Laryngoscopy
Conditions
Keywords
Laryngoscopy [E04.580.373]
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.
Interventions
will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope
DEVICEMacintosh laryngoscope
Intubation using the traditional Macintosh laryngoscope
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Intubation Attempts | during intubation prior to surgery | Number of participants with the indicated number of intubation attempts (1/2/3) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time Taken for Intubation | throughout the intubation procedure | — |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
The patients were recruited from pediatric day surgery.
Pre-assignment details
There were 11 patients excluded from the trial due to incomplete data.
Participants by arm
| Arm | Count |
|---|---|
| Truview Intubation First Then With Macintosh Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade | 26 |
| Macintosh Intubation First Followed by Truview Intubation Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope | 23 |
| Total | 49 |
Baseline characteristics
| Characteristic | Macintosh Intubation First Followed by Truview Intubation | Truview Intubation First Then With Macintosh | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 26 Participants | 49 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.42 months STANDARD_DEVIATION 3.2 | 6.35 months STANDARD_DEVIATION 3.1 | 6.39 months STANDARD_DEVIATION 3.13 |
| Region of Enrollment United States | 23 participants | 26 participants | 49 participants |
| Sex: Female, Male Female | 12 Participants | 19 Participants | 31 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 23 |
| serious Total, serious adverse events | 0 / 26 | 0 / 23 |
Outcome results
Primary
Number of Intubation Attempts
Number of participants with the indicated number of intubation attempts (1/2/3)
Time frame: during intubation prior to surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Truview | Number of Intubation Attempts | 1 | 17 Participants |
| Truview | Number of Intubation Attempts | 2 | 4 Participants |
| Truview | Number of Intubation Attempts | 3 | 2 Participants |
| Mac Blade | Number of Intubation Attempts | 1 | 23 Participants |
| Mac Blade | Number of Intubation Attempts | 2 | 2 Participants |
| Mac Blade | Number of Intubation Attempts | 3 | 1 Participants |
p-value: 0.45Fisher Exact
Primary
Quality of Laryngeal View Obtained on Comarck Lehane Classification
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Truview | Quality of Laryngeal View Obtained on Comarck Lehane Classification | 1 | 21 Participants |
| Truview | Quality of Laryngeal View Obtained on Comarck Lehane Classification | 2a | 3 Participants |
| Truview | Quality of Laryngeal View Obtained on Comarck Lehane Classification | 2b | 1 Participants |
| Mac Blade | Quality of Laryngeal View Obtained on Comarck Lehane Classification | 2b | 4 Participants |
| Mac Blade | Quality of Laryngeal View Obtained on Comarck Lehane Classification | 1 | 13 Participants |
| Mac Blade | Quality of Laryngeal View Obtained on Comarck Lehane Classification | 2a | 5 Participants |
p-value: 0.17Fisher Exact
Primary
Quality of Laryngeal View Obtained With 2nd Laryngoscopy
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Truview | Quality of Laryngeal View Obtained With 2nd Laryngoscopy | 1 | 10 Participants |
| Truview | Quality of Laryngeal View Obtained With 2nd Laryngoscopy | 2a | 7 Participants |
| Truview | Quality of Laryngeal View Obtained With 2nd Laryngoscopy | 2b | 9 Participants |
| Mac Blade | Quality of Laryngeal View Obtained With 2nd Laryngoscopy | 2b | 0 Participants |
| Mac Blade | Quality of Laryngeal View Obtained With 2nd Laryngoscopy | 1 | 21 Participants |
| Mac Blade | Quality of Laryngeal View Obtained With 2nd Laryngoscopy | 2a | 2 Participants |
p-value: <0.001Fisher Exact
Secondary
POGO Score With 1st Laryngoscopy
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Truview | POGO Score With 1st Laryngoscopy | 93.65 Score | Standard Deviation 15.72 |
| Mac Blade | POGO Score With 1st Laryngoscopy | 73.81 Score | Standard Deviation 23.34 |
p-value: 0.002t-test, 2 sided
Secondary
POGO Score With 2nd Laryngoscopy
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Truview | POGO Score With 2nd Laryngoscopy | 74.3 Score | Standard Deviation 25.1 |
| Mac Blade | POGO Score With 2nd Laryngoscopy | 98.0 Score | Standard Deviation 8.94 |
p-value: 0.0004t-test, 2 sided
Secondary
Time Taken for Intubation
Time frame: throughout the intubation procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Truview | Time Taken for Intubation | 25.23 seconds | Standard Deviation 11.09 |
| Mac Blade | Time Taken for Intubation | 28.33 seconds | Standard Deviation 12.67 |
p-value: 0.36t-test, 2 sided