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Procedure
SafeLM as a supraglottic airway device with video capability for Anesthesia
N/A
Recruiting
Led By Lauren M Nakazawa, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of intubation
Awards & highlights
Study Summary
This trial looks at using a new device to help intubate patients during medical procedures.
Who is the study for?
This trial is for adults needing general anesthesia and airway management during elective surgery. Candidates should not be pregnant, have a BMI over 40, known difficult airways, significant respiratory issues like severe sleep apnea or COPD, history of upper airway surgery, or major risk of aspiration.Check my eligibility
What is being tested?
The study tests the SafeLM device's effectiveness as both an airway tool and a guide for intubation with/without video assistance. It explores if SafeLM can help doctors see better when placing breathing tubes in patients under anesthesia.See study design
What are the potential side effects?
Potential side effects may include discomfort in the throat, difficulty swallowing post-operation due to the device placement, and rare risks associated with any intubation such as minor bleeding or injury to teeth or tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of intubation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of intubation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intubation success rate
Secondary outcome measures
Number of insertion attempts required to achieve effective oxygenation and ventilation
Safety of the SafeLM as a conduit for intubation
Safety of the SafeLM as an SGA
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: SafeLM as a supraglottic airway device without video capabilityExperimental Treatment1 Intervention
Group II: SafeLM as a supraglottic airway device with video capabilityExperimental Treatment1 Intervention
Group III: SafeLM as a conduit for intubation using an endotracheal tube with video capabilityExperimental Treatment1 Intervention
Group IV: SafeLM as a conduit for intubation using a bougie with video capabilityExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,917 Total Patients Enrolled
Lauren M Nakazawa, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have a breathing tube inserted through your mouth.You have a medical condition that prevents the use of certain muscle-relaxing medications.You have had surgery on your throat or upper airway in the past.You have a body mass index (BMI) higher than 40, which means you are severely overweight.You have a known or suspected problem with managing your breathing during the study.You have a known or suspected respiratory condition like severe sleep apnea or chronic obstructive pulmonary disease (COPD).You have a history of severe heartburn or acid reflux.
Research Study Groups:
This trial has the following groups:- Group 1: SafeLM as a supraglottic airway device with video capability
- Group 2: SafeLM as a supraglottic airway device without video capability
- Group 3: SafeLM as a conduit for intubation using an endotracheal tube with video capability
- Group 4: SafeLM as a conduit for intubation using a bougie with video capability
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is registration for this experiment still open?
"This clinical trial, posted on September 1st 2023 and most recently edited on August 9th 2023, is not actively recruiting patients. However, 131 other medical studies are in the process of seeking participants at this moment."
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