Lower Extremity Elevation to Minimize Hemodynamic Instability During Induction of General Anesthesia
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to determine if lower extremity elevation (LEE) will reduce the incidence of postinduction hypotension, to compare the utilization of vasoactive medications after induction in patients with LEE and patients without LEE and to determine if LEE will increase measured cardiac output
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2024
CompletedFirst Posted
Study publicly available on registry
July 22, 2024
CompletedStudy Start
First participant enrolled
August 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2025
CompletedFebruary 24, 2026
February 1, 2026
11 months
July 9, 2024
February 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants that demonstrate hypotension
Hypotension is defined as the reduction in mean arterial pressure by 20% or greater comparing the blood pressure measured before induction of anesthesia
From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Secondary Outcomes (5)
Number of participants that demonstrate Nadir blood pressure
From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Change in heart rate
From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Number of participants that need rescue vasoactive agents
From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Accumulated dose of rescue vasoactive agents
End of study (within 15 minutes of baseline)
Change in non-invasive cardiac output
From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Study Arms (2)
Group 1: LEE
EXPERIMENTALGroup 2: no LEE
NO INTERVENTIONInterventions
Patients will be in supine position during induction with a 12" wedge placed at the level of the Achilles tendon (LEE)
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists (ASA)3 or lower
- Patients requiring general anesthesia
You may not qualify if:
- Allergic reaction to drugs commonly used for general anesthesia including fentanyl, midazolam, propofol, ephedrine and phenylephrine
- Pregnant women
- Requiring rapid sequence induction
- Prisoners
- Patient refusal
- Emergency Surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ranganathan Govindaraj, MD
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 9, 2024
First Posted
July 22, 2024
Study Start
August 12, 2024
Primary Completion
June 27, 2025
Study Completion
June 27, 2025
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share