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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03899116
Recruitment Status : Unknown
Verified July 2019 by Yasmin Hassab elnaby, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Yasmin Hassab elnaby, Cairo University

Study Description
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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

Condition or disease Intervention/treatment
Tourniquet 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 Design
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Study Type : Observational
Estimated Enrollment : 81 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients :Randomized Control Study
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. mean arterial blood pressure [ Time Frame: 15 minutes after start of deflation of cuff ]
    The lowest mean arterial blood pressure during a 15-minute period after starting deflation of the tourniquet.


Secondary Outcome Measures :
  1. hypotension [ Time Frame: 15 minutes after start of deflation of cuff ]
    incidence of post tourniquet hypotension

  2. cardiac output [ Time Frame: 15 minutes after start of deflation of cuff ]
    cardiac output after starting deflation using non invasive electrical cardiometry


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients above 50 years scheduled for orthopedic lower limb surgery under pneumatic tourniquet
Criteria

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) ).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899116


Contacts
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Contact: yasmin ibrahim 01006719987 yalnaby@yahoo.com

Locations
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Egypt
Cairo university
Cairo, Egypt, 115711
Contact: yasmin ibrahim    1006719987    yalnaby@yahoo.com   
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Yasmin Hassab elnaby, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03899116    
Other Study ID Numbers: 101-2018
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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