Structural Modification In Supraglottic Airway Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients
scheduled for a general anesthesia procedure with ETT & muscle relaxation
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
A/Z Supraglottic airway
DevicePatient receive supraglottic airway for general anesthesia which can be converted to endotracheal ventilation reversibly
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: A/Z AirwayExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Test effect of A/Z modification of supraglottic airway device on rate of successful oxygenation and ventilation before beginning a full clinical trial
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.
Time frame
During and immediately after the interventionSecondary outcomes
1
Rate of successful exchange from supraglottic to endotracheal ventilation using A/Z modified SGA
Evaluate if a modification of configuration on "Laryngeal Mask Airway" improves safety during Supraglottic to Endotracheal conversion without using an exchange catheter
Time frame
During and immediately after intervention2
Rate of successful exchange from endotracheal to supraglottic ventilation using A/Z modified SGA
Evaluate if this modification can enhance smooth extubation after endotracheal intubation by converting an endotracheal tube to a supraglottic airway
Time frame
During and immediately after interventionSponsors and contacts
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Source ClinicalTrials.gov