A Real-Time Ultrasound Guided Approach For Spinal Anesthesia
Cardiothoracic Anesthesia and Critical Care Patient Registry
1 other identifier
interventional
38
1 country
1
Brief Summary
Our goal was to compare the number of attempts to perform spinal anesthesia using real-time ultrasound guidance versus landmark technique in patients meeting predefined criteria for difficult spinal anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 27, 2012
CompletedFirst Posted
Study publicly available on registry
April 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
July 26, 2019
CompletedJuly 26, 2019
July 1, 2019
4.8 years
March 27, 2012
March 7, 2017
July 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Attempts
Number of attempts (defined as number of needle reinsertions form the skin and NOT number of redirection of the needle) at the beginning of surgery
10-15 minutes before the surgery
Secondary Outcomes (3)
Difficulty of Block Insertion
10-15 minutes before the surgery
Patient Satisfaction
after insert the block but before the surgery
Time to Perform Block (Second)
as measured in seconds after needle insertion, surgical date
Study Arms (2)
ultrasound-guided spinal anesthesia
ACTIVE COMPARATORparticipants will randomly assigned to use ultrasound-guided technique for block placement by Anesthesiologist.
standard spinal anesthesia
PLACEBO COMPARATORrandomized participants will be given standard spinal anesthesia insertion technique for block placement by Anesthesiologist
Interventions
ultrasound-guided technique for block placement
Anesthesiologist will use standard technique for placement of spinal block.
Eligibility Criteria
You may qualify if:
- Patients aged 55 or older
- BMI more than 40
- Scoliosis
- Patients who have undergone previous Spine Surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel Sessler, MD
- Organization
- Cleveland Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Hesham Elsharkawy, M.D.
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2012
First Posted
April 4, 2012
Study Start
March 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
July 26, 2019
Results First Posted
July 26, 2019
Record last verified: 2019-07