Minimal Inflation Tourniquet Pressure Using Induced Hypotension

NCT ID: NCT04055779

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2019-11-30

Brief 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. 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

Conditions

Vascular Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

estimation method for arterial occlusion pressure

Intervention Type: OTHER

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 pressure

Intervention Type: OTHER

: 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

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

estimation method for arterial occlusion pressure

Intervention Type: OTHER

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 pressure

Intervention Type: OTHER

: 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

Interventions

estimation method for arterial occlusion pressure

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).

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • ASA physical status I and II.

• Male and female patient
• Age group 20-50 years old

Exclusion Criteria

• • 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Samaa Rashwan

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samaa ak Rashwan, MD

Role: PRINCIPAL_INVESTIGATOR

Assisstant proffesor of anesthesia

Locations

Beni-Suef University Hospital

Banī Suwayf, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Samaa ak Rashwan, MD

Role: CONTACT

samakassemrashwan@gmail.com

020120159125

Facility Contacts

Samaa Rashwan, MD

Role: primary

0201270159125

Other Identifiers

Beni-Suef University Hospital

Identifier Type: -

Identifier Source: org_study_id