AnesthesiaNCT05771935
Ultrasound Guided Ulnar Versus Radial Artery in Pediatrics Undergoing Major Non Cardiac Surgery
A study testing ultrasound guided radial versus ulnar artery cannulation in people with Anesthesia and Pediatrics, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This study aims to assess the safety and efficacy of ulnar artery cannulation compared to radial artery cannulation in pediatrics undergoing major non cardiac procedures. Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Anesthesia, Pediatrics, Radial Artery
- What is being tested?
- ultrasound guided radial versus ulnar artery cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2023to 1 Oct 2023
- 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 1 month to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All pediatrics ASA I\&II aged 1 month -10 years undergoing major non cardiac surgeries.
Who cannot join
- • Patients undergoing cardiac surgeries.
- Refusal of parents.
- Ischemia defined as (color changes: blanching, duskiness, and or change in temperature of the extremity used for cannulation compared to the contralateral one).
- Previous arterial cannulation within last week.
- Patients requiring inotropic support before the start of procedures.
- Rash or signs of infection or hematoma at the site of cannulation.
- Patients requiring emergency procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Ulnar Versus Radial Artery Cannulation in Pediatrics Undergoing Major Non Cardiac Surgery: Double Blinded Randomized Controlled Study
This study aims to assess the safety and efficacy of ulnar artery cannulation compared to radial artery cannulation in pediatrics undergoing major non cardiac procedures.
Read the detailed description
The study is a double blinded randomized controlled trial that will be conducted at Abu Al Reesh Children's Hospital, Faculty of Medicine, Cairo University after approval of research and ethics committees.
Children will be recruited into the trial during pre-operative assessment. will be randomly assigned to one of two groups Recruited patients will be randomly allocated by a computer-generated sequence of codes using randomization software (https://www. randomizer.org) into one of the two groups; in a 1:1 ratio (Group R) to receive radial artery cannulation and (Group U) to receive ulnar artery cannulation using ultrasound. The randomization sequence will be concealed in sequentially numbered, sealed opaque envelopes. The sealed envelopes will be opened by an anesthesia nurse immediately before induction of anesthesia.
After induction of anesthesia, modified Allen's test will be done by the ultrasound operator as following:
An Esmarch bandage will be used to exsanguinate the selected hand for cannulation according to the operator preference for 30 seconds, then the operator will apply simultaneous pressure to the ulnar and radial arteries of the chosen limb to occlude them. The bandage will then be released. Next, the pressure over the opposed artery selected for cannulation will be released and the time (in seconds) it takes for color to return to the hand will be measured.
Allen test results will be interpreted as follows:
If color returns to the hand within 5 seconds, the result of the Allen test is negative (normal) and the artery can safely be cannulated.
If color does not return to the palm within 5 seconds, the test result is positive (abnormal). The test will be repeated on the other hand and if the test is positive another site will be selected for cannulation, and the patient will be excluded from the study.
The patient's wrist will be extended over a roll to keep the angle of the wrist unchanged to 30- 45 degrees. After hand washing and sterile gloving; skin will be prepared using alcohol-based chlorhexidine antiseptic in both groups.
Assessment of proposed artery for cannulation using ultrasonography will be performed by one of 2 pediatric anesthesiologists blinded to group allocation who have performed more than 50 ultrasound guided arterial cannulation in pediatrics.
Ultrasound examination will be performed using a hockey stick, high frequency (5-10 MHz) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA).
Image depth will be set to 2- 3 cm and gain settings adjusted to enhance views. Both external force and the angle will be manipulated to optimize images.
The radial artery will be identified in the transverse plane and confirmed with color flow doppler, then in the longitudinal plane by rotating the probe 90 degrees clockwise while maintaining the arterial image. This method will be repeated for the ulnar artery. All antro-posterior (AP) and transverse (T) diameters will be made at the inner (intimal) edge of the vessel. AP diameter will be measured on both transverse and longitudinal images. Cross-sectional area (CSA) will be calculated then as following: π [AP × T] /4. Three measurements will be collected, and the average values will be used for analysis.
Arterial cannulation will be performed using the long axis view (in-plane) technique with a 24 or 22-gauge canulae (Euromed For Medical Industries, S.A.E., Cairo, Egypt) according to the operator preference. Cannulation will be considered complete when the arterial waveform is confirmed on the monitor. If cannulation is unsuccessful within the third attempt or within 10 min, the case will be considered a failure at the chosen artery. After the failure, an alternative site will be used for cannulation and the case will be excluded from the study. The overall procedure time of arterial cannulation is defined as the time interval from the first skin puncture by the canula to confirmation of the arterial waveform on the monitor. After the procedure, the diameter of the cannulated artery and the occurrence of hematoma or vasospasm will be evaluated with ultrasound. Data will be collected by another anesthesiologist who is blinded to the group allocation.
- Conditions
- Anesthesia, Pediatrics, Radial Artery, Ulnar Artery
- Being tested
- ultrasound guided radial versus ulnar artery cannulation
- Keywords
- ultrasound, arterial cannulation, radial, ulnar, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided radial versus ulnar artery cannulationProcedure or surgery
Ultrasound examination will be performed using a hockey stick, high frequency (5-10 MHz) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA).
. Arterial cannulation will be performed using the long axis view (in-plane) technique with a 24 or 22-gauge canulae according to the operator preference. Cannulation will be considered complete when the arterial waveform is confirmed on the monitor. If cannulation is unsuccessful within the third attempt or within 10 min, the case will be considered a failure at the chosen artery. After the failure, an alternative site will be used for cannulation and the case will be excluded from the study.
| Study group | Role | What they receive |
|---|---|---|
| (Group R) | Experimental | receive radial artery cannulation using ultrasound Receives: Procedure: ultrasound guided radial versus ulnar artery cannulation |
| (Group U) | Active comparator | receive ulnar artery cannulation using ultrasound Receives: Procedure: ultrasound guided radial versus ulnar artery cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful cannulation at first attempt
(the procedure will be classified as successful when the artery is cannulated, and an arterial waveform is recorded within less than 3 attempts and or 15 minutes from the first puncture).
Measured: 15 minutes
Secondary outcomes (3)
diameters of the arteries before cannulation
Anteroposterior, transverse diameters and cross-sectional area of the arteries before cannulation
Measured: preoperative
diameters of the arteries after cannulation
Anteroposterior, transverse diameters and cross-sectional area of the arteries after cannulation
Measured: 15 minutes from start of cannulation
incidence of vasospasm
more than 25% decrease in the artery diameter after cannulation without intra-arterial hematoma.
Measured: 15 minutes from start of cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start5 Mar 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771935
- Sponsor's protocol ID
- MS-225-2022
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Ulnar Versus Radial Artery Cannulation in Pediatrics Undergoing Major Non Cardiac Surgery: Double Blinded Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05771935
- Acronym / sponsor ID
- MS-225-2022
- Conditions
- Anesthesia, Pediatrics, Radial Artery, Ulnar Artery
- Keywords
- ultrasound, arterial cannulation, radial, ulnar, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 16 Mar 2023 (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.
This study aims to assess the safety and efficacy of ulnar artery cannulation compared to radial artery cannulation in pediatrics undergoing major non cardiac procedures.
Detailed description
The study is a double blinded randomized controlled trial that will be conducted at Abu Al Reesh Children's Hospital, Faculty of Medicine, Cairo University after approval of research and ethics committees.
Children will be recruited into the trial during pre-operative assessment. will be randomly assigned to one of two groups Recruited patients will be randomly allocated by a computer-generated sequence of codes using randomization software (https://www. randomizer.org) into one of the two groups; in a 1:1 ratio (Group R) to receive radial artery cannulation and (Group U) to receive ulnar artery cannulation using ultrasound. The randomization sequence will be concealed in sequentially numbered, sealed opaque envelopes. The sealed envelopes will be opened by an anesthesia nurse immediately before induction of anesthesia.
After induction of anesthesia, modified Allen's test will be done by the ultrasound operator as following:
An Esmarch bandage will be used to exsanguinate the selected hand for cannulation according to the operator preference for 30 seconds, then the operator will apply simultaneous pressure to the ulnar and radial arteries of the chosen limb to occlude them. The bandage will then be released. Next, the pressure over the opposed artery selected for cannulation will be released and the time (in seconds) it takes for color to return to the hand will be measured.
Allen test results will be interpreted as follows:
If color returns to the hand within 5 seconds, the result of the Allen test is negative (normal) and the artery can safely be cannulated.
If color does not return to the palm within 5 seconds, the test result is positive (abnormal). The test will be repeated on the other hand and if the test is positive another site will be selected for cannulation, and the patient will be excluded from the study.
The patient's wrist will be extended over a roll to keep the angle of the wrist unchanged to 30- 45 degrees. After hand washing and sterile gloving; skin will be prepared using alcohol-based chlorhexidine antiseptic in both groups.
Assessment of proposed artery for cannulation using ultrasonography will be performed by one of 2 pediatric anesthesiologists blinded to group allocation who have performed more than 50 ultrasound guided arterial cannulation in pediatrics.
Ultrasound examination will be performed using a hockey stick, high frequency (5-10 MHz) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA).
Image depth will be set to 2- 3 cm and gain settings adjusted to enhance views. Both external force and the angle will be manipulated to optimize images.
The radial artery will be identified in the transverse plane and confirmed with color flow doppler, then in the longitudinal plane by rotating the probe 90 degrees clockwise while maintaining the arterial image. This method will be repeated for the ulnar artery. All antro-posterior (AP) and transverse (T) diameters will be made at the inner (intimal) edge of the vessel. AP diameter will be measured on both transverse and longitudinal images. Cross-sectional area (CSA) will be calculated then as following: π [AP × T] /4. Three measurements will be collected, and the average values will be used for analysis.
Arterial cannulation will be performed using the long axis view (in-plane) technique with a 24 or 22-gauge canulae (Euromed For Medical Industries, S.A.E., Cairo, Egypt) according to the operator preference. Cannulation will be considered complete when the arterial waveform is confirmed on the monitor. If cannulation is unsuccessful within the third attempt or within 10 min, the case will be considered a failure at the chosen artery. After the failure, an alternative site will be used for cannulation and the case will be excluded from the study. The overall procedure time of arterial cannulation is defined as the time interval from the first skin puncture by the canula to confirmation of the arterial waveform on the monitor. After the procedure, the diameter of the cannulated artery and the occurrence of hematoma or vasospasm will be evaluated with ultrasound. Data will be collected by another anesthesiologist who is blinded to the group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Group R) | Experimental | Procedure: ultrasound guided radial versus ulnar artery cannulationreceive radial artery cannulation using ultrasound |
| (Group U) | Active comparator | Procedure: ultrasound guided radial versus ulnar artery cannulationreceive ulnar artery cannulation using ultrasound |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All pediatrics ASA I\&II aged 1 month -10 years undergoing major non cardiac surgeries.
Key exclusion criteria (7 listed)
- • Patients undergoing cardiac 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 |
|---|---|---|
| ultrasound guided radial versus ulnar artery cannulationUltrasound examination will be performed using a hockey stick, high frequency (5-10 MHz) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA). . Arterial cannulation will be performed using the long axis view (in-plane) technique with a 24 or 22-gauge canulae according to the operator preference. Cannulation will be considered complete when the arterial waveform is confirmed on the monitor. If cannulation is unsuccessful within the third attempt or within 10 min, the case will be considered a failure at the chosen artery. After the failure, an alternative site will be used for cannulation and the case will be excluded from the study. | Procedure or surgery | (Group R), (Group U) |
Primary outcome
Rate of successful cannulation at first attempt
Time frame: 15 minutes
(the procedure will be classified as successful when the artery is cannulated, and an arterial waveform is recorded within less than 3 attempts and or 15 minutes from the first puncture).
3 secondary outcomes
diameters of the arteries before cannulation
Time frame: preoperative
diameters of the arteries after cannulation
Time frame: 15 minutes from start of cannulation
incidence of vasospasm
Time frame: 15 minutes from start of cannulation
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 5 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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 ultrasound guided radial versus ulnar artery cannulation in people with Anesthesia and Pediatrics, run by Kasr El Aini Hospital 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 7 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 5 Mar 2024. 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?
Rate of successful cannulation at first attempt (time frame: 15 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 5 Mar 2024.