improved palpability of the radial artery, reduced the number of punctures and the time needed for cannulation in adults. Topical NTG was reported to increase radial artery diameter in healthy volunteers without reduction in arterial blood pressure. In pediatric population, there no sufficient evidence for the effectiveness of NTG in improving radial artery cannulation. In a case report on two neonates, topical nitroderm ointment successfully reversed tissue ischemia secondary to radial artery cannulation The aim of this work is to evaluate the use of topical NTG (patch) for increasing the diameter of radial artery, improving the cannulation success, and decreasing catheter-related ischemic complications.
Read the detailed description
A written informed consent will be obtained from patient's parents or guardians. Randomization will be obtained using computer-generated sequence. Concealment will be obtained using opaque envelopes.
On arrival to the preparing room, patients will be randomized into one of the two groups:
- NTG group or, Control group
Ultrasound examination:
The diameter of radial artery will be measured using a linear, high frequency probe (12 mHz) of Simens machine. Measurement will be obtained in the short axis plane at the point with maximal pulsation. The point will be marked to guide the post-intervention examination. The operator will be an experienced single operator blinded to the study group. Measurements will be obtained in both limbs at baseline (before application of NTG patch application,30 minutes,60minutes after NTG application After induction of anesthesia, radial artery will be punctured by 22-g catheter by an experienced anesthetist
- Conditions
- Radial Artery Canulation
- Being tested
- NTG patch, gauze cover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTG patchDrug
A half-NTG patch (dose calculated at 5-12.5 mcg/kg/hr) will be applied to patients at the site of radial pulsation one hour before induction of anesthesia. The NTG patch will be applied to the right upper in half of the patients and will be applied to the left upper limb in the other half
gauze coverOther
A gauze will be applied near the radial artery pulsation to ensure blinding
| Study group | Role | What they receive |
|---|---|---|
| NTG group | Active comparator | In this group, nitroglycerin patch will be applied near the radial artery pulsation covered with a gauze. Receives: Drug: NTG patch; Other: gauze cover |
| Control group | Placebo comparator | In this group, no patch as applied to the patient. However, a gauze will be applied to confirm blinding Receives: Other: gauze cover |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in The diameter of radial artery
mm
Measured: 1 minutes before intervention then 30 and 60-minutes after the intervention
Secondary outcomes (6)
palpability of radial pulse after NTG patch application
Grade 0: palpability did not change after NTG, grade 1: palpability improved after NTG, grade 2: palpability became bounding after NTG
Measured: 1 minutes before intervention then 30 and 60-minutes after the intervention
Number of arterial punctures
number
Measured: 30 minutes
successful cannulation confirmed
incidence
Measured: 30 minutes
successful first-puncture cannulation
incidence
Measured: 30 minutes
postoperative ischemic complications
incidence
Measured: 24 hours post intervention
systolic blood pressure
mmHg
Measured: 1 minute before the intervention, every 5 minutes for 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start15 Sep 2019
- Primary completion15 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery CanulationStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ashraf Rady, Professor, Study director, Head of department of anesthesia, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002544
- Sponsor's protocol ID
- S72019
- Status last verified
- Dec 2019
- First submitted
- 26 Jun 2019
- Last updated
- 11 Dec 2019
- 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 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04002544
- Acronym / sponsor ID
- S72019
- Conditions
- Radial Artery Canulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 28 Jun 2019 (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.
Local nitroglycerin (NTG) was successfully used as a vasodilator to facilitate cannulation of the radial artery. NTG was used in adults by topical application as well as subcutaneous infiltration. Subcutaneous infiltration of NTG resulted in significant vasodilatation, improved palpability of the radial artery, reduced the number of punctures and the time needed for cannulation in adults. Topical NTG was reported to increase radial artery diameter in healthy volunteers without reduction in arterial blood pressure. In pediatric population, there no sufficient evidence for the effectiveness of NTG in improving radial artery cannulation. In a case report on two neonates, topical nitroderm ointment successfully reversed tissue ischemia secondary to radial artery cannulation The aim of this work is to evaluate the use of topical NTG (patch) for increasing the diameter of radial artery, improving the cannulation success, and decreasing catheter-related ischemic complications.
Detailed description
A written informed consent will be obtained from patient's parents or guardians. Randomization will be obtained using computer-generated sequence. Concealment will be obtained using opaque envelopes.
On arrival to the preparing room, patients will be randomized into one of the two groups:
- NTG group or, Control group
Ultrasound examination:
The diameter of radial artery will be measured using a linear, high frequency probe (12 mHz) of Simens machine. Measurement will be obtained in the short axis plane at the point with maximal pulsation. The point will be marked to guide the post-intervention examination. The operator will be an experienced single operator blinded to the study group. Measurements will be obtained in both limbs at baseline (before application of NTG patch application,30 minutes,60minutes after NTG application After induction of anesthesia, radial artery will be punctured by 22-g catheter by an experienced anesthetist
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTG group | Active comparator | Drug: NTG patch, Other: gauze coverIn this group, nitroglycerin patch will be applied near the radial artery pulsation covered with a gauze. |
| Control group | Placebo comparator | Other: gauze coverIn this group, no patch as applied to the patient. However, a gauze will be applied to confirm blinding |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children aged between 2 and 5 years scheduled for cardiac surgery
Key exclusion criteria (6 listed)
- Systolic blood pressure less than 90 mmHg,
- previous radial artery puncture
- abnormal Allen's test
- hypercoagulable states
- coagulopathy
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 |
|---|---|---|
| NTG patchA half-NTG patch (dose calculated at 5-12.5 mcg/kg/hr) will be applied to patients at the site of radial pulsation one hour before induction of anesthesia. The NTG patch will be applied to the right upper in half of the patients and will be applied to the left upper limb in the other half | Drug | NTG group |
| gauze coverA gauze will be applied near the radial artery pulsation to ensure blinding | Other | Control group, NTG group |
Primary outcome
change in The diameter of radial artery
Time frame: 1 minutes before intervention then 30 and 60-minutes after the intervention
mm
6 secondary outcomes
palpability of radial pulse after NTG patch application
Time frame: 1 minutes before intervention then 30 and 60-minutes after the intervention
Number of arterial punctures
Time frame: 30 minutes
successful cannulation confirmed
Time frame: 30 minutes
successful first-puncture cannulation
Time frame: 30 minutes
postoperative ischemic complications
Time frame: 24 hours post intervention
systolic blood pressure
Time frame: 1 minute before the intervention, every 5 minutes for 1 hour
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 11 Dec 2019.
- Individual participant dataSharing planned: No
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.
Ashraf Rady, Professor study director
Head of department of anesthesia, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NTG patch and gauze cover in people with Radial Artery Canulation, run by Cairo 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 1 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: finished, as of the sponsor's last update on 11 Dec 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in The diameter of radial artery (time frame: 1 minutes before intervention then 30 and 60-minutes after the intervention). 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 11 Dec 2019.