Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients

Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients :Randomized Control Study

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

Study Overview

• Status: Unknown
• Conditions: Tourniquet
• Intervention / Treatment: Other: deflation of pneumatic tourniquet

Detailed Description

Pneumatic tourniquet will be applied on the mid- thigh with cuff pressure of 350 mm Hg. After the end of surgery, the lower limb will be elevated at 45-degree and the patients will randomized into one of the three groups:

G 50 (n=30) : The tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation.

G 100 (n=30): The tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation.

G 0 (n=30): The tourniquet cuff will be released till complete deflation. If hypotension is observed during the procedure, it will be managed by 10 mg ephedrine.

• Study Type: Observational
• Enrollment (Anticipated): 81

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 115711
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients above 50 years scheduled for orthopedic lower limb surgery under pneumatic tourniquet

Description

Inclusion Criteria:

• scheduled for elective orthopedic lower limb surgery under pneumatic tourniquet

Exclusion Criteria:

• 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) ).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
G50; The tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation.	Other: deflation of pneumatic tourniquet; gradual deflation with variable degrees
G100; The tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation.	Other: deflation of pneumatic tourniquet; gradual deflation with variable degrees
G0; The tourniquet cuff will be released till complete deflation.	Other: deflation of pneumatic tourniquet; gradual deflation with variable degrees

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypotension	incidence of post tourniquet hypotension	15 minutes after start of deflation of cuff
cardiac output	cardiac output after starting deflation using non invasive electrical cardiometry	15 minutes after start of deflation of cuff

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 31, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 101-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No