Trial Outcomes & Findings for 90° Rotation Technique for LMA FlexibleTM Insertion (NCT NCT03028896)

NCT ID: NCT03028896

Last Updated: 2022-02-09

Results Overview

the first attempt success rate of insertion of LMA FlexibleTM

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 132 participants
• Primary outcome timeframe: at induction
• Results posted on: 2022-02-09

Participant Flow

Participant milestones

Measure	Standard In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.	Rotational After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx. 90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°
Overall Study STARTED	66	66
Overall Study COMPLETED	63	66
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

90° Rotation Technique for LMA FlexibleTM Insertion

Baseline characteristics by cohort

Measure	Standard n=63 Participants In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.	Rotational n=66 Participants After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx. 90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°	Total n=129 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	62 Participants n=5 Participants	62 Participants n=7 Participants	124 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	66 Participants n=7 Participants	129 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: at induction

the first attempt success rate of insertion of LMA FlexibleTM

Outcome measures

Measure	Standard n=63 Participants In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.	Rotational n=66 Participants After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx. 90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°
First Attempt Success Rate	59 Participants	65 Participants

SECONDARY outcome

Timeframe: at induction

time from passed mouth of the device to the effective ventilation after inflation of the cuff

Outcome measures

Measure	Standard n=63 Participants In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.	Rotational n=66 Participants After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx. 90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°
Insertion Time	10.5 seconds Standard Deviation 4.7	9.7 seconds Standard Deviation 4.7

SECONDARY outcome

Timeframe: at induction

audible leak during manual ventilation at mouth

Outcome measures

Measure	Standard n=63 Participants In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.	Rotational n=66 Participants After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx. 90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°
Oropharyngeal Leak Pressure	19.8 cmH2O Standard Deviation 4.9	20.5 cmH2O Standard Deviation 4.2

SECONDARY outcome

Timeframe: post op 1min

Number of Participants with blood staining on the laryngeal mask airway.

Outcome measures

Measure	Standard n=63 Participants In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.	Rotational n=66 Participants After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx. 90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°
Number of Participants With Blood Staining on the Laryngeal Mask Airway	1 Participants	3 Participants

Adverse Events

Standard

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rotational

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

Dr. Bon-wook Koo

SNUBH

Phone: +82-10-7227-1379

Email: tendong2@gmail.com

Results disclosure agreements

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