Ischemic Heart DiseaseNCT05349773
The Pneumatic Tourniquet Technique for Endoscopic Radial Artery Harvest; Does it Affect Patient Hemodynamics?
An observational study of Ischemic Heart Disease and Coronary Artery Bypass Graft, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to investigate the effect of the pneumatic tourniquet technique on the patients' hemodynamics; heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Ischemic Heart Disease, Coronary Artery Bypass Graft
- What is being tested?
- Pneumatic tourniquet, endoscopic left radial artery harvesting
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 19 May 2022to 1 Aug 2022
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients who are listed for CABG surgery with the use of ERAH technique at cardiothoracic and vascular surgery center (Mansoura University Hospitals, Mansoura University) are eligible for this study.
Who may be able to join
- Listed for CABG surgery with the use of ERAH technique.
Who cannot join
- Emergency CABG surgery.
- CABG plus any other cardiac surgery.
- The use of inopressor drugs before ERAH
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the effect of the pneumatic tourniquet technique on the patients' hemodynamics; heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Read the detailed description
Coronary artery bypass graft surgery (CABG) is the most common cardiac surgical procedure. Radial artery of the non-dominant hand with better ulnar collaterals is preferred over the saphenous vein because of long term patency of the radial artery. Radial artery is the preferred second or third arterial conduits for vessels with sub occlusive stenosis.
There are two techniques of radial artery harvesting; open and endoscopic techniques. Endoscopic radial artery harvesting (ERAH) is increasing and it is possible but the evidence regarding its safety is scarce. ERAH is cosmetically better than the open technique.
ERAH technique is performed after applying a tourniquet over the distal arm proximally to the elbow. Allen test will be done first and if the hand has a good blood supply through the ulnar artery, the tourniquet pressure is increased 75-100 mmHg over the systolic pressure and the tourniquet time is kept under one hour and the left radial artery will be endoscopically harvested.
During the time of tourniquet inflation, there is ischemia of the forearm with subsequent cellular ischemic changes like; cellular acidosis, cellular edema, and activation of cellular apoptosis. On deflating the tourniquet, there is reperfusion of the limb and development of ischemic / reperfusion injury with a subsequent increase of inflammatory mediators and reactive oxygen species (ROS). These changes may be associated with some hemodynamic instability that might be dangerous, especially in patients with ischemic heart disease (IHD).
- Being tested
- Pneumatic tourniquet, endoscopic left radial artery harvesting
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic tourniquet, endoscopic left radial artery harvestingProcedure or surgery
Endoscopic radial artery harvesting technique is performed after applying a tourniquet over the distal arm proximally to the elbow. The tourniquet pressure is increased 90 mmHg over the systolic pressure and the tourniquet time will be monitored.
he changes in Heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be assessed before and after deflating the tourniquet every 5 minutes for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| endoscopic left radial artery harvesting | single group of 32 patients listed for coronary artery bypass surgery with endoscopic radial artery harvesting. Receives: Procedure: Pneumatic tourniquet, endoscopic left radial artery harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
HR will be recorded at inflating the tourniquet and every five minutes for thirty minutes. HR will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.
Measured: the changes in HR are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.
systolic blood pressure
SBP will be recorded at inflating the tourniquet and every five minutes for thirty minutes. SBP will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.
Measured: the changes in SBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.
diastolic blood pressure
DBP will be recorded at inflating the tourniquet and every five minutes for thirty minutes. DBP will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.
Measured: the changes in DBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.
Secondary outcomes (1)
Phenylephrine use
0 microgram of phenylephrine will be used after deflating the tourniquet if systolic blood pressure is lower than 100mmHg.
Measured: The phenylephrine use ( for SBP less than 100 mmHg) will be recorded for one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start19 May 2022
- Primary completion30 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elsayed M Abdelkarime, MD, Study chair, Lecturer of Anesthesia and Surgical Intensive CareAhmed A Eisa, MD, Study director, Lecturer of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349773
- Sponsor's protocol ID
- MFM-IRB, R.22.02. 1615.R1
- Status last verified
- Aug 2022
- First submitted
- 14 Apr 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data will be available (including data dictionaries). Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pneumatic Tourniquet Technique for Endoscopic Radial Artery Harvest; Does it Affect Patient Hemodynamics?
- ClinicalTrials.gov ID
- NCT05349773
- Acronym / sponsor ID
- MFM-IRB, R.22.02. 1615.R1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 27 Apr 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.
This study aims to investigate the effect of the pneumatic tourniquet technique on the patients' hemodynamics; heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Detailed description
Coronary artery bypass graft surgery (CABG) is the most common cardiac surgical procedure. Radial artery of the non-dominant hand with better ulnar collaterals is preferred over the saphenous vein because of long term patency of the radial artery. Radial artery is the preferred second or third arterial conduits for vessels with sub occlusive stenosis.
There are two techniques of radial artery harvesting; open and endoscopic techniques. Endoscopic radial artery harvesting (ERAH) is increasing and it is possible but the evidence regarding its safety is scarce. ERAH is cosmetically better than the open technique.
ERAH technique is performed after applying a tourniquet over the distal arm proximally to the elbow. Allen test will be done first and if the hand has a good blood supply through the ulnar artery, the tourniquet pressure is increased 75-100 mmHg over the systolic pressure and the tourniquet time is kept under one hour and the left radial artery will be endoscopically harvested.
During the time of tourniquet inflation, there is ischemia of the forearm with subsequent cellular ischemic changes like; cellular acidosis, cellular edema, and activation of cellular apoptosis. On deflating the tourniquet, there is reperfusion of the limb and development of ischemic / reperfusion injury with a subsequent increase of inflammatory mediators and reactive oxygen species (ROS). These changes may be associated with some hemodynamic instability that might be dangerous, especially in patients with ischemic heart disease (IHD).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endoscopic left radial artery harvesting | – | Procedure: Pneumatic tourniquet, endoscopic left radial artery harvestingsingle group of 32 patients listed for coronary artery bypass surgery with endoscopic radial artery harvesting. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are listed for CABG surgery with the use of ERAH technique at cardiothoracic and vascular surgery center (Mansoura University Hospitals, Mansoura University) are eligible for this study.
Key inclusion criteria (1 listed)
- Listed for CABG surgery with the use of ERAH technique.
Key exclusion criteria (3 listed)
- Emergency CABG surgery.
- CABG plus any other cardiac surgery.
- The use of inopressor drugs before ERAH
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 |
|---|---|---|
| Pneumatic tourniquet, endoscopic left radial artery harvestingEndoscopic radial artery harvesting technique is performed after applying a tourniquet over the distal arm proximally to the elbow. The tourniquet pressure is increased 90 mmHg over the systolic pressure and the tourniquet time will be monitored. he changes in Heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be assessed before and after deflating the tourniquet every 5 minutes for 30 minutes. | Procedure or surgery | endoscopic left radial artery harvesting |
Primary outcome
heart rate
Time frame: the changes in HR are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.
HR will be recorded at inflating the tourniquet and every five minutes for thirty minutes. HR will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.
systolic blood pressure
Time frame: the changes in SBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.
SBP will be recorded at inflating the tourniquet and every five minutes for thirty minutes. SBP will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.
diastolic blood pressure
Time frame: the changes in DBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.
DBP will be recorded at inflating the tourniquet and every five minutes for thirty minutes. DBP will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.
1 secondary outcome
Phenylephrine use
Time frame: The phenylephrine use ( for SBP less than 100 mmHg) will be recorded for one 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 5 Aug 2022.
- Individual participant dataSharing planned: Yes. The individual participant data will be available (including data dictionaries). Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
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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.
Elsayed M Abdelkarime, MD study chair
Lecturer of Anesthesia and Surgical Intensive Care
Ahmed A Eisa, MD study director
Lecturer of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Coronary Artery Bypass Graft, run by Mansoura 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 5 Aug 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?
heart rate (time frame: the changes in HR are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.). The study lists 3 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 5 Aug 2022.