Clinical trial NCT04498598: Structural Modification In Supraglottic Airway Device
Official title: Structural Modification In Supraglottic Airway Device Enhances Exchange Between Supraglottic & Endotracheal Ventilation Modes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Airway Complication of Anesthesia
Ventilation Therapy; Complications
Hypoxia
Hypoventilation
Keywords: Airway Management
Oxygenation and Ventilation
Airway Devices
Supraglottic Airway
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test effect of A/Z modification of supraglottic airway device on rate of successful oxygenation and ventilation before beginning a full clinical trial
timeFrame: During and immediately after the intervention
Secondary outcomes:
measure: Rate of successful exchange from supraglottic to endotracheal ventilation using A/Z modified SGA
timeFrame: During and immediately after intervention
measure: Rate of successful exchange from endotracheal to supraglottic ventilation using A/Z modified SGA
timeFrame: During and immediately after intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References: