Initial Systolic Blood Pressure (mmHg)NCT04710225

Does Anesthetic Technique Affect Pneumatic Tourniquet Pressures in Upper Limb Fracture Surgery?

A study testing Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) setting in people with Initial Systolic Blood Pressure (mmHg) and Arterial Occlusion Pressure (mmHg), run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Initial Systolic Blood Pressure (mmHg), Arterial Occlusion Pressure (mmHg), Tourniquet Time (Minutes)
What is being tested?: Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) setting
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 8 Oct 2019to 9 Jan 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 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients undergoing upper limb fracture surgery

Who cannot join

The age below 18 and above 85 years,
American Society of Anesthesiology (ASA) physical status >2
Any contraindication to axillary block or general anesthesia
Any contraindication to tourniquet use
Adverse reaction history to anesthetic drugs
Severe anemia
Refusal to give informed consent

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Baskent University
Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Does Anesthetic Technique Affect Pneumatic Tourniquet Pressures in Upper Limb Fracture Surgery? A Comparison of General Anesthesia and Axillary Brachial Plexus Block

In pneumatic tourniquet applications, the use of an individualized, lowest-effective tourniquet pressure (TP) has been recommended, in order to avoid pressure related complications. The aim of this study is to compare the effects of general anesthesia and axillary block on arterial occlusion pressure (AOP) estimation based TP settings in upper limb fracture surgery.

After, ethical committee approval 80 adult patients undergoing upper limb fracture surgery who gave their signed informed consent will be included. The age below 18 and above 85 years, American Society of Anesthesiology (ASA) physical status >2, any contraindication to axillary block or GA, adverse reaction history to anesthetic drugs, severe anemia, and refusal to give informed consent will be the exclusion criteria. The patients will be randomized to one of two study groups using a computer-generated randomization list to receive GA (Group 1) and axillary block (Group 2).

Main endpoints are initial and maximal blood pressures, AOP, initial and maximal TPs, and tourniquet time. Additionally, the surgeon will evaluate the quality of bloodless surgical area with respect to the amount of blood 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) at the beginning, in the middle, and at the end of the surgical procedure. The patients will be observed for signs of tourniquet related complications by a blind investigator. SPSS 20.0 for Windows is used for data analysis. The t test and the χ2 test will be used for continuous and categorical data respectively. A P value below 0.05 will be considered as statistically significant.

Conditions: Initial Systolic Blood Pressure (mmHg), Arterial Occlusion Pressure (mmHg), Tourniquet Time (Minutes), Quality of Bloodless Surgical Field (4 Point Scale), Initial Tourniquet Pressure (mmHg), Maximal Systolic Blood Pressure (mmHg)
Being tested: Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) setting
Keywords: Pneumatic tourniquet, Pressure, Upper extremity, General anesthesia, Axillary brachial plexus block.
Medical subject headings: Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) settingProcedure or surgery
Upper limb fracture surgery will be performed with the aid of a pneumatic tourniquet.
The cuff (11 cm) of the tourniquet will be placed around the arm with the distal edge 5 cm above the olecranon. AOP estimation formula according to initial systolic blood pressure (SBP) and Tissue Padding Coefficient (KTP) values (AOP= [SBP+10]/KTP) from a list (Table 1) will be used to calculate AOP (17). After calculation of AOP, a safety margin of 20 mmHg will be added to AOP to determine the TP (TP=AOP+20 mm Hg). Exsanguination of the limb will be provided with an Esmarch bandage and the cuff will be inflated to the predetermined TP. TP will be manually raised in response to each 10 mmHg increase in SBP during the surgical procedure.

Study groups in NCT04710225
Study group	Role	What they receive
Group 1 (General anesthesia group)	Active comparator	Upper limb fracture surgery will be performed with the aid of pneumatic tourniquet. General anesthesia will be induced with intravenous (IV) thiopental sodium and fentanyl. Rocuronium will be used as the neuromuscular blocking agent. Endotracheal tube will be placed and anesthesia will be maintained with sevoflurane and IV fentanyl while the lungs were ventilated with O2-N2O (50-50%) to achieve an EtCO2 at 30-35 mm Hg. Receives: Procedure: Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) setting
Group 2 (Multiple injection axillary block group)	Active comparator	Multiple injection axillary block will be performed with the aid of a nerve stimulator. When the slight twitching of the motor response from the relevant muscles is achieved (at 0.4 mA, 2Hz, 0.1 ms) % 18-20 ml of Bupivacaine 0.5 (90-100 mg) will be injected. Receives: Procedure: Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) setting

What is being measured

The primary outcome is the main question the study is designed to answer.

Initial and maximal systolic blood pressure (mmHg)
Initial and maximal systolic blood pressures define the systolic blood pressures measured and recorded by the patient monitor just before tourniquet inflation and during tourniquet application respectively.
Measured: Intraoperative
Arterial occlusion pressure (mmHg)
Arterial occlusion pressure is the minimal tourniquet pressure required to cease arterial blood flow to the limb and calculated with AOP estimation formula according to initial SBP and Tissue Padding Coefficient (KTP) values (AOP= [SBP+10]/KTP) from a list.
Measured: Intraoperative
Initial and maximal tourniquet pressures (mmHg)
Initial and maximal tourniquet pressures define first adjusted and maximal tourniquet pressures during surgery.
Measured: Intraoperative
Tourniquet time (minute)
Tourniquet time defines the time period between the inflation and deflation of the tourniquet cuff at the beginning and end of the surgery respectively.
Measured: Intraoperative

Secondary outcomes (1)

The quality of bloodless surgical area
The quality of bloodless surgical area will be evaluated by the surgeon respect to the amount of blood 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) at the beginning, in the middle, and at the end of the surgical procedure.
Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 20199 Jan 2021

First posted14 Jan 2021
Study start8 Oct 2019
Primary completion9 Jan 2021
Study completion9 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (33)Papers the sponsor has linked to this study.
Other trials for Initial Systolic Blood Pressure (mmHg)Studies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04710225
Sponsor's protocol ID: KA19/326
Status last verified: Jan 2021
First submitted: 10 Jan 2021
Last updated: 14 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Estebe JP, Davies JM, Richebe P. The pneumatic tourniquet: mechanical, ischaemia-reperfusion and systemic effects. Eur J Anaesthesiol. 2011 Jun;28(6):404-11. doi: 10.1097/EJA.0b013e328346d5a9.
PubMed 21502865
Odinsson A, Finsen V. Tourniquet use and its complications in Norway. J Bone Joint Surg Br. 2006 Aug;88(8):1090-2. doi: 10.1302/0301-620X.88B8.17668.
PubMed 16877612
Olivecrona C, Blomfeldt R, Ponzer S, Stanford BR, Nilsson BY. Tourniquet cuff pressure and nerve injury in knee arthroplasty in a bloodless field: a neurophysiological study. Acta Orthop. 2013 Apr;84(2):159-64. doi: 10.3109/17453674.2013.782525. Epub 2013 Mar 14.
PubMed 23485070
Olivecrona C, Ponzer S, Hamberg P, Blomfeldt R. Lower tourniquet cuff pressure reduces postoperative wound complications after total knee arthroplasty: a randomized controlled study of 164 patients. J Bone Joint Surg Am. 2012 Dec 19;94(24):2216-21. doi: 10.2106/JBJS.K.01492.
PubMed 23318611
Boya H, Tuncali B, Ozcan O, Arac S, Tuncay C. Practice of tourniquet use in Turkey: a pilot study. Acta Orthop Traumatol Turc. 2016;50(2):162-70. doi: 10.3944/AOTT.2015.15.0066.
PubMed 26969951
Ding L, Ding CY, Wang YL, Wang ML, Qian XH, Huang L, Xie XE, Ji HZ. Application effect of pneumatic tourniquet with individualized pressure setting in orthopaedic surgery of extremities: A meta-analysis. J Adv Nurs. 2019 Dec;75(12):3424-3433. doi: 10.1111/jan.14196. Epub 2019 Oct 15.
PubMed 31524296
Van Roekel HE, Thurston AJ. Tourniquet pressure: the effect of limb circumference and systolic blood pressure. J Hand Surg Br. 1985 Jun;10(2):142-4. doi: 10.1016/0266-7681(85)90002-6.
PubMed 4031590
Pauers RS, Carocci MA. Low pressure pneumatic tourniquets: effectiveness at minimum recommended inflation pressures. J Foot Ankle Surg. 1994 Nov-Dec;33(6):605-9.
PubMed 7894409
Shaw JA, Murray DG. The relationship between tourniquet pressure and underlying soft-tissue pressure in the thigh. J Bone Joint Surg Am. 1982 Oct;64(8):1148-52.
PubMed 7130227
McLaren AC, Rorabeck CH. The pressure distribution under tourniquets. J Bone Joint Surg Am. 1985 Mar;67(3):433-8.
PubMed 3972869
Hargens AR, McClure AG, Skyhar MJ, Lieber RL, Gershuni DH, Akeson WH. Local compression patterns beneath pneumatic tourniquets applied to arms and thighs of human cadavera. J Orthop Res. 1987;5(2):247-52. doi: 10.1002/jor.1100050211.
PubMed 3572594
Graham B, Breault MJ, McEwen JA, McGraw RW. Perineural pressures under the pneumatic tourniquet in the upper extremity. J Hand Surg Br. 1992 Jun;17(3):262-6. doi: 10.1016/0266-7681(92)90111-e.
PubMed 1624856
Estersohn HS, Sourifman HA. The minimum effective midthigh tourniquet pressure. J Foot Surg. 1982 Winter;21(4):281-4.
PubMed 7186917
Newman RJ, Muirhead A. A safe and effective low pressure tourniquet. A prospective evaluation. J Bone Joint Surg Br. 1986 Aug;68(4):625-8. doi: 10.1302/0301-620X.68B4.3525572.
PubMed 3525572
Tuncali B, Karci A, Bacakoglu AK, Tuncali BE, Ekin A. Controlled hypotension and minimal inflation pressure: a new approach for pneumatic tourniquet application in upper limb surgery. Anesth Analg. 2003 Nov;97(5):1529-1532. doi: 10.1213/01.ANE.0000081660.97731.91.
PubMed 14570681

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Anesthetic Technique Affect Pneumatic Tourniquet Pressures in Upper Limb Fracture Surgery? A Comparison of General Anesthesia and Axillary Brachial Plexus Block
ClinicalTrials.gov ID: NCT04710225
Acronym / sponsor ID: KA19/326
Conditions: Initial Systolic Blood Pressure (mmHg), Arterial Occlusion Pressure (mmHg), Tourniquet Time (Minutes), Quality of Bloodless Surgical Field (4 Point Scale), Initial Tourniquet Pressure (mmHg), Maximal Systolic Blood Pressure (mmHg)
Keywords: Pneumatic tourniquet, Pressure, Upper extremity, General anesthesia, Axillary brachial plexus block.
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Baskent University Ankara HospitalUniversity, hospital or other
Study start: 8 Oct 2019 (actual)
Primary completion: 9 Jan 2021 (actual)
Study completion: 9 Jan 2021 (actual)
First posted: 14 Jan 2021 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group 1 (General anesthesia group)	Active comparator	Procedure: Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) settingUpper limb fracture surgery will be performed with the aid of pneumatic tourniquet. General anesthesia will be induced with intravenous (IV) thiopental sodium and fentanyl. Rocuronium will be used as the neuromuscular blocking agent. Endotracheal tube will be placed and anesthesia will be maintained with sevoflurane and IV fentanyl while the lungs were ventilated with O2-N2O (50-50%) to achieve an EtCO2 at 30-35 mm Hg.
Group 2 (Multiple injection axillary block group)	Active comparator	Procedure: Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) settingMultiple injection axillary block will be performed with the aid of a nerve stimulator. When the slight twitching of the motor response from the relevant muscles is achieved (at 0.4 mA, 2Hz, 0.1 ms) % 18-20 ml of Bupivacaine 0.5 (90-100 mg) will be injected.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients undergoing upper limb fracture surgery

Key exclusion criteria (7 listed)

The age below 18 and above 85 years,
American Society of Anesthesiology (ASA) physical status >2
Any contraindication to axillary block or general anesthesia
Any contraindication to tourniquet use
Adverse reaction history to anesthetic drugs

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
Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) settingUpper limb fracture surgery will be performed with the aid of a pneumatic tourniquet. The cuff (11 cm) of the tourniquet will be placed around the arm with the distal edge 5 cm above the olecranon. AOP estimation formula according to initial systolic blood pressure (SBP) and Tissue Padding Coefficient (KTP) values (AOP= [SBP+10]/KTP) from a list (Table 1) will be used to calculate AOP (17). After calculation of AOP, a safety margin of 20 mmHg will be added to AOP to determine the TP (TP=AOP+20 mm Hg). Exsanguination of the limb will be provided with an Esmarch bandage and the cuff will be inflated to the predetermined TP. TP will be manually raised in response to each 10 mmHg increase in SBP during the surgical procedure.	Procedure or surgery	Group 1 (General anesthesia group), Group 2 (Multiple injection axillary block group)

Primary outcome

Initial and maximal systolic blood pressure (mmHg)
Time frame: Intraoperative
Initial and maximal systolic blood pressures define the systolic blood pressures measured and recorded by the patient monitor just before tourniquet inflation and during tourniquet application respectively.
Arterial occlusion pressure (mmHg)
Time frame: Intraoperative
Arterial occlusion pressure is the minimal tourniquet pressure required to cease arterial blood flow to the limb and calculated with AOP estimation formula according to initial SBP and Tissue Padding Coefficient (KTP) values (AOP= [SBP+10]/KTP) from a list.
Initial and maximal tourniquet pressures (mmHg)
Time frame: Intraoperative
Initial and maximal tourniquet pressures define first adjusted and maximal tourniquet pressures during surgery.
Tourniquet time (minute)
Time frame: Intraoperative
Tourniquet time defines the time period between the inflation and deflation of the tourniquet cuff at the beginning and end of the surgery respectively.

1 secondary outcome

The quality of bloodless surgical area
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 14 Jan 2021.
Background: PubMed 21502865Estebe JP, Davies JM, Richebe P. The pneumatic tourniquet: mechanical, ischaemia-reperfusion and systemic effects. Eur J Anaesthesiol. 2011 Jun;28(6):404-11. doi: 10.1097/EJA.0b013e328346d5a9.
Background: PubMed 16877612Odinsson A, Finsen V. Tourniquet use and its complications in Norway. J Bone Joint Surg Br. 2006 Aug;88(8):1090-2. doi: 10.1302/0301-620X.88B8.17668.
Background: PubMed 23485070Olivecrona C, Blomfeldt R, Ponzer S, Stanford BR, Nilsson BY. Tourniquet cuff pressure and nerve injury in knee arthroplasty in a bloodless field: a neurophysiological study. Acta Orthop. 2013 Apr;84(2):159-64. doi: 10.3109/17453674.2013.782525. Epub 2013 Mar 14.
Background: PubMed 23318611Olivecrona C, Ponzer S, Hamberg P, Blomfeldt R. Lower tourniquet cuff pressure reduces postoperative wound complications after total knee arthroplasty: a randomized controlled study of 164 patients. J Bone Joint Surg Am. 2012 Dec 19;94(24):2216-21. doi: 10.2106/JBJS.K.01492.
Background: PubMed 26969951Boya H, Tuncali B, Ozcan O, Arac S, Tuncay C. Practice of tourniquet use in Turkey: a pilot study. Acta Orthop Traumatol Turc. 2016;50(2):162-70. doi: 10.3944/AOTT.2015.15.0066.
Background: PubMed 31524296Ding L, Ding CY, Wang YL, Wang ML, Qian XH, Huang L, Xie XE, Ji HZ. Application effect of pneumatic tourniquet with individualized pressure setting in orthopaedic surgery of extremities: A meta-analysis. J Adv Nurs. 2019 Dec;75(12):3424-3433. doi: 10.1111/jan.14196. Epub 2019 Oct 15.
Background: PubMed 4031590Van Roekel HE, Thurston AJ. Tourniquet pressure: the effect of limb circumference and systolic blood pressure. J Hand Surg Br. 1985 Jun;10(2):142-4. doi: 10.1016/0266-7681(85)90002-6.
Background: PubMed 7894409Pauers RS, Carocci MA. Low pressure pneumatic tourniquets: effectiveness at minimum recommended inflation pressures. J Foot Ankle Surg. 1994 Nov-Dec;33(6):605-9.
Background: PubMed 7130227Shaw JA, Murray DG. The relationship between tourniquet pressure and underlying soft-tissue pressure in the thigh. J Bone Joint Surg Am. 1982 Oct;64(8):1148-52.
Background: PubMed 3972869McLaren AC, Rorabeck CH. The pressure distribution under tourniquets. J Bone Joint Surg Am. 1985 Mar;67(3):433-8.
Background: PubMed 3572594Hargens AR, McClure AG, Skyhar MJ, Lieber RL, Gershuni DH, Akeson WH. Local compression patterns beneath pneumatic tourniquets applied to arms and thighs of human cadavera. J Orthop Res. 1987;5(2):247-52. doi: 10.1002/jor.1100050211.
Background: PubMed 1624856Graham B, Breault MJ, McEwen JA, McGraw RW. Perineural pressures under the pneumatic tourniquet in the upper extremity. J Hand Surg Br. 1992 Jun;17(3):262-6. doi: 10.1016/0266-7681(92)90111-e.
Individual participant dataSharing planned: Undecided

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?

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 7 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 14 Jan 2021. 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 Turkey (Türkiye). 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?

Initial and maximal systolic blood pressure (mmHg) (time frame: Intraoperative). The study lists 4 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 NCT04710225, which also lists 33 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 14 Jan 2021.