Airway Complication of Anesthesia, Hypoventilation, Hypoxia, Ventilation Therapy; Complications
Conditions
Keywords
Airway Management, Oxygenation and Ventilation, Airway Devices, Supraglottic Airway
Brief 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.
Detailed 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.
Interventions
DEVICEA/Z Supraglottic airway
Patient receive supraglottic airway for general anesthesia which can be converted to endotracheal ventilation reversibly
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test effect of A/Z modification of supraglottic airway device on rate of successful oxygenation and ventilation before beginning a full clinical trial | During and immediately after the intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful exchange from supraglottic to endotracheal ventilation using A/Z modified SGA | During and immediately after intervention | Evaluate if a modification of configuration on "Laryngeal Mask Airway" improves safety during Supraglottic to Endotracheal conversion without using an exchange catheter |
| Rate of successful exchange from endotracheal to supraglottic ventilation using A/Z modified SGA | During and immediately after intervention | Evaluate if this modification can enhance smooth extubation after endotracheal intubation by converting an endotracheal tube to a supraglottic airway |
Countries
United States
Contacts
CONTACTRafi Avitsian, MD
CONTACTMark Mettler
Outcome results
None listed