Trial Outcomes & Findings for A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients (NCT NCT00803751)

Results Overview

The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

during laryngoscopy prior to intubation. Few minutes before intubation

Results posted on

2017-05-15

Participant Flow

The patients were recruited from pediatric day surgery.

There were 11 patients excluded from the trial due to incomplete data.

Participant milestones

Participant milestones
Measure	Truview Intubation First Then With Macintosh Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade	Macintosh Intubation First Followed by Truview Intubation Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
Overall Study STARTED	26	23
Overall Study COMPLETED	26	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Truview Intubation First Then With Macintosh n=26 Participants Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade	Macintosh Intubation First Followed by Truview Intubation n=23 Participants Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	26 Participants n=93 Participants	23 Participants n=4 Participants	49 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	6.35 months STANDARD_DEVIATION 3.1 • n=93 Participants	6.42 months STANDARD_DEVIATION 3.2 • n=4 Participants	6.39 months STANDARD_DEVIATION 3.13 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	12 Participants n=4 Participants	31 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	11 Participants n=4 Participants	18 Participants n=27 Participants
Region of Enrollment United States	26 participants n=93 Participants	23 participants n=4 Participants	49 participants n=27 Participants

PRIMARY outcome

Timeframe: during laryngoscopy prior to intubation. Few minutes before intubation

The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.

Outcome measures

Outcome measures
Measure	Truview n=26 Participants This group has data for all the truview intubations	Mac Blade n=23 Participants This groups has data with all the mac blade intubations
Quality of Laryngeal View Obtained on Comarck Lehane Classification 2b	1 Participants	4 Participants
Quality of Laryngeal View Obtained on Comarck Lehane Classification 2a	3 Participants	5 Participants
Quality of Laryngeal View Obtained on Comarck Lehane Classification 1	21 Participants	13 Participants

PRIMARY outcome

Timeframe: during intubation prior to surgery

Number of participants with the indicated number of intubation attempts (1/2/3)

Outcome measures

Outcome measures
Measure	Truview n=26 Participants This group has data for all the truview intubations	Mac Blade n=23 Participants This groups has data with all the mac blade intubations
Number of Intubation Attempts 1	17 Participants	23 Participants
Number of Intubation Attempts 2	4 Participants	2 Participants
Number of Intubation Attempts 3	2 Participants	1 Participants

PRIMARY outcome

Timeframe: during laryngoscopy prior to intubation (few minutes prior to intubation)

The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.

Outcome measures

Outcome measures
Measure	Truview n=26 Participants This group has data for all the truview intubations	Mac Blade n=23 Participants This groups has data with all the mac blade intubations
Quality of Laryngeal View Obtained With 2nd Laryngoscopy 1	10 Participants	21 Participants
Quality of Laryngeal View Obtained With 2nd Laryngoscopy 2a	7 Participants	2 Participants
Quality of Laryngeal View Obtained With 2nd Laryngoscopy 2b	9 Participants	0 Participants

SECONDARY outcome

Timeframe: throughout the intubation procedure

Outcome measures

Outcome measures
Measure	Truview n=26 Participants This group has data for all the truview intubations	Mac Blade n=23 Participants This groups has data with all the mac blade intubations
Time Taken for Intubation	25.23 seconds Standard Deviation 11.09	28.33 seconds Standard Deviation 12.67

SECONDARY outcome

Timeframe: Before patient is intubated (few minutes before intubation)

POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.

Outcome measures

Outcome measures
Measure	Truview n=26 Participants This group has data for all the truview intubations	Mac Blade n=23 Participants This groups has data with all the mac blade intubations
POGO Score With 1st Laryngoscopy	93.65 Score Standard Deviation 15.72	73.81 Score Standard Deviation 23.34

SECONDARY outcome

Timeframe: Before patient is intubated

POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.

Outcome measures

Outcome measures
Measure	Truview n=26 Participants This group has data for all the truview intubations	Mac Blade n=23 Participants This groups has data with all the mac blade intubations
POGO Score With 2nd Laryngoscopy	74.3 Score Standard Deviation 25.1	98.0 Score Standard Deviation 8.94

Adverse Events

Truview Intubation First Then With Macintosh

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Macintosh Intubation First Followed by Truview Intubation

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

Maria Matuszczak

UT Medical School, Houston

Phone: 713-498-2768

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place