Structural Modification In Supraglottic Airway Device

Hypoxia Clinical Trial

Official title:

Structural Modification In Supraglottic Airway Device Enhances Exchange Between Supraglottic & Endotracheal Ventilation Modes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04498598
• Other study ID #: 20-163
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Airway Complication of Anesthesia
• Hypoventilation
• Hypoxia
• Ventilation Therapy; Complications

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

External Links

•   Conference Abstracts