Peripheral PerfusionNCT03845361
Radial Artery Cannulation and Perfusion Index
A study testing Radial artery cannulation in people with Peripheral Perfusion, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to investigate if radial artery cannulation of the dominant hand affects its peripheral perfusion during cardiac surgery using cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Peripheral Perfusion
- 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
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Feb 2019to 21 Feb 2021
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective cardiac surgery using cardiopulmonary bypass
Who cannot join
- Peripheral vascular diseases
- previous upper limb surgeries
- planned radial artery harvesting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Radial Artery Cannulation Affect the Perfusion of the Dominant Hand in Patients Undergoing Open Cardiac Surgery? Data Derived From the Peripheral Perfusion Index.
This study aims to investigate if radial artery cannulation of the dominant hand affects its peripheral perfusion during cardiac surgery using cardiopulmonary bypass.
Read the detailed description
Invasive blood pressure monitoring is mandatory in cardiac surgeries. Radial artery cannulation is the most common technique used for monitoring of invasive blood pressure and for arterial blood gas analysis.
Perfusion index derived from pulse oximetry is a new method for monitoring of peripheral perfusion.
this study aims to investigate if radial artery cannulation affects the intra-operative peripheral perfusion in the dominant cannulated hand
- Conditions
- Peripheral Perfusion
- Being tested
- Radial artery cannulation
- Keywords
- Perfusion index, Cardiac Surgery, 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 |
|---|---|---|
| C. hand | Experimental | Radial artery cannulation Receives: Procedure: Radial artery cannulation |
| N.C. hand | No intervention | No cannulation of the radial artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The perfusion index
Measured: Intraoperative
The peripheral temperature
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start21 Feb 2019
- Primary completion21 Jan 2021
- Study completion21 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral PerfusionStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mostafa Esmaeil Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845361
- Sponsor's protocol ID
- Radial perfusion index
- Status last verified
- Oct 2022
- First submitted
- 25 Dec 2018
- Last updated
- 19 Oct 2022
- Results posted
- 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 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Radial Artery Cannulation Affect the Perfusion of the Dominant Hand in Patients Undergoing Open Cardiac Surgery? Data Derived From the Peripheral Perfusion Index.
- ClinicalTrials.gov ID
- NCT03845361
- Acronym / sponsor ID
- Radial perfusion index
- Conditions
- Peripheral Perfusion
- Keywords
- Perfusion index, Cardiac Surgery, Radial artery cannulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Feb 2021 (actual)
- First posted
- 19 Feb 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.
This study aims to investigate if radial artery cannulation of the dominant hand affects its peripheral perfusion during cardiac surgery using cardiopulmonary bypass.
Detailed description
Invasive blood pressure monitoring is mandatory in cardiac surgeries. Radial artery cannulation is the most common technique used for monitoring of invasive blood pressure and for arterial blood gas analysis.
Perfusion index derived from pulse oximetry is a new method for monitoring of peripheral perfusion.
this study aims to investigate if radial artery cannulation affects the intra-operative peripheral perfusion in the dominant cannulated hand
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C. hand | Experimental | Procedure: Radial artery cannulationRadial artery cannulation |
| N.C. hand | No intervention | –No cannulation of the radial artery |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective cardiac surgery using cardiopulmonary bypass
Key exclusion criteria (3 listed)
- Peripheral vascular diseases
- previous upper limb surgeries
- planned radial artery harvesting
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 | C. hand |
Primary outcome
The perfusion index
Time frame: Intraoperative
The peripheral temperature
Time frame: Intraoperative
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 19 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Sepsis
RecruitingObservational study
Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit
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Not yet recruitingObservational study
Core-to-Big-Toe Temperature Gradient as a Marker of Peripheral Perfusion in Adult Patients With Septic Shock
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Not yet recruitingPhase 4
Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery
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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 Radial artery cannulation in people with Peripheral Perfusion, run by Assiut 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 3 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 19 Oct 2022. 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?
The perfusion index (time frame: Intraoperative). The study lists 2 primary outcomes in all. 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 19 Oct 2022.