Trial Outcomes & Findings for AuraOnce Performance Observation (NCT NCT04128527)

NCT ID: NCT04128527

Last Updated: 2021-11-03

Results Overview

Is leakage observed (yes/no) if yes, insert signs of leakage

• Recruitment status: COMPLETED
• Target enrollment: 16 participants
• Primary outcome timeframe: During procedure, less than 1 hour
• Results posted on: 2021-11-03

Participant Flow

Participant milestones

Measure	Adults, Laryngeal Mask Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AuraOnce Performance Observation

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: During procedure, less than 1 hour

Is leakage observed (yes/no) if yes, insert signs of leakage

Outcome measures

Measure	Adults, Laryngeal Mask n=16 Participants Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
Number of Participants With Leakage Observed During Procedure	0 Participants

SECONDARY outcome

Timeframe: During procedure, less than 1 hour

Investigator evaluation of ease of insertion on a 5-point scale (very difficult (=1) to very easy (=5))

Outcome measures

Measure	Adults, Laryngeal Mask n=16 Participants Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
Investigator Evaluation of Ease of Insertion on a 5-point Scale (Very Difficult (=1) to Very Easy (=5))	4.6 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: During procedure, less than 1 hour

Investigator evaluation of ease of obtaining seal on a 5-point scale (very difficult (=1) to very easy (=5))

Outcome measures

Measure	Adults, Laryngeal Mask n=16 Participants Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
Investigator Evaluation of Ease of Obtaining Seal on a 5-point Scale (Very Difficult (=1) to Very Easy (=5))	4.7 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: During procedure, less than 1 hour

Investigator evaluation of overall performance on a 5-point scale (very bad (=1) to excellent (=5))

Outcome measures

Measure	Adults, Laryngeal Mask n=16 Participants Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
Investigator Evaluation of Overall Performance on a 5-point Scale (Very Bad (=1) to Excellent (=5))	4.6 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: During procedure, less than 1 hour

It is checked if the mask is placed above the vocal cords (yes/no)

Outcome measures

Measure	Adults, Laryngeal Mask n=16 Participants Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
Number of Participants With Correct Placement of Mask	16 Participants

SECONDARY outcome

Timeframe: During procedure, less than one hour

After insertion of the mask, it is assessed by bronchoscopy whether the tip of the mask is folded. Folded tip= Yes, Not folded= No

Outcome measures

Measure	Adults, Laryngeal Mask n=16 Participants Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
Number of Participants Where Tip of the Mask is Folded	0 Participants

Adverse Events

Adults, Laryngeal Mask

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

Signe Toräng

Ambu

Phone: 31267089

Email: sito@ambu.com

Results disclosure agreements

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

Restriction type: LTE60