Trial Outcomes & Findings for Glottic View Using Supraglottic Devices in Pediatric Patients (NCT NCT02532465)

NCT ID: NCT02532465

Last Updated: 2019-08-22

Results Overview

Grade I view - Glottic aperture seen completely without any obstruction, Grade II view - Glottic aperture seen only partially but visual obstruction is less than 50%.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 15 seconds after insertion of Air-Q or i-gel
• Results posted on: 2019-08-22

Participant Flow

Participant milestones

Measure	Air-Q The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. Air-Q	I-gel The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. i-gel
Overall Study STARTED	25	25
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Air-Q The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. Air-Q	I-gel The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. i-gel
Overall Study Protocol Violation	1	0
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Air-Q n=25 Participants The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. Air-Q	I-gel n=25 Participants The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. i-gel	Total n=50 Participants Total of all reporting groups
Age, Continuous	14 years n=25 Participants	12 years n=25 Participants	13 years n=50 Participants
Sex: Female, Male Female	13 Participants n=25 Participants	15 Participants n=25 Participants	28 Participants n=50 Participants
Sex: Female, Male Male	12 Participants n=25 Participants	10 Participants n=25 Participants	22 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 participants n=25 Participants	25 participants n=25 Participants	50 participants n=50 Participants
Weight	50 kilograms n=25 Participants	49 kilograms n=25 Participants	49 kilograms n=50 Participants

PRIMARY outcome

Timeframe: 15 seconds after insertion of Air-Q or i-gel

Grade I view - Glottic aperture seen completely without any obstruction, Grade II view - Glottic aperture seen only partially but visual obstruction is less than 50%.

Outcome measures

Measure	Air-Q n=24 Participants The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. Air-Q	I-gel n=24 Participants The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. i-gel
Acceptable View of the Glottic Aperature (Grade I-II)	20 participants	21 participants

SECONDARY outcome

Timeframe: Immediately after anesthesia induction

Amount of time it takes to insert airway.

Outcome measures

Measure	Air-Q n=24 Participants The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. Air-Q	I-gel n=24 Participants The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. i-gel
Airway Insertion Time	19 seconds Interval 16.0 to 20.0	21 seconds Interval 16.0 to 29.0

SECONDARY outcome

Timeframe: 15 seconds after insertion of Air-Q or i-gel

After confirmation of adequate placement and ventilation, a flexible fiberoptic bronchoscope was inserted through the stem of the supraglottic device to visualize the glottic aperture. The time taken for bronchoscopy, defined as time from disconnection of the anesthetic circuit from the SGA to first visualization of the glottic aperture, was recorded.

Outcome measures

Measure	Air-Q n=24 Participants The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. Air-Q	I-gel n=24 Participants The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. i-gel
Time to Achieve Best Fiberoptic View	25 seconds Interval 20.0 to 30.0	21 seconds Interval 17.0 to 40.0

Adverse Events

Air-Q

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

I-gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senthil Krishna, MD

Nationwide Children's Hospital

Phone: 614-722-4200

Email: Senthil.Krishna@nationwidechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place