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Modified Supraglottic Airway Device for Ventilation Therapy Complications
N/A
Recruiting
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during and immediately after intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a new supraglottic airway device that has an opening that allows access to the endotracheal tube. This could potentially simplify conversion from supraglottic to endotracheal ventilation.
Who is the study for?
This trial is for adult patients who are scheduled for a general anesthesia procedure that requires an endotracheal tube and muscle relaxation. It's not suitable for individuals with a BMI over 35, acid reflux issues, plans other than general anesthesia, communication barriers like non-English speaking, history of difficult airway management or those needing emergency procedures.
What is being tested?
The trial is testing a modified supraglottic airway device designed to improve ventilation by allowing direct access to the trachea without additional equipment. This could make it easier to switch between supraglottic and endotracheal ventilation during surgery.
What are the potential side effects?
Potential side effects may include discomfort in the throat, difficulty breathing if the device doesn't work properly, swelling or injury inside the throat due to insertion of the device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during and immediately after the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during and immediately after the intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Test effect of A/Z modification of supraglottic airway device on rate of successful oxygenation and ventilation before beginning a full clinical trial
Secondary study objectives
Rate of successful exchange from endotracheal to supraglottic ventilation using A/Z modified SGA
Rate of successful exchange from supraglottic to endotracheal ventilation using A/Z modified SGA
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: A/Z AirwayExperimental Treatment1 Intervention
Patients under general anesthesia for surgical procedures who need airway management for ventilation.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,372 Total Patients Enrolled
3 Trials studying Hypoxia
764 Patients Enrolled for Hypoxia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is over 35.My surgery will not use general anesthesia.I have had problems with my airway in the past.I have acid reflux.I have not undergone any emergency medical procedures recently.I am unable to give consent by myself.My physical exam showed I might have trouble breathing without special equipment.I am an adult scheduled for surgery with general anesthesia and muscle relaxation.
Research Study Groups:
This trial has the following groups:- Group 1: A/Z Airway
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.