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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Truview intubation | Experimental | Receive laryngoscopy with Truview first and is immediately followed by laryngoscopy and intubation with Macintosh |
|
| Macintosh intubation | Active Comparator | Macintosh blade will be used first followed by laryngoscopy and intubation with the truview |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Truview EVO2 laryngoscope | Device | will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during laryngoscopy prior to intubation. Few minutes before intubation |
| Number of Intubation Attempts | Number of participants with the indicated number of intubation attempts (1/2/3) | during intubation prior to surgery |
| 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. | during laryngoscopy prior to intubation (few minutes prior to intubation) |
| Measure | Description | Time Frame |
|---|---|---|
| Time Taken for Intubation | throughout the intubation procedure | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Matuszczak, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital - Texas Medical Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| Truphatek - Manufacturer's website | View source |
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There were 11 patients excluded from the trial due to incomplete data.
The patients were recruited from pediatric day surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Truview Intubation First Then With Macintosh | Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade |
| FG001 | Macintosh Intubation First Followed by Truview Intubation | Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Truview Intubation First Then With Macintosh | Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade |
| BG001 | Macintosh Intubation First Followed by Truview Intubation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Participants | during laryngoscopy prior to intubation. Few minutes before intubation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Truview Intubation First Then With Macintosh | Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Matuszczak | UT Medical School, Houston | 713-498-2768 | maria.matuszczak@uth.tmc.edu |
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| Macintosh laryngoscope | Device | Intubation using the traditional Macintosh laryngoscope |
|
| Before patient is intubated (few minutes before intubation) |
| 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. | Before patient is intubated |
Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Number of Intubation Attempts | Number of participants with the indicated number of intubation attempts (1/2/3) | Posted | Number | Participants | during intubation prior to surgery |
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| Secondary | Time Taken for Intubation | Posted | Mean | Standard Deviation | seconds | throughout the intubation procedure |
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| 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. | Posted | Mean | Standard Deviation | Score | Before patient is intubated (few minutes before intubation) |
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| 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. | Posted | Number | Participants | during laryngoscopy prior to intubation (few minutes prior to intubation) |
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| 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. | Posted | Mean | Standard Deviation | Score | Before patient is intubated |
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| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Macintosh Intubation First Followed by Truview Intubation | Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope | 0 | 23 | 0 | 23 |
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| 3 |
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| 2b |
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