Trial Outcomes & Findings for Pentax Airway Scope (AWS) Intubation (NCT NCT00667693)

NCT ID: NCT00667693

Last Updated: 2018-07-24

Results Overview

time between sufficient muscle relaxant and placement of intubation tube

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds
• Results posted on: 2018-07-24

Participant Flow

Participant milestones

Measure	Macintosh Intubation with a Macintosh laryngoscope Macintosh intubation: Macintosh intubation	Pentax intubation with a the Pentax AWS Pentax AWS: Intubation with Pentax AWS
Overall Study STARTED	49	52
Overall Study COMPLETED	49	50
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pentax Airway Scope (AWS) Intubation

Baseline characteristics by cohort

Measure	Macintosh n=49 Participants Intubation with a Macintosh laryngoscope Macintosh intubation: Macintosh intubation	Pentax n=50 Participants intubation with a the Pentax AWS Pentax AWS: Intubation with Pentax AWS	Total n=99 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 14 • n=5 Participants	50 years STANDARD_DEVIATION 12 • n=7 Participants	49 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	50 participants n=7 Participants	99 participants n=5 Participants
ASA status II: mild systemic disease	7 participants n=5 Participants	15 participants n=7 Participants	22 participants n=5 Participants
ASA status III: severe systemic disease	40 participants n=5 Participants	32 participants n=7 Participants	72 participants n=5 Participants
ASA status IV: severe systemic disease that threats to life	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Mallampati score 1: Soft palate, uvula, fauces, pillars visible	14 participants n=5 Participants	21 participants n=7 Participants	35 participants n=5 Participants
Mallampati score 2: Soft palate, uvula, fauces visible	21 participants n=5 Participants	18 participants n=7 Participants	39 participants n=5 Participants
Mallampati score 3: Soft palate, base of uvula visible	13 participants n=5 Participants	7 participants n=7 Participants	20 participants n=5 Participants
Mallampati score 4: Only hard palate visible	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds

time between sufficient muscle relaxant and placement of intubation tube

Outcome measures

Measure	Macintosh n=49 Participants Intubation with a Macintosh laryngoscope Macintosh intubation: Macintosh intubation	Pentax n=50 Participants intubation with a the Pentax AWS Pentax AWS: Intubation with Pentax AWS
Time to Intubation	26 seconds Interval 22.0 to 29.0	38 seconds Interval 31.0 to 50.0

SECONDARY outcome

Timeframe: From the start of intubation until 24 hours after surgery

Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation

Outcome measures

Measure	Macintosh n=49 Participants Intubation with a Macintosh laryngoscope Macintosh intubation: Macintosh intubation	Pentax n=50 Participants intubation with a the Pentax AWS Pentax AWS: Intubation with Pentax AWS
Ease of Intubation	40 units on a scale Standard Deviation 28	52 units on a scale Standard Deviation 31

SECONDARY outcome

Timeframe: From the start of intubation until 24 hours after surgery

The count number of successful intubation on the first attempt

Outcome measures

Measure	Macintosh n=49 Participants Intubation with a Macintosh laryngoscope Macintosh intubation: Macintosh intubation	Pentax n=50 Participants intubation with a the Pentax AWS Pentax AWS: Intubation with Pentax AWS
Successful Intubation on the First Attempt	45 Participants	43 Participants

SECONDARY outcome

Timeframe: From the start of intubation until 24 hours after surgery

We summarized the number of patients with one, two or three intubation attempts.

Outcome measures

Measure	Macintosh n=49 Participants Intubation with a Macintosh laryngoscope Macintosh intubation: Macintosh intubation	Pentax n=50 Participants intubation with a the Pentax AWS Pentax AWS: Intubation with Pentax AWS
The Number of Patients With Different Number of Intubation Attempts one attempt	45 Participants	44 Participants
The Number of Patients With Different Number of Intubation Attempts two attempts	4 Participants	3 Participants
The Number of Patients With Different Number of Intubation Attempts three attempts	0 Participants	3 Participants

SECONDARY outcome

Timeframe: From the start of intubation until 24 hours after surgery

Outcome measures

Measure	Macintosh n=49 Participants Intubation with a Macintosh laryngoscope Macintosh intubation: Macintosh intubation	Pentax n=50 Participants intubation with a the Pentax AWS Pentax AWS: Intubation with Pentax AWS
The Number of Patients With Bleeding	0 Participants	2 Participants

Adverse Events

Macintosh

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pentax

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

Daniel I Sessler, MD

Cleveland Clinic Foundation

Phone: 216-445-8396

Email: sesslerd@ccf.org

Results disclosure agreements

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