Structural Modification In Supraglottic Airway Device

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT04498598
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 30, 2020
Status verified
May 2026
Primary completion
Aug 24, 2026
Completion
Aug 24, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: A/Z Airway
    Patients under general anesthesia for surgical procedures who need airway management for ventilation.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195
Rafi Avitsian, MD
[email protected]
216-444-9735

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By research site
Cleveland Clinic Foundation· Cleveland, OH

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