Perioperative/Postoperative ComplicationsArCanUSNCT05249036
Arterial Cannulation With Ultrasound
A study testing Ultrasound guided arterial cannulation and Palpation guided arterial cannulation in people with Perioperative/Postoperative Complications, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
A drop in blood pressure during anaesthesia for a surgical procedure has been associated with worse patient outcomes, including complications such as damage to the heart, brain and kidneys. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perioperative/Postoperative Complications
- What is being tested?
- Ultrasound guided arterial cannulation and Palpation guided arterial cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Dec 2021to 30 Nov 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo major elective or urgent (not requiring intervention in <24 hours) non-cardiac surgery under general anaesthesia and/or neuraxial anaesthesia, expected to take >120 minutes from induction of anaesthesia
- Requiring overnight hospital stay.
Who cannot join
- Anatomical deformity
- Unable to consent
- Cannulation attempt within 24 hours
- Overlying infection
Trial locations and contacts
1 site in 1 country.
About this study
A drop in blood pressure during anaesthesia for a surgical procedure has been associated with worse patient outcomes, including complications such as damage to the heart, brain and kidneys. Continuous blood pressure monitoring prior to the start of anaesthesia alerts the anaesthetist to drops in blood pressure and allows this to be treated promptly. This may help to avoid the complications described above.
Continuous blood pressure monitoring is carried out by inserting a small plastic tube (cannula) into an artery. In this study, the investigators propose inserting a cannula into the radial artery in the wrist before a patient is anaesthetised for surgery. The usual technique for insertion of this cannula is for the anaesthetist to identify the site of the radial artery by feeling for an arterial pulse with the fingertips (palpation). An alternative technique for identification is to use ultrasound. Ultrasound creates a two-dimensional image of the area under the skin on a screen, enabling the operator to visualise the artery being targeted. This may reduce the number of cannulation attempts required, reducing patient discomfort.
Read the detailed description
The investigators will test whether ultrasound guidance improves the success rate of radial artery cannulation, compared to palpation alone, in a randomised controlled trial in an NHS hospital. Patients will be over 45 years old, undergoing general or neuraxial anaesthesia for non-cardiac surgery lasting 120 minutes or more. Patients will be randomly assigned to a palpation or ultrasound-guided technique for arterial cannulation. Patients will receive numbing local anaesthetic cream to the area beforehand. A needle is used to introduce the cannula into the artery. There will be a maximum of one attempt allowed. In addition to measuring success rate, we will also compare whether the successfully sited cannula provides an adequate arterial waveform, requires resiting at any point during the surgery and any complications which arise directly related to arterial catheterisation. Patients will receive standard anaesthetic and surgical care in all other respects.
- Being tested
- Ultrasound guided arterial cannulation, Palpation guided arterial cannulation
- Keywords
- Arterial cannulation, Ultrasound
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided arterial cannulationProcedure or surgery
Arterial cannulation will be attempted at the site of the radial artery of the non-dominant hand, using real-time ultrasound guidance
Palpation guided arterial cannulationProcedure or surgery
Arterial cannulation will be attempted at the site of the radial artery of the non-dominant hand, using palpation technique (standard-of-care)
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided arterial cannulation | Experimental | Anaesthetist will use real-time ultrasound guidance to guide arterial cannulation Receives: Procedure: Ultrasound guided arterial cannulation |
| Palpation guided arterial cannulation | Active comparator | Anaesthetist will use palpation (standard-of-care) technique to guide arterial cannulation Receives: Procedure: Palpation guided arterial cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate at first attempt to cannulate the radial artery
Success is defined as radial artery cannulation resulting in a transduced arterial waveform. First attempt is defined as one needle puncture through the skin.
Measured: 10 minutes
Secondary outcomes (2)
Characteristics of arterial waveform
Assessment for presence of: (1) Dicrotic notch; (2) >1 oscillation after fast flush; (3) <3 oscillations after fast flush
Measured: Within 15 mins of catheterisation.
Complications
Recannulation required before/after surgery, infection, hematoma, thrombus.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start25 Dec 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Why it stopped: Primary event rate far higher than estimated for sample size calculation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- The London Clinic
- Responsible party
- Sponsor
- Investigators
- Gareth L Ackland, PhD FRCA, Principal investigator, Translational Medicine & Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249036
- Sponsor's protocol ID
- 301584
- Acronym
- ArCanUS
- Status last verified
- Aug 2024
- First submitted
- 26 Jan 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lan-Pak-Kee V, Ackland GL, Egan TC, Abbott TE, Elsheikh F; Arterial Cannulation with Ultrasound Investigators. Arterial cannulation with ultrasound: clinical trial protocol for a randomised controlled trial comparing handheld ultrasound versus palpation technique for radial artery cannulation. BJA Open. 2022 Dec;4:None. doi: 10.1016/j.bjao.2022.100111.
PubMed 36561483
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Cannulation With Ultrasound
- ClinicalTrials.gov ID
- NCT05249036
- Acronym / sponsor ID
- ArCanUS / 301584
- Keywords
- Arterial cannulation, Ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary event rate far higher than estimated for sample size calculation.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- The London Clinic
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 21 Feb 2022 (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 drop in blood pressure during anaesthesia for a surgical procedure has been associated with worse patient outcomes, including complications such as damage to the heart, brain and kidneys. Continuous blood pressure monitoring prior to the start of anaesthesia alerts the anaesthetist to drops in blood pressure and allows this to be treated promptly. This may help to avoid the complications described above.
Continuous blood pressure monitoring is carried out by inserting a small plastic tube (cannula) into an artery. In this study, the investigators propose inserting a cannula into the radial artery in the wrist before a patient is anaesthetised for surgery. The usual technique for insertion of this cannula is for the anaesthetist to identify the site of the radial artery by feeling for an arterial pulse with the fingertips (palpation). An alternative technique for identification is to use ultrasound. Ultrasound creates a two-dimensional image of the area under the skin on a screen, enabling the operator to visualise the artery being targeted. This may reduce the number of cannulation attempts required, reducing patient discomfort.
Detailed description
The investigators will test whether ultrasound guidance improves the success rate of radial artery cannulation, compared to palpation alone, in a randomised controlled trial in an NHS hospital. Patients will be over 45 years old, undergoing general or neuraxial anaesthesia for non-cardiac surgery lasting 120 minutes or more. Patients will be randomly assigned to a palpation or ultrasound-guided technique for arterial cannulation. Patients will receive numbing local anaesthetic cream to the area beforehand. A needle is used to introduce the cannula into the artery. There will be a maximum of one attempt allowed. In addition to measuring success rate, we will also compare whether the successfully sited cannula provides an adequate arterial waveform, requires resiting at any point during the surgery and any complications which arise directly related to arterial catheterisation. Patients will receive standard anaesthetic and surgical care in all other respects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided arterial cannulation | Experimental | Procedure: Ultrasound guided arterial cannulationAnaesthetist will use real-time ultrasound guidance to guide arterial cannulation |
| Palpation guided arterial cannulation | Active comparator | Procedure: Palpation guided arterial cannulationAnaesthetist will use palpation (standard-of-care) technique to guide arterial cannulation |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo major elective or urgent (not requiring intervention in <24 hours) non-cardiac surgery under general anaesthesia and/or neuraxial anaesthesia, expected to take >120 minutes from induction of anaesthesia
- Requiring overnight hospital stay.
Key exclusion criteria (4 listed)
- Anatomical deformity
- Unable to consent
- Cannulation attempt within 24 hours
- Overlying infection
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 arterial cannulationArterial cannulation will be attempted at the site of the radial artery of the non-dominant hand, using real-time ultrasound guidance | Procedure or surgery | Ultrasound guided arterial cannulation |
| Palpation guided arterial cannulationArterial cannulation will be attempted at the site of the radial artery of the non-dominant hand, using palpation technique (standard-of-care) | Procedure or surgery | Palpation guided arterial cannulation |
Primary outcome
Success rate at first attempt to cannulate the radial artery
Time frame: 10 minutes
Success is defined as radial artery cannulation resulting in a transduced arterial waveform. First attempt is defined as one needle puncture through the skin.
2 secondary outcomes
Characteristics of arterial waveform
Time frame: Within 15 mins of catheterisation.
Complications
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Primary event rate far higher than estimated for sample size calculation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 36561483Lan-Pak-Kee V, Ackland GL, Egan TC, Abbott TE, Elsheikh F; Arterial Cannulation with Ultrasound Investigators. Arterial cannulation with ultrasound: clinical trial protocol for a randomised controlled trial comparing handheld ultrasound versus palpation technique for radial artery cannulation. BJA Open. 2022 Dec;4:None. doi: 10.1016/j.bjao.2022.100111.
- 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.
Gareth L Ackland, PhD FRCA principal investigator
Translational Medicine & Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London
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 arterial cannulation and Palpation guided arterial cannulation in people with Perioperative/Postoperative Complications, run by Queen Mary University of London at 1 site in United Kingdom.
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 4 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: stopped early, as of the sponsor's last update on 15 Aug 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 United Kingdom. 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 was stopped early (reason given: Primary event rate far higher than estimated for sample size calculation.). Results are not available in the source record.
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?
Success rate at first attempt to cannulate the radial artery (time frame: 10 minutes). 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 NCT05249036, which also lists 1 linked publication.
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 15 Aug 2024.