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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04498598
Other study ID # 20-163
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2020
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source The Cleveland Clinic
Contact Rafi Avitsian, MD
Phone 216-444-9735
Email avitsir@ccf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed A/Z modification of a supraglottic airway (SGA) incorporates an opening in the SGA body that enables access to the endotracheal tube (ETT) through the body of the SGA without the need of using an exchange catheter, thus enabling an ETT to move in the body of the SGA and convert a supraglottic to endotracheal ventilation. In its original form an adaptor made from same material currently used in the endotracheal tubes can make ventilation through the proposed airway device possible in exactly the same manner of a conventional SGA currently used. This adapter also known as the R-piece can be replaced with an ETT. The modification also allows placement of SGA over an existing ETT to convert and endotracheal (ET) to supraglottic (SG) mode of ventilation without the need to use an exchange catheter.


Description:

The special design allows conversion of a telescopic coaxial portion (R piece), replacing with an ETT which can act coaxially to provide both supraglottic (up position) and endotracheal (down position) of ETT. See this modification in https://www.youtube.com/watch?v=iy84lALU1aI Currently the proposed change to the conventional SGA has been made and feasibility tested on Manikins. The A/Z airway modification is also demonstrated in the attached link video https://www.youtube.com/watch?v=ukLOAC55iG8 In this study, we are trialing the A/Z concept on an original A/Z modification by a manufacturer on their currently used SGA. Thus instead of investigators making the changes by cutting a channel in a conventional SGA immediately before use in the Operating Room, they have asked a manufacturer to do so professionally.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 1. Adult patients 2. scheduled for a general anesthesia procedure with ETT & muscle relaxation Exclusion Criteria: 1. Patients who are not able to consent 2. Non English Speaking 3. History of difficult airway 4. Physical exam of airway which suggests difficulty in airway management or need to use special equipment 5. BMI >35 6. Gastroesophageal reflux disease 7. Anesthetic plan other than general anesthesia 8. Emergency procedures

Study Design


Related Conditions & MeSH terms


Intervention

Device:
A/Z Supraglottic airway
Patient receive supraglottic airway for general anesthesia which can be converted to endotracheal ventilation reversibly

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test effect of A/Z modification of supraglottic airway device on rate of successful oxygenation and ventilation before beginning a full clinical trial An alteration and structural modification in the supraglottic airway device can improve safety of airway exchange in patient needing general anesthesia, this proof of concept should show if the modification has any affect on oxygenation and ventilation. During and immediately after the intervention
Secondary Rate of successful exchange from supraglottic to endotracheal ventilation using A/Z modified SGA Evaluate if a modification of configuration on "Laryngeal Mask Airway" improves safety during Supraglottic to Endotracheal conversion without using an exchange catheter During and immediately after intervention
Secondary Rate of successful exchange from endotracheal to supraglottic ventilation using A/Z modified SGA Evaluate if this modification can enhance smooth extubation after endotracheal intubation by converting an endotracheal tube to a supraglottic airway During and immediately after intervention
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