NCT04128527

AuraOnce Performance Observation

Completed Results posted Last updated 3 November 2021

What this trial tests

trial testing Placement of laryngeal mask in Anesthesia in 16 participants. Completed in 5 November 2019.

Timeline

9 October 2019

Primary endpoint
5 November 2019

5 November 2019

Quick facts

Lead sponsor	Ambu A/S
Status	Completed
Study type	OBSERVATIONAL
Enrollment	16
Start date	9 October 2019
Primary completion	5 November 2019
Estimated completion	5 November 2019
Sites	1 location across Denmark

Drugs / interventions tested

• Placement of laryngeal mask

Conditions studied

• Anesthesia — all drugs for Anesthesia →

Sponsor

Ambu A/S — full company profile →

Who can join

18 and older, any sex, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Leakage Observed During Procedure Primary · During procedure, less than 1 hour

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

Group	Value	95% CI
Adults, Laryngeal Mask	0

Investigator Evaluation of Ease of Insertion on a 5-point Scale (Very Difficult (=1) to Very Easy (=5)) Secondary · During procedure, less than 1 hour

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

Group	Value	95% CI
Adults, Laryngeal Mask	4.6	± 0.7

Investigator Evaluation of Ease of Obtaining Seal on a 5-point Scale (Very Difficult (=1) to Very Easy (=5)) Secondary · 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))

Group	Value	95% CI
Adults, Laryngeal Mask	4.7	± 0.6

Investigator Evaluation of Overall Performance on a 5-point Scale (Very Bad (=1) to Excellent (=5)) Secondary · During procedure, less than 1 hour

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

Group	Value	95% CI
Adults, Laryngeal Mask	4.6	± 0.5

Number of Participants With Correct Placement of Mask Secondary · During procedure, less than 1 hour

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

Group	Value	95% CI
Adults, Laryngeal Mask	16

Number of Participants Where Tip of the Mask is Folded Secondary · 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

Group	Value	95% CI
Adults, Laryngeal Mask	0

Sponsor's own description

This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark.

The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019.

The intention is to perform a quality assessment of the AuraOnce. Subjects will not be asked to participate in this study as it is a quality study where the AuraOnce is used within its intended use and according to normal clinical procedure.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.