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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT00803751
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

This study is intended to examine the effectiveness of a new type of laryngoscope, the Truview EVO2, in an infant patient population. They device will be tested against the current clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital in terms of ease of use, view obtained of the vocal cords, and ability to place an endotracheal tube.

Condition or Disease	Intervention/Treatment	Phase
Laryngoscopy	Device: Truview EVO2 laryngoscope; Device: Macintosh laryngoscope	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Truview intubation Receive laryngoscopy with Truview first and is immediately followed by laryngoscopy and intubation with Macintosh	Device: Truview EVO2 laryngoscope; will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope
Active Comparator: Macintosh intubation Macintosh blade will be used first followed by laryngoscopy and intubation with the truview	Device: Macintosh laryngoscope; Intubation using the traditional Macintosh laryngoscope

Outcome Measures

Primary Outcome Measures

1. Quality of Laryngeal View Obtained on Comarck Lehane Classification [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.

2. Number of Intubation Attempts [during intubation prior to surgery]

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

3. Quality of Laryngeal View Obtained With 2nd Laryngoscopy [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.

Secondary Outcome Measures

1. Time Taken for Intubation [throughout the intubation procedure]

2. POGO Score With 1st Laryngoscopy [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.

3. POGO Score With 2nd Laryngoscopy [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age less than one year

2. Requiring general anesthesia and orotracheal intubation

3. Weight less than 10 kg

4. ASA class 1-3

Exclusion Criteria:

1. Documented difficult airway

2. Facial deformities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Hermann Hospital - Texas Medical Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Maria Matuszczak, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Truphatek - Manufacturer's website

Publications

None provided.

• Responsible Party: Maria Matuszczak, Professor - Anesthesiology, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT00803751
• Other Study ID Numbers: Infant Truview
• First Posted: Dec 8, 2008
• Last Update Posted: May 15, 2017
• Last Verified: Mar 1, 2011

• Keywords provided by Maria Matuszczak, Professor - Anesthesiology, The University of Texas Health Science Center, Houston: Laryngoscopy [E04.580.373]

Study Results

Participant Flow

Recruitment Details	The patients were recruited from pediatric day surgery.
Pre-assignment Detail	There were 11 patients excluded from the trial due to incomplete data.

Arm/Group Title	Truview Intubation First Then With Macintosh	Macintosh Intubation First Followed by Truview Intubation
Arm/Group Description	Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade	Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
Period Title: Overall Study
STARTED	26	23
COMPLETED	26	23
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Truview Intubation First Then With Macintosh	Macintosh Intubation First Followed by Truview Intubation	Total
Arm/Group Description	Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade	Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope	Total of all reporting groups
Overall Participants	26	23	49
Age (Count of Participants)
<=18 years	26 100%	23 100%	49 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	6.35 (3.1)	6.42 (3.2)	6.39 (3.13)
Sex: Female, Male (Count of Participants)
Female	19 73.1%	12 52.2%	31 63.3%
Male	7 26.9%	11 47.8%	18 36.7%
Region of Enrollment (participants) [Number]
United States	26 100%	23 100%	49 100%

Outcome Measures

1. Primary Outcome

Title	Quality of Laryngeal View Obtained on Comarck Lehane Classification
Description	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.
Time Frame	during laryngoscopy prior to intubation. Few minutes before intubation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Truview	Mac Blade
Arm/Group Description	This group has data for all the truview intubations	This groups has data with all the mac blade intubations
Measure Participants	26	23
1	21 80.8%	13 56.5%
2a	3 11.5%	5 21.7%
2b	1 3.8%	4 17.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Truview, Mac Blade
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	Fisher Exact
	Comments

2. Primary Outcome

Title	Number of Intubation Attempts
Description	Number of participants with the indicated number of intubation attempts (1/2/3)
Time Frame	during intubation prior to surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Truview	Mac Blade
Arm/Group Description	This group has data for all the truview intubations	This groups has data with all the mac blade intubations
Measure Participants	26	23
1	17 65.4%	23 100%
2	4 15.4%	2 8.7%
3	2 7.7%	1 4.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Truview, Mac Blade
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Time Taken for Intubation
Time Frame	throughout the intubation procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Truview	Mac Blade
Arm/Group Description	This group has data for all the truview intubations	This groups has data with all the mac blade intubations
Measure Participants	26	23
Mean (Standard Deviation) [seconds]	25.23 (11.09)	28.33 (12.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Truview, Mac Blade
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.36
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	POGO Score With 1st Laryngoscopy
Description	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.
Time Frame	Before patient is intubated (few minutes before intubation)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Truview	Mac Blade
Arm/Group Description	This group has data for all the truview intubations	This groups has data with all the mac blade intubations
Measure Participants	26	23
Mean (Standard Deviation) [Score]	93.65 (15.72)	73.81 (23.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Truview, Mac Blade
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	t-test, 2 sided
	Comments

5. Primary Outcome

Title	Quality of Laryngeal View Obtained With 2nd Laryngoscopy
Description	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.
Time Frame	during laryngoscopy prior to intubation (few minutes prior to intubation)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Truview	Mac Blade
Arm/Group Description	This group has data for all the truview intubations	This groups has data with all the mac blade intubations
Measure Participants	26	23
1	10 38.5%	21 91.3%
2a	7 26.9%	2 8.7%
2b	9 34.6%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Truview, Mac Blade
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

6. Secondary Outcome

Title	POGO Score With 2nd Laryngoscopy
Description	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.
Time Frame	Before patient is intubated

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Truview	Mac Blade
Arm/Group Description	This group has data for all the truview intubations	This groups has data with all the mac blade intubations
Measure Participants	26	23
Mean (Standard Deviation) [Score]	74.3 (25.1)	98.0 (8.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Truview, Mac Blade
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Truview Intubation First Then With Macintosh		Macintosh Intubation First Followed by Truview Intubation
Arm/Group Description	Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade		Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
All Cause Mortality
	Truview Intubation First Then With Macintosh		Macintosh Intubation First Followed by Truview Intubation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Truview Intubation First Then With Macintosh		Macintosh Intubation First Followed by Truview Intubation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Truview Intubation First Then With Macintosh		Macintosh Intubation First Followed by Truview Intubation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.