Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients
1 other identifier
observational
81
1 country
1
Brief Summary
Deflation of the pneumatic tourniquet used in lower limb surgery is usually associated with hemodynamic instability, metabolic and respiratory changes. These changes are usually tolerated by young, healthy patients; However, these complications are risky for elderly and cardiac patients. The aim of this study is to assess the effect of gradual deflation of thigh tourniquet on the hemodynamics and arterial blood gases compared to the usual practice
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJuly 25, 2019
July 1, 2019
5 months
March 6, 2019
July 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
mean arterial blood pressure
The lowest mean arterial blood pressure during a 15-minute period after starting deflation of the tourniquet.
15 minutes after start of deflation of cuff
Secondary Outcomes (2)
hypotension
15 minutes after start of deflation of cuff
cardiac output
15 minutes after start of deflation of cuff
Study Arms (3)
G50
The tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation.
G100
The tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation.
G0
The tourniquet cuff will be released till complete deflation.
Interventions
Eligibility Criteria
patients above 50 years scheduled for orthopedic lower limb surgery under pneumatic tourniquet
You may qualify if:
- scheduled for elective orthopedic lower limb surgery under pneumatic tourniquet
You may not qualify if:
- BMI ≥35Kg/ m2
- patients with unstable angina, left ventricular dysfunction , cerebrovascular disease ,bleeding disorders
- contraindication to tourniquet insertion
- patients requiring massive intraoperative blood transfusion (Blood loss more than 50% of the patients' blood volume (70 ml/Kg) ).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo university
Cairo, 115711, Egypt
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 6, 2019
First Posted
April 2, 2019
Study Start
August 1, 2019
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
July 25, 2019
Record last verified: 2019-07