Minimal Inflation Tourniquet Pressure Using Induced Hypotension

NCT04055779 | Unknown

• 1 other identifier: Beni-Suef University Hospital
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (2)

• Tourniquet inflation pressure

  the tourniquet inflation pressure will be determined based on the Arterial occlusion pressure or the limb occlusion pressure

  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.

  one minute before inflation of the tourniquet cuff

Secondary Outcomes (1)

• tourniquet performance

  at the middle and end of surgery

Study Arms (2)

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).

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

Other: estimation method for arterial occlusion pressure; Other: the limb occlusion pressure

Interventions

estimation method for arterial occlusion pressure 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).

Induced hypotension and arterial occlusion pressure; induced hypotension and limb occlusion pressure

the limb occlusion pressure 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 arterial occlusion pressure; induced hypotension and limb occlusion pressure

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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. ,

You may qualify if:

• ASA physical status I and II.
• Male and female patient
• Age group 20-50 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, 6215, Egypt

RECRUITING

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Samaa ak Rashwan, MD

  Assisstant proffesor of anesthesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samaa ak Rashwan, MD

CONTACT

020120159125; samakassemrashwan@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: August 14, 2019
• Study Start: August 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)