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Recruiting NCT04498598

Structural Modification In Supraglottic Airway Device

No phase Interventional Airway Complication of Anesthesia Ventilation Therapy; Complications Hypoxia Hypoventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A/Z Supraglottic airway.
Who it may be relevant to
Registry conditions: Airway Complication of Anesthesia, Ventilation Therapy; Complications, Hypoxia, Hypoventilation. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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

Primary outcome measures

  • Test effect of A/Z modification of supraglottic airway device on rate of successful oxygenation and ventilation before beginning a full clinical trial [Time frame: During and immediately after the intervention]
Secondary outcome measures (2)
  • Rate of successful exchange from supraglottic to endotracheal ventilation using A/Z modified SGA [Time frame: During and immediately after intervention]
  • Rate of successful exchange from endotracheal to supraglottic ventilation using A/Z modified SGA [Time frame: During and immediately after intervention]

Eligibility criteria

Inclusion criteria

  • Adult patients
  • scheduled for a general anesthesia procedure with ETT \& muscle relaxation

Exclusion criteria

  • Patients who are not able to consent
  • Non English Speaking
  • History of difficult airway
  • Physical exam of airway which suggests difficulty in airway management or need to use special equipment
  • BMI >35
  • Gastroesophageal reflux disease
  • Anesthetic plan other than general anesthesia
  • Emergency procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Cleveland Clinic Foundation — Cleveland

Identifiers

NCT: NCT04498598 · 20-163

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗