Vascular DiseasesNCT04055779
Minimal Inflation Tourniquet Pressure Using Induced Hypotension
An observational study of Vascular Diseases, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Limb occlusion pressure (LOP) and arterial occlusion pressure (AOP) are the terms that mean the lowest tourniquet pressure required to stop the arterial blood flow into the limb distal to the cuff. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- estimation method for arterial occlusion pressure and the limb occlusion pressure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to Nov 2019
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will include the patients scheduled for elective upper limb surgery under general anesthesia who met the inclusion criteria The patient will be scheduled into either group A or B. Group (A): The patients will receive induced hypotensive anaesthesia and the tourniquet pressure will be based on the AOP . Group (B): the patients will receive induced hypotensive anaesthesia and tourniquet pressure will be based on LOP. ,
Who may be able to join
- • ASA physical status I and II.
- Male and female patient
- Age group 20-50 years old
Who cannot join
- • Patient who refuse to participate in the study
- Patients with contraindication of using the tourniquet (e.g. peripheral vascular disease or coronary artery disease sickle cell anemia neuromuscular disorders,)
- Contraindications of using induced hypotensive anesthesia (cerebrovascular disease, Impaired kidney function , chronic liver disease, pregnancy).
- Patients on medications influencing blood flow such as nitrogycerine
- Surgery extends more than 90 minutes.
- Hypertensive patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University Hospital
Banī Suwayf, 6215
Samaa Rashwan, MD, 0201270159125
About this study
Official title: Minimal Inflation Tourniquet Pressure Using Induced Hypotension With Limb Occlusion Pressure Determination or Arterial Occlusion Pressure Estimation in Upper Limb Surgery: A Randomized Double Blinded Comparative Study
Limb occlusion pressure (LOP) and arterial occlusion pressure (AOP) are the terms that mean the lowest tourniquet pressure required to stop the arterial blood flow into the limb distal to the cuff. LOP can be determined manually or automatically by slow cuff inflation until disapper of pulsation with Doppler flow-meter or pulse oximeter
Read the detailed description
The advantages of the tourniquet during upper or lower limb procedures are providing bloodless operative field and so less intra-operative blood lossIt has been reported that using the lowest effective inflation pressure minimize tourniquet induced nerve injury .). Limb occlusion pressure (LOP) and arterial occlusion pressure (AOP) are the terms that mean the lowest tourniquet pressure required to stop the arterial blood flow into the limb distal to the cuff. LOP can be determined manually or automatically by slow cuff inflation until disapper of pulsation with Doppler flowmeter or pulse oximeter .AOP can be estimated by a formula (AOP = [SBP + 10]/KTP) using patient's systolic blood pressure (SBP) and tissue padding coefficient (KTP) values. In both methods, addition of a safety margin to LOP or AOP is recommended for potential hemodynamic fluctuations during surgery
- Conditions
- Vascular Diseases
- Being tested
- estimation method for arterial occlusion pressure, the limb occlusion pressure
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estimation method for arterial occlusion pressureOther
The patients will receive induced hypotensive anaesthesia and the tourniquet pressure will be based on the AOP.the tourniquet pressure will be determined based on the AOP which will be determined by the estimation formula (AOP=[SBP+10]/KTP) . The calculation is based on using initial SBP and tissue padding coefficient values , according to limb circumferences of the patient.After calculation of AOP, tourniquet pressures will be determined by adding a safety margin of 20 mmHg to AOP values(tourniquet pressure=AOP+20 mmHg).
the limb occlusion pressureOther
: using the ultrasound Doppler technique and the tourniquet will be inflated until the arterial pulsations disappear at the side of the operation. This pressure will be recorded as LOP.using the ultrasound Doppler technique and the tourniquet will be inflated until the arterial pulsations disappear at the side of the operation. This pressure will be recorded as LOP .the tourniquet cuff will be inflated to the pressure according to theguidelines of the Association of Perioperative Registered Nurses(AORN) which recommends that a safety margin of 40 mmHg should be added for AOP below 130 mmHg, 60 mmHg for AOP between 131 mmHg and 190 mmHg, and 80 mmHg for AOP above 190 mmHg for adult patients
| Study group | Role | What they receive |
|---|---|---|
| Induced hypotension and arterial occlusion pressure | The patients will receive induced hypotensive anesthesia and the tourniquet pressure will be based on the the tourniquet pressure will be determined based on the AOP which will be determined by the estimation formula (AOP=[SBP+10]/KTP) . The calculation is based on using initial SBP and tissue padding coefficient values , according to limb circumferences of the patient.After calculation of AOP, tourniquet pressures will be determined by adding a safety margin of 20 mmHg to AOP values(tourniquet pressure=AOP+20 mmHg). Receives: Other: estimation method for arterial occlusion pressure; Other: the limb occlusion pressure | |
| induced hypotension and limb occlusion pressure | the patients will receive induced hypotensive anesthesia and the tourniquet pressure will be based on the LOP.using the ultrasound Doppler technique and the tourniquet will be inflated until the arterial pulsations disappear at the side of the operation. This pressure will be recorded as LOP .the tourniquet cuff will be inflated to the pressure according to theguidelines of the Association of Perioperative Registered Nurses(AORN) which recommends that a safety margin of 40 mmHg should be added for AOP below 130 mmHg, 60 mmHg for AOP between 131 mmHg and 190 mmHg, and 80 mmHg for AOP above 190 mmHg for adult patients Receives: Other: estimation method for arterial occlusion pressure; Other: the limb occlusion pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tourniquet inflation pressure
the tourniquet inflation pressure will be determined based on the Arterial occlusion pressure or the limb occlusion pressure
Measured: tourniquet inflation pressures will be recorded at 0, 5, 15, 30, 60, and 120 min.
time required to set the tourniquet inflation pressures
Time needed to estimate AOP or to determine LOP and set the tourniquet cuff pressure.
Measured: one minute before inflation of the tourniquet cuff
Secondary outcomes (1)
tourniquet performance
tourniquet performance as determined by the quality of bloodless surgical field.
Measured: at the middle and end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Aug 2019
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaa Rashwan, Beni-Suef University
- Investigators
- Samaa ak Rashwan, MD, Principal investigator, Assisstant proffesor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055779
- Sponsor's protocol ID
- Beni-Suef University Hospital
- Status last verified
- Aug 2019
- First submitted
- 27 Jul 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Inflation Tourniquet Pressure Using Induced Hypotension With Limb Occlusion Pressure Determination or Arterial Occlusion Pressure Estimation in Upper Limb Surgery: A Randomized Double Blinded Comparative Study
- ClinicalTrials.gov ID
- NCT04055779
- Acronym / sponsor ID
- Beni-Suef University Hospital
- Conditions
- Vascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 14 Aug 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.
Limb occlusion pressure (LOP) and arterial occlusion pressure (AOP) are the terms that mean the lowest tourniquet pressure required to stop the arterial blood flow into the limb distal to the cuff. LOP can be determined manually or automatically by slow cuff inflation until disapper of pulsation with Doppler flow-meter or pulse oximeter
Detailed description
The advantages of the tourniquet during upper or lower limb procedures are providing bloodless operative field and so less intra-operative blood lossIt has been reported that using the lowest effective inflation pressure minimize tourniquet induced nerve injury .). Limb occlusion pressure (LOP) and arterial occlusion pressure (AOP) are the terms that mean the lowest tourniquet pressure required to stop the arterial blood flow into the limb distal to the cuff. LOP can be determined manually or automatically by slow cuff inflation until disapper of pulsation with Doppler flowmeter or pulse oximeter .AOP can be estimated by a formula (AOP = [SBP + 10]/KTP) using patient's systolic blood pressure (SBP) and tissue padding coefficient (KTP) values. In both methods, addition of a safety margin to LOP or AOP is recommended for potential hemodynamic fluctuations during surgery
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induced hypotension and arterial occlusion pressure | – | Other: estimation method for arterial occlusion pressure, Other: the limb occlusion pressureThe patients will receive induced hypotensive anesthesia and the tourniquet pressure will be based on the the tourniquet pressure will be determined based on the AOP which will be determined by the estimation formula (AOP=[SBP+10]/KTP) . The calculation is based on using initial SBP and tissue padding coefficient values , according to limb circumferences of the patient.After calculation of AOP, tourniquet pressures will be determined by adding a safety margin of 20 mmHg to AOP values(tourniquet pressure=AOP+20 mmHg). |
| induced hypotension and limb occlusion pressure | – | Other: estimation method for arterial occlusion pressure, Other: the limb occlusion pressurethe patients will receive induced hypotensive anesthesia and the tourniquet pressure will be based on the LOP.using the ultrasound Doppler technique and the tourniquet will be inflated until the arterial pulsations disappear at the side of the operation. This pressure will be recorded as LOP .the tourniquet cuff will be inflated to the pressure according to theguidelines of the Association of Perioperative Registered Nurses(AORN) which recommends that a safety margin of 40 mmHg should be added for AOP below 130 mmHg, 60 mmHg for AOP between 131 mmHg and 190 mmHg, and 80 mmHg for AOP above 190 mmHg for adult patients |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include the patients scheduled for elective upper limb surgery under general anesthesia who met the inclusion criteria The patient will be scheduled into either group A or B. Group (A): The patients will receive induced hypotensive anaesthesia and the tourniquet pressure will be based on the AOP . Group (B): the patients will receive induced hypotensive anaesthesia and tourniquet pressure will be based on LOP. ,
Key inclusion criteria (3 listed)
- • ASA physical status I and II.
Key exclusion criteria (6 listed)
- • Patient who refuse to participate in the study
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 |
|---|---|---|
| estimation method for arterial occlusion pressureThe patients will receive induced hypotensive anaesthesia and the tourniquet pressure will be based on the AOP.the tourniquet pressure will be determined based on the AOP which will be determined by the estimation formula (AOP=[SBP+10]/KTP) . The calculation is based on using initial SBP and tissue padding coefficient values , according to limb circumferences of the patient.After calculation of AOP, tourniquet pressures will be determined by adding a safety margin of 20 mmHg to AOP values(tourniquet pressure=AOP+20 mmHg). | Other | Induced hypotension and arterial occlusion pressure, induced hypotension and limb occlusion pressure |
| the limb occlusion pressure: using the ultrasound Doppler technique and the tourniquet will be inflated until the arterial pulsations disappear at the side of the operation. This pressure will be recorded as LOP.using the ultrasound Doppler technique and the tourniquet will be inflated until the arterial pulsations disappear at the side of the operation. This pressure will be recorded as LOP .the tourniquet cuff will be inflated to the pressure according to theguidelines of the Association of Perioperative Registered Nurses(AORN) which recommends that a safety margin of 40 mmHg should be added for AOP below 130 mmHg, 60 mmHg for AOP between 131 mmHg and 190 mmHg, and 80 mmHg for AOP above 190 mmHg for adult patients | Other | Induced hypotension and arterial occlusion pressure, induced hypotension and limb occlusion pressure |
Primary outcome
Tourniquet inflation pressure
Time frame: tourniquet inflation pressures will be recorded at 0, 5, 15, 30, 60, and 120 min.
the tourniquet inflation pressure will be determined based on the Arterial occlusion pressure or the limb occlusion pressure
time required to set the tourniquet inflation pressures
Time frame: one minute before inflation of the tourniquet cuff
Time needed to estimate AOP or to determine LOP and set the tourniquet cuff pressure.
1 secondary outcome
tourniquet performance
Time frame: at the middle and end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- 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.
Samaa ak Rashwan, MD principal investigator
Assisstant proffesor of anesthesia
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 Vascular Diseases, run by Beni-Suef 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 3 inclusion and 6 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 14 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samaa ak Rashwan, MD (020120159125, samakassemrashwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tourniquet inflation pressure (time frame: tourniquet inflation pressures will be recorded at 0, 5, 15, 30, 60, and 120 min.). 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 14 Aug 2019.