Vascular DiseasesNCT03706859
Two Mathematical Methods to Estimate Arterial Occlusion Pressure and Tourniquet Effectiveness in Lower Limb Surgery
A study testing Pneumatic tourniquet inflation pressure in people with Vascular Diseases, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Pneumatic tourniquets are widely used not only to reduce blood loss and to ensure optimal operating conditions during extremity surgery, but also in regional anesthesia (local intravenous) vein puncture and to control life or limb threatening conditions. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Pneumatic tourniquet inflation pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2018to 15 Nov 2018
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult patients 18-40 years old, (ASA I-II), scheduled for knee arthroscopy under general anesthesia with pneumatic tourniquet around the thigh,
Who cannot join
- outside the age range, hypertensive, diabetic, complaining of any lower limb claudications, any vascular disease, hemolytic blood disorders or hypercoagulabilty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Two Mathematical Methods to Estimate Arterial Occlusion Pressure and Tourniquet Effectiveness in Lower Limb Surgery: Randomized Comparative Study
Pneumatic tourniquets are widely used not only to reduce blood loss and to ensure optimal operating conditions during extremity surgery, but also in regional anesthesia (local intravenous) vein puncture and to control life or limb threatening conditions. However, compression of the tissues under a tourniquet is associated with soft tissue damage involving the skin, vessels, muscles, and most importantly, nerves, and are commonly pressure related and can be affected by tourniquet time as well. Therefore, the "minimal tourniquet inflation pressure" necessary to provide a bloodless field has been suggested to minimize the risk of complications from excessive inflation pressure. Arterial occlusion pressure (AOP) is the lowest pneumatic tourniquet inflation pressure required to stop the arterial blood flow into the limb, and its usage has been shown to be useful in optimizing tourniquet cuff pressures. The pressure to which a pneumatic tourniquet cuff should be inflated depends on a number of variables, including the patient's age, skin, blood pressure and the shape and size of the extremity in question, as well as the dimensions of the cuff. One of the estimation method for AOP is based on systolic blood pressure (SBP) and tissue padding coefficient (KTP) values (AOP=[SBP+10]/KTP) according to extremity circumferences. Unver B. et al., used this method to estimate effective tourniquet pressure in total knee replacement under hypotensive general anesthesia tourniquet pressure achieved was 169.7±7.9 mmHg, while Tuncali et al., tested it again in different lower limb surgeries under general or neuraxial anesthesia with normotensive techniques and the achieved maximal tourniquet pressures used was 173.3±15.6 mmHg. Hong-yun Liu et al., established a new occlusion pressure mathematical model for the upper limb based on the correlation analysis between several possible influencing parameters and the minimal pneumatic tourniquet pressure.
Read the detailed description
After ethical committee approval and informed consent from the patients, 80 adult patients 18-40 years old, (ASA I-II), scheduled for knee arthroscopy under general anesthesia with pneumatic tourniquet around the thigh, will be randomly allocated (using closed opaque envelop) into one of two groups:
- Group (A): where the pneumatic tourniquet inflated 20 mmHg above the arterial occlusion pressure which will be estimated using the equation of Unver B. et al., [1]: (AOP=[SBP+10]/KTP)
- Group (B): where the pneumatic tourniquet inflated 20 mmHg above the arterial occlusion pressure which will be estimated using the equation of Hong-yun Liu et al., [2]: (AOP = 17.986 + 3.158X1 + 0.408X2) Patients will be excluded from the study if they are outside the age range, hypertensive, diabetic, complaining of any lower limb claudications, any vascular disease, hemolytic blood disorders or hypercoagulability.
Upon arrival to the operating room, standard monitoring will be attached (5 lead ECG, pulse oximeter and non-invasive blood pressure) followed by a wide-bore canula will be inserted a big vein in the upper limb. General anesthesia will be induced using fentanyl 1 mcg/kg and propofol 2-3 mg/kg laryngeal mask airway device will be inserted after atracurium 0.5 mg/kg and lungs will be mechanically ventilated to maintain end-tidal CO2 at 36-40 mmHg and maintenance of anesthesia will be achieved using isoflurane 1-2 volume %. Hemodynamic stabilization will be assured and systolic blood pressure will be maintained within the pre-induction values ± 20% using intravenous fluid infusion and titration of inhalational anesthetics.
In all patients, the thigh circumference will be measured 20 cm proximal to the superior pole of the patella then, pneumatic the tourniquet cuff will be placed (deflated) around the thigh with the distal edge 15 cm proximal to the proximal pole of the patella. The tissue padding coefficients based on limb circumferences will be calculated in all patients of group (A) according to table (1) [3].
After three successive stable systolic blood pressure reading (5 minutes apart), an initial systolic blood pressure [initial SBP] reading will take and estimated arterial occlusion pressure (AOP) will be quickly calculated according to one of the previously mentioned equation followed limb exsanguination using an Esmarch bandage, then the tourniquet cuff will be inflated to a safety margin pressure 20 mmHg above the calculated (AOP) [3] which will be the [initial tourniquet pressure]. The time between the initial SBP taking and tourniquet inflation will be measured [initial SBP-to- tourniquet inflation time]. The absence of arterial flow in the lower limb is assured using Doppler probe (HD, Philips) positioned, by an independent anesthetist, at either the dorsalis pedis artery or the posterior tibial artery on the foot to monitor arterial flow distal to the tourniquet. If any arterial flow sound will be heard, the estimated tourniquet pressure will be considered insufficient and the patient will excluded from the study. When no arterial blood flow is secured, the surgeon (blinded to the groups) will allowed to start and will be asked to rate the bloodless surgical field using a 4-point scale [1 (Excellent) = No blood in the surgical field, 2 (Good) = Some blood in the surgical field but no interference with surgery, 3 (Fair) = Blood in the surgical field but no significant interference with surgery, 4 (Poor) = Blood in the surgical field obscures the view] [3] at the beginning, in the middle, and at the end of the surgical procedure.
During the surgery, systolic blood pressure will be measured every 5 minutes and the tourniquet inflation pressure will be always kept 20 mmHg above the SBP.
Surgical procedure and anesthetic management were performed by the same surgical and anesthesia teams respectively. The attending anesthesiologist was aware of the allocated group, but the data analyst, surgeon and the patients were blinded to group allocation.
All the patients will be examined one day after surgery for any complications associated with the tourniquet, (e.g. tissue damage, nerve palsy, lower limb blood flow).
The following will be measured:
- Patient's age, weight and gender and lower limb circumference?
- Operative duration and tourniquet time.
- Initial SBP-to- tourniquet inflation time
- Primary outcome: initial and maximal SBP, initial and maximum tourniquet inflation pressure.
- Secondary outcome: surgeon rating of the bloodlessness of the surgical field.
- Any tourniquet associated complications.
- Conditions
- Vascular Diseases
- Being tested
- Pneumatic tourniquet inflation 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.
Pneumatic tourniquet inflation pressureProcedure or surgery
Pneumatic tourniquet inflation pressure estimation using two different mathematical equations
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet inflation pressure method 1 | Experimental | the pneumatic tourniquet inflation pressure at 20 mmHg above the arterial occlusion pressure which will be estimated using the equation of Unver B. et al.,: (AOP=[SBP+10]/KTP) Receives: Procedure: Pneumatic tourniquet inflation pressure |
| Tourniquet inflation pressure method 2 | Active comparator | the pneumatic tourniquet inflateion pressure at 20 mmHg above the arterial occlusion pressure which will be estimated using the equation of Hong-yun Liu et al.,: (AOP = 17.986 + 3.158X1 + 0.408X2) Receives: Procedure: Pneumatic tourniquet inflation pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure,
initial and maximal Systolic Blood Pressure,
Measured: baseline and maximum inflation
tourniquet inflation pressure.
initial and maximum tourniquet inflation pressure.
Measured: baseline and maximum inflation
Secondary outcomes (1)
surgeon rating of the bloodlessness of the surgical field.
surgeon rating of the bloodlessness of the surgical field.
Measured: 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 posted16 Oct 2018
- Study start12 May 2018
- Primary completion12 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaa A. Kasem, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706859
- Sponsor's protocol ID
- FM-BSU REC 005/2018
- Status last verified
- Jan 2019
- First submitted
- 9 Oct 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Unver B, Karatosun V, Tuncali B. Effects of tourniquet pressure on rehabilitation outcomes in patients undergoing total knee arthroplasty. Orthop Nurs. 2013 Jul-Aug;32(4):217-22. doi: 10.1097/NOR.0b013e31829aef2a.
PubMed 23881019Liu HY, Guo JY, Zhang ZB, Li KY, Wang WD. Development of adaptive pneumatic tourniquet systems based on minimal inflation pressure for upper limb surgeries. Biomed Eng Online. 2013 Sep 23;12:92. doi: 10.1186/1475-925X-12-92.
PubMed 24053348Tuncali B, Boya H, Kayhan Z, Arac S, Camurdan MA. Clinical utilization of arterial occlusion pressure estimation method in lower limb surgery: effectiveness of tourniquet pressures. Acta Orthop Traumatol Turc. 2016;50(2):171-7. doi: 10.3944/AOTT.2015.15.0175.
PubMed 26969952Kasem SA, Al Menesy T, Badawy AA, Abd Elmawgoud A, Adel G, Badawy YA. Comparison between two mathematical methods to estimate arterial occlusion pressure and tourniquet effectiveness in lower limb surgery: a prospective, randomized, double blind, comparative study. J Clin Monit Comput. 2020 Aug;34(4):675-681. doi: 10.1007/s10877-019-00366-0. Epub 2019 Jul 25.
PubMed 31346900
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Mathematical Methods to Estimate Arterial Occlusion Pressure and Tourniquet Effectiveness in Lower Limb Surgery: Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT03706859
- Acronym / sponsor ID
- FM-BSU REC 005/2018
- Conditions
- Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 12 May 2018 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 16 Oct 2018 (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.
Pneumatic tourniquets are widely used not only to reduce blood loss and to ensure optimal operating conditions during extremity surgery, but also in regional anesthesia (local intravenous) vein puncture and to control life or limb threatening conditions. However, compression of the tissues under a tourniquet is associated with soft tissue damage involving the skin, vessels, muscles, and most importantly, nerves, and are commonly pressure related and can be affected by tourniquet time as well. Therefore, the "minimal tourniquet inflation pressure" necessary to provide a bloodless field has been suggested to minimize the risk of complications from excessive inflation pressure. Arterial occlusion pressure (AOP) is the lowest pneumatic tourniquet inflation pressure required to stop the arterial blood flow into the limb, and its usage has been shown to be useful in optimizing tourniquet cuff pressures. The pressure to which a pneumatic tourniquet cuff should be inflated depends on a number of variables, including the patient's age, skin, blood pressure and the shape and size of the extremity in question, as well as the dimensions of the cuff. One of the estimation method for AOP is based on systolic blood pressure (SBP) and tissue padding coefficient (KTP) values (AOP=[SBP+10]/KTP) according to extremity circumferences. Unver B. et al., used this method to estimate effective tourniquet pressure in total knee replacement under hypotensive general anesthesia tourniquet pressure achieved was 169.7±7.9 mmHg, while Tuncali et al., tested it again in different lower limb surgeries under general or neuraxial anesthesia with normotensive techniques and the achieved maximal tourniquet pressures used was 173.3±15.6 mmHg. Hong-yun Liu et al., established a new occlusion pressure mathematical model for the upper limb based on the correlation analysis between several possible influencing parameters and the minimal pneumatic tourniquet pressure.
Detailed description
After ethical committee approval and informed consent from the patients, 80 adult patients 18-40 years old, (ASA I-II), scheduled for knee arthroscopy under general anesthesia with pneumatic tourniquet around the thigh, will be randomly allocated (using closed opaque envelop) into one of two groups:
- Group (A): where the pneumatic tourniquet inflated 20 mmHg above the arterial occlusion pressure which will be estimated using the equation of Unver B. et al., [1]: (AOP=[SBP+10]/KTP)
- Group (B): where the pneumatic tourniquet inflated 20 mmHg above the arterial occlusion pressure which will be estimated using the equation of Hong-yun Liu et al., [2]: (AOP = 17.986 + 3.158X1 + 0.408X2) Patients will be excluded from the study if they are outside the age range, hypertensive, diabetic, complaining of any lower limb claudications, any vascular disease, hemolytic blood disorders or hypercoagulability.
Upon arrival to the operating room, standard monitoring will be attached (5 lead ECG, pulse oximeter and non-invasive blood pressure) followed by a wide-bore canula will be inserted a big vein in the upper limb. General anesthesia will be induced using fentanyl 1 mcg/kg and propofol 2-3 mg/kg laryngeal mask airway device will be inserted after atracurium 0.5 mg/kg and lungs will be mechanically ventilated to maintain end-tidal CO2 at 36-40 mmHg and maintenance of anesthesia will be achieved using isoflurane 1-2 volume %. Hemodynamic stabilization will be assured and systolic blood pressure will be maintained within the pre-induction values ± 20% using intravenous fluid infusion and titration of inhalational anesthetics.
In all patients, the thigh circumference will be measured 20 cm proximal to the superior pole of the patella then, pneumatic the tourniquet cuff will be placed (deflated) around the thigh with the distal edge 15 cm proximal to the proximal pole of the patella. The tissue padding coefficients based on limb circumferences will be calculated in all patients of group (A) according to table (1) [3].
After three successive stable systolic blood pressure reading (5 minutes apart), an initial systolic blood pressure [initial SBP] reading will take and estimated arterial occlusion pressure (AOP) will be quickly calculated according to one of the previously mentioned equation followed limb exsanguination using an Esmarch bandage, then the tourniquet cuff will be inflated to a safety margin pressure 20 mmHg above the calculated (AOP) [3] which will be the [initial tourniquet pressure]. The time between the initial SBP taking and tourniquet inflation will be measured [initial SBP-to- tourniquet inflation time]. The absence of arterial flow in the lower limb is assured using Doppler probe (HD, Philips) positioned, by an independent anesthetist, at either the dorsalis pedis artery or the posterior tibial artery on the foot to monitor arterial flow distal to the tourniquet. If any arterial flow sound will be heard, the estimated tourniquet pressure will be considered insufficient and the patient will excluded from the study. When no arterial blood flow is secured, the surgeon (blinded to the groups) will allowed to start and will be asked to rate the bloodless surgical field using a 4-point scale [1 (Excellent) = No blood in the surgical field, 2 (Good) = Some blood in the surgical field but no interference with surgery, 3 (Fair) = Blood in the surgical field but no significant interference with surgery, 4 (Poor) = Blood in the surgical field obscures the view] [3] at the beginning, in the middle, and at the end of the surgical procedure.
During the surgery, systolic blood pressure will be measured every 5 minutes and the tourniquet inflation pressure will be always kept 20 mmHg above the SBP.
Surgical procedure and anesthetic management were performed by the same surgical and anesthesia teams respectively. The attending anesthesiologist was aware of the allocated group, but the data analyst, surgeon and the patients were blinded to group allocation.
All the patients will be examined one day after surgery for any complications associated with the tourniquet, (e.g. tissue damage, nerve palsy, lower limb blood flow).
The following will be measured:
- Patient's age, weight and gender and lower limb circumference?
- Operative duration and tourniquet time.
- Initial SBP-to- tourniquet inflation time
- Primary outcome: initial and maximal SBP, initial and maximum tourniquet inflation pressure.
- Secondary outcome: surgeon rating of the bloodlessness of the surgical field.
- Any tourniquet associated complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourniquet inflation pressure method 1 | Experimental | Procedure: Pneumatic tourniquet inflation pressurethe pneumatic tourniquet inflation pressure at 20 mmHg above the arterial occlusion pressure which will be estimated using the equation of Unver B. et al.,: (AOP=[SBP+10]/KTP) |
| Tourniquet inflation pressure method 2 | Active comparator | Procedure: Pneumatic tourniquet inflation pressurethe pneumatic tourniquet inflateion pressure at 20 mmHg above the arterial occlusion pressure which will be estimated using the equation of Hong-yun Liu et al.,: (AOP = 17.986 + 3.158X1 + 0.408X2) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult patients 18-40 years old, (ASA I-II), scheduled for knee arthroscopy under general anesthesia with pneumatic tourniquet around the thigh,
Key exclusion criteria (1 listed)
- outside the age range, hypertensive, diabetic, complaining of any lower limb claudications, any vascular disease, hemolytic blood disorders or hypercoagulabilty.
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 inflation pressurePneumatic tourniquet inflation pressure estimation using two different mathematical equations | Procedure or surgery | Tourniquet inflation pressure method 1, Tourniquet inflation pressure method 2 |
Primary outcome
Systolic Blood Pressure,
Time frame: baseline and maximum inflation
initial and maximal Systolic Blood Pressure,
tourniquet inflation pressure.
Time frame: baseline and maximum inflation
initial and maximum tourniquet inflation pressure.
1 secondary outcome
surgeon rating of the bloodlessness of the surgical field.
Time frame: middle and end of surgery
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 23 Jan 2019.
- Background: PubMed 23881019Unver B, Karatosun V, Tuncali B. Effects of tourniquet pressure on rehabilitation outcomes in patients undergoing total knee arthroplasty. Orthop Nurs. 2013 Jul-Aug;32(4):217-22. doi: 10.1097/NOR.0b013e31829aef2a.
- Background: PubMed 24053348Liu HY, Guo JY, Zhang ZB, Li KY, Wang WD. Development of adaptive pneumatic tourniquet systems based on minimal inflation pressure for upper limb surgeries. Biomed Eng Online. 2013 Sep 23;12:92. doi: 10.1186/1475-925X-12-92.
- Background: PubMed 26969952Tuncali B, Boya H, Kayhan Z, Arac S, Camurdan MA. Clinical utilization of arterial occlusion pressure estimation method in lower limb surgery: effectiveness of tourniquet pressures. Acta Orthop Traumatol Turc. 2016;50(2):171-7. doi: 10.3944/AOTT.2015.15.0175.
- Derived from this study: PubMed 31346900Kasem SA, Al Menesy T, Badawy AA, Abd Elmawgoud A, Adel G, Badawy YA. Comparison between two mathematical methods to estimate arterial occlusion pressure and tourniquet effectiveness in lower limb surgery: a prospective, randomized, double blind, comparative study. J Clin Monit Comput. 2020 Aug;34(4):675-681. doi: 10.1007/s10877-019-00366-0. Epub 2019 Jul 25.
- Individual participant dataSharing planned: Undecided
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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 Pneumatic tourniquet inflation pressure in people with 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 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: finished, as of the sponsor's last update on 23 Jan 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?
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?
Systolic Blood Pressure, (time frame: baseline and maximum inflation). 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?
On the ClinicalTrials.gov record for NCT03706859, which also lists 4 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 23 Jan 2019.