Trial Outcomes & Findings for Effect of Modified Stylet Angulation on the Intubation With GlideScope® (NCT NCT02547064)

NCT ID: NCT02547064

Last Updated: 2017-06-09

Results Overview

Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (\>30 mmHg)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 162 participants
• Primary outcome timeframe: Intraoperative intubation
• Results posted on: 2017-06-09

Participant Flow

Participant milestones

Measure	90 Degree The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Overall Study STARTED	81	81
Overall Study COMPLETED	78	79
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Modified Stylet Angulation on the Intubation With GlideScope®

Baseline characteristics by cohort

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®	Total n=157 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=5 Participants	79 Participants n=7 Participants	157 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 13 • n=5 Participants	57 years STANDARD_DEVIATION 16 • n=7 Participants	58 years STANDARD_DEVIATION 14 • n=5 Participants
Sex/Gender, Customized Female	37 participants n=5 Participants	33 participants n=7 Participants	70 participants n=5 Participants
Sex/Gender, Customized Male	41 participants n=5 Participants	46 participants n=7 Participants	87 participants n=5 Participants
Region of Enrollment Korea, Republic of	78 participants n=5 Participants	79 participants n=7 Participants	157 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative intubation

Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (>30 mmHg)

Outcome measures

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Time to Intubation	47.2 sec Standard Deviation 35.8	31.0 sec Standard Deviation 17.5

SECONDARY outcome

Timeframe: Intraoperative intubation

The number of patients in which the intubation was successful at the first time.

Outcome measures

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Success Rate of Intubation	68 Participants	79 Participants

SECONDARY outcome

Timeframe: Intraoperative intubation

Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult).

Outcome measures

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Difficulty of Intubation Measured Using Visual Analogue Scale	35 units on a scale Standard Deviation 29	22 units on a scale Standard Deviation 24

SECONDARY outcome

Timeframe: Intraoperative intubation

External laryngeal manipulation is defined as the compression of neck for the facilitation of laryngeal view. Number of participants for whom external laryngeal manipulation was necessary will be measured.

Outcome measures

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Number of Participants for Whom External Laryngeal Manipulation Was Necessary	14 Participants	3 Participants

SECONDARY outcome

Timeframe: Intraoperative intubation

The grade of Cormack-Lehan was assessed as I/II/III/IV (I: Full view of glottis, II: Partial view of glottis, III: Only epiglottis seen, none of glottis seen, IV: Neither glottis nor epiglottis seen). Grade I was considered better outcomes.

Outcome measures

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Cormack-Lehan Grade I	70 Participants	68 Participants
Cormack-Lehan Grade II	7 Participants	9 Participants
Cormack-Lehan Grade III	1 Participants	2 Participants
Cormack-Lehan Grade IV	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Intraoperative anesthetic induction

The Mallapati grade was assessed as I/II/III/IV (I: Soft palate, uvula, fauces, pillars visible, II: Soft palate, uvula, fauces visible, III: Soft palate, base of uvula visible, IV: Only hard palate visible). Grade I was considered better outcomes.

Outcome measures

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Mallampati Grade IV	7 Participants	6 Participants
Mallampati Grade I	36 Participants	32 Participants
Mallampati Grade II	25 Participants	33 Participants
Mallampati Grade III	10 Participants	8 Participants

SECONDARY outcome

Timeframe: Intraoperative anesthetic induction

The thyromental distance was measured.

Outcome measures

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Thyromental Distance	79.1 mm Standard Deviation 23.6	78.5 mm Standard Deviation 24.5

SECONDARY outcome

Timeframe: at 1, 24 hr postoperatively

Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable)

Outcome measures

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Postoperative Sore Throat Measured Using Visual Analogue Scale 1 h postoperatively	16 units on a scale Standard Deviation 27	13 units on a scale Standard Deviation 25
Postoperative Sore Throat Measured Using Visual Analogue Scale 24 h postoperatively	10 units on a scale Standard Deviation 20	8 units on a scale Standard Deviation 18

SECONDARY outcome

Timeframe: Intraoperative intubation

Mean blood pressure is measured before and 2 min after intubation.

Outcome measures

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Mean Blood Pressure Before intubation	77 mmHg Standard Deviation 12	78 mmHg Standard Deviation 14
Mean Blood Pressure 2 min after intubation	105 mmHg Standard Deviation 22	108 mmHg Standard Deviation 25

SECONDARY outcome

Timeframe: Intraoperative intubation

Heart rates are measured before and 2 min after intubation.

Outcome measures

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Heart Rate Before intubation	73 beats per minute Standard Deviation 15	73 beats per minute Standard Deviation 17
Heart Rate 2 min after intubation	93 beats per minute Standard Deviation 19	93 beats per minute Standard Deviation 16

SECONDARY outcome

Timeframe: Intraoperative intubation

Larynx injury is assessed.

Outcome measures

Measure	90 Degree n=78 Participants The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Glidescope guided intubation GlideScope®	70 Degree n=79 Participants The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Glidescope guided intubation GlideScope®
Airway Injury	5 Participants	0 Participants

Adverse Events

90 Degree

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

70 Degree

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

Hyun-Chang Kim

Keimyung university

Phone: +821028862876

Email: onidori1979@gmail.com

Results disclosure agreements

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