Perfusion; ComplicationsNCT06077396
Does Radial Artery Cannulation Affect the Perfusion Index(PI) of the Hand in Liver Transplant Operations?
A study testing radial artery cannulation in people with Perfusion; Complications and Arterial Catheterization, Peripheral, run by Inonu University.
Trial summary
radial artery cannulation is performed by an experienced person, non-invasive blood pressure measurement will be made at 3 stages of the operation (dissection, anhepatic, neohepatic) and the effects of radial artery cannulation on the perfusion index will be evaluated by recording the correlation between radial artery… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Perfusion; Complications, Arterial Catheterization, Peripheral
- What is being tested?
- radial artery cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Jul 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing liver transplantation Patients who will undergo intraarterial cannulation
Who cannot join
- Peripheral vascular diseases Prior upper extremity surgery Radial artery injury
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does Radial Artery Cannulation Affect the Perfusion Index of the Hand in Liver Transplant?
radial artery cannulation is performed by an experienced person, non-invasive blood pressure measurement will be made at 3 stages of the operation (dissection, anhepatic, neohepatic) and the effects of radial artery cannulation on the perfusion index will be evaluated by recording the correlation between radial artery and invasive measurements and the perfusion indexes of both hands simultaneously with Masimo.
Read the detailed description
Arterial lines placement is for real-time monitoring of blood pressures and arterial blood sampling in critically ill patients or those undergoing complex procedures and surgeries.
Routine monitoring will be performed after the patients are taken to the operating room. Before bilateral radial artery cannulation, allen test will be performed and entrance perfusion indexes will be checked. After radial artery cannulation is performed by an experienced person, non-invasive blood pressure measurement will be made at 3 stages of the operation (dissection, anhepatic, neohepatic) and the effects of radial artery cannulation on the perfusion index will be evaluated by recording the correlation between radial artery and invasive measurements and the perfusion indexes of both hands simultaneously with Masimo.
- Being tested
- radial artery cannulation
- Keywords
- perfusion index, liver transplantation, radial artery cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radial artery cannulationProcedure or surgery
radial artery cannulation
| Study group | Role | What they receive |
|---|---|---|
| To evaluate the effect of radial artery cannulation on hand perfusion | Other | To evaluate the effect of radial artery cannulation on hand perfusion Receives: Procedure: radial artery cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the perfusion index of the hand in which artery cannulation was performed with Masimo.There is no result range
Arterial cannulation is mandatory for hemodynamic data monitoring in liver transplantation and is performed routinely. To evaluate the perfusion of the hand of the patients after cannulation
Measured: Intraoperative (patients during surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perfusion; ComplicationsStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who underwent radial artery cannulation in liver transplantation
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DUYGU DEMİROZ, Inonu University
- Investigators
- duygu demiröz, Principal investigator, INONU UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077396
- Sponsor's protocol ID
- LIVER TRANSP
- Status last verified
- Feb 2024
- First submitted
- 25 Aug 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brzezinski M, Luisetti T, London MJ. Radial artery cannulation: a comprehensive review of recent anatomic and physiologic investigations. Anesth Analg. 2009 Dec;109(6):1763-81. doi: 10.1213/ANE.0b013e3181bbd416.
PubMed 19923502Numaguchi A, Adachi YU, Aoki Y, Ishii Y, Suzuki K, Obata Y, Sato S, Nishiwaki K, Matsuda N. Radial artery cannulation decreases the distal arterial blood flow measured by power Doppler ultrasound. J Clin Monit Comput. 2015 Oct;29(5):653-7. doi: 10.1007/s10877-014-9648-5. Epub 2014 Dec 16.
PubMed 25516161
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Radial Artery Cannulation Affect the Perfusion Index of the Hand in Liver Transplant?
- ClinicalTrials.gov ID
- NCT06077396
- Acronym / sponsor ID
- LIVER TRANSP
- Keywords
- perfusion index, liver transplantation, radial artery cannulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 11 Oct 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.
radial artery cannulation is performed by an experienced person, non-invasive blood pressure measurement will be made at 3 stages of the operation (dissection, anhepatic, neohepatic) and the effects of radial artery cannulation on the perfusion index will be evaluated by recording the correlation between radial artery and invasive measurements and the perfusion indexes of both hands simultaneously with Masimo.
Detailed description
Arterial lines placement is for real-time monitoring of blood pressures and arterial blood sampling in critically ill patients or those undergoing complex procedures and surgeries.
Routine monitoring will be performed after the patients are taken to the operating room. Before bilateral radial artery cannulation, allen test will be performed and entrance perfusion indexes will be checked. After radial artery cannulation is performed by an experienced person, non-invasive blood pressure measurement will be made at 3 stages of the operation (dissection, anhepatic, neohepatic) and the effects of radial artery cannulation on the perfusion index will be evaluated by recording the correlation between radial artery and invasive measurements and the perfusion indexes of both hands simultaneously with Masimo.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who underwent radial artery cannulation in liver transplantation
| Arm | Type | Receives |
|---|---|---|
| To evaluate the effect of radial artery cannulation on hand perfusion | Other | Procedure: radial artery cannulationTo evaluate the effect of radial artery cannulation on hand perfusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing liver transplantation Patients who will undergo intraarterial cannulation
Key exclusion criteria (1 listed)
- Peripheral vascular diseases Prior upper extremity surgery Radial artery injury
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 |
|---|---|---|
| radial artery cannulationradial artery cannulation | Procedure or surgery | To evaluate the effect of radial artery cannulation on hand perfusion |
Primary outcome
To evaluate the perfusion index of the hand in which artery cannulation was performed with Masimo.There is no result range
Time frame: Intraoperative (patients during surgery)
Arterial cannulation is mandatory for hemodynamic data monitoring in liver transplantation and is performed routinely. To evaluate the perfusion of the hand of the patients after cannulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 19923502Brzezinski M, Luisetti T, London MJ. Radial artery cannulation: a comprehensive review of recent anatomic and physiologic investigations. Anesth Analg. 2009 Dec;109(6):1763-81. doi: 10.1213/ANE.0b013e3181bbd416.
- Background: PubMed 25516161Numaguchi A, Adachi YU, Aoki Y, Ishii Y, Suzuki K, Obata Y, Sato S, Nishiwaki K, Matsuda N. Radial artery cannulation decreases the distal arterial blood flow measured by power Doppler ultrasound. J Clin Monit Comput. 2015 Oct;29(5):653-7. doi: 10.1007/s10877-014-9648-5. Epub 2014 Dec 16.
- 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.
duygu demiröz principal investigator
INONU UNİVERSİTY
Questions about this trial
What is this clinical trial studying?
A study testing radial artery cannulation in people with Perfusion; Complications and Arterial Catheterization, Peripheral, run by Inonu University.
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 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: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact duygu demiroz (905319504421, drduygudemiroz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the perfusion index of the hand in which artery cannulation was performed with Masimo.There is no result range (time frame: Intraoperative (patients during surgery)). 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 NCT06077396, 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 6 Feb 2024.