Structural Modification In Supraglottic Airway Device

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Hypoventilation; Hypoxia; Airway Complication of Anesthesia; Ventilation Therapy; Complications

Treatments: Device: A/Z Supraglottic airway

Study type: Interventional

Funder types: Other

Identifiers

NCT04498598

20-163

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

A/Z Airway

Experimental group

Description:

Patients under general anesthesia for surgical procedures who need airway management for ventilation.

Treatment:

Device: A/Z Supraglottic airway