Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study was designed to determine the first attempt success rate of tracheal intubation with the McGRATH™ MAC laryngoscope using direct visualization in patients with known difficult airways, as well as exploring the possibility of identifying a particular direct Cormack-Lehane (C-L) grade view where indirect (video) visualization can be most beneficial during laryngoscopy and intubation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| McGrath Mac intubations | Experimental | All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The liquid crystal display (LCD) monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| McGrath MAC enhanced direct laryngoscope | Device | The McGRATH® MAC enhanced direct laryngoscope (EDL) combines the familiarity of direct laryngoscopy with an inline video camera for an enhanced view. All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View | All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist. | after successful endotracheal tube placement |
| Measure | Description | Time Frame |
|---|---|---|
| Glottic View With Direct Laryngoscopy | Glottic view as described by Cormack and Lehane, scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible | at the time of laryngoscopy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carin A Hagberg, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| Device information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | McGrath Mac Intubations | All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The liquid crystal display (LCD) monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | McGrath Mac Intubations | All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is reported not for 100 subjects, but only for the 94 who were analyzed. Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties. |
| 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 | Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View | All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist. | Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties. | Posted | Count of Participants | Participants | after successful endotracheal tube placement |
Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients enter the PACU within 30 minutes of completion of surgery, and they leave the PACU approximately 1-2 hours after entering the PACU.
All 100 patients were assessed for SAEs. 94 patients were assessed for other AEs (not including SAEs): 6 patients were excluded from data analysis; 4 patients were found to not meet inclusion criteria; one patient with glottic view grade 3 was erroneously intubated via the indirect method; and for another patient, the anesthesiologist aborted the protocol due to encountered difficulties.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | McGrath Mac Intubations | All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hoarseness | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carin A. Hagberg, MD | The University of Texas Health Science Center at Houston | 713-500-6200 | Carin.A.Hagberg@uth.tmc.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Glottic View With Indirect Laryngoscopy | Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible | at the time of laryngoscopy |
| Time for Direct View Laryngoscopy During the First Attempt | Time from mouth opening to best direct laryngoscopic view | at the time of laryngoscopy |
| Time for Indirect View Laryngoscopy During the First Attempt | Time from mouth opening to best indirect laryngoscopic view | at the time of laryngoscopy |
| Time for Intubation | Time for laryngoscopy (either direct or indirect) plus the time for endotracheal tube (ETT) cuff to pass vocal cords. | at the time of laryngoscopy |
| Number of Intubation Attempts | at the time of intubation |
| Number of Participants Who Received External Laryngeal Manipulation During the First Attempt | at the time of intubation |
| Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt | at the time of intubation |
| Subjective Ease of Laryngoscopy | The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as "very easy," "easy," "slight resistance," "difficult," or "not possible." The difficulty of laryngoscopy was evaluated during the insertion and placement of the McGRATH™ MAC, from the patient's lips, into their oropharynx, until a glottic view was obtained. | at the time of laryngoscopy |
| Subjective Ease of Intubation | The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as "very easy," "easy," "slight resistance," "difficult," or "not possible." The difficulty of endotracheal tube (ETT) delivery (that is, intubation) was evaluated during the insertion of the ETT into the patient's mouth, until the ETT passed the vocal cords. | at the time of laryngoscopy |
Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties. |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | McGrath Mac Intubations | All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist. |
|
|
| Secondary | Glottic View With Direct Laryngoscopy | Glottic view as described by Cormack and Lehane, scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible | Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties. | Posted | Count of Participants | Participants | at the time of laryngoscopy |
|
|
|
| Secondary | Glottic View With Indirect Laryngoscopy | Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible | Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties. | Posted | Count of Participants | Participants | at the time of laryngoscopy |
|
|
|
| Secondary | Time for Direct View Laryngoscopy During the First Attempt | Time from mouth opening to best direct laryngoscopic view | Of the 100 patients recruited, 6 patients were excluded from data analysis, as describe in Outcome Measure 1's Analysis Population Description. 78 of the 94 analyzed had direct laryngoscopy, and thus 78 are analyzed in this outcome measure. | Posted | Mean | Standard Deviation | seconds | at the time of laryngoscopy |
|
|
|
| Secondary | Time for Indirect View Laryngoscopy During the First Attempt | Time from mouth opening to best indirect laryngoscopic view | Of the 100 patients recruited, 6 patients were excluded from data analysis, as describe in Outcome Measure 1's Analysis Population Description. 16 of the 94 analyzed had direct laryngoscopy, and thus 16 are analyzed in this outcome measure. | Posted | Mean | Standard Deviation | seconds | at the time of laryngoscopy |
|
|
|
| Secondary | Time for Intubation | Time for laryngoscopy (either direct or indirect) plus the time for endotracheal tube (ETT) cuff to pass vocal cords. | Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties. | Posted | Mean | Standard Deviation | seconds | at the time of laryngoscopy |
|
|
|
| Secondary | Number of Intubation Attempts | Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties. | Posted | Count of Participants | Participants | at the time of intubation |
|
|
|
| Secondary | Number of Participants Who Received External Laryngeal Manipulation During the First Attempt | Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties. | Posted | Count of Participants | Participants | at the time of intubation |
|
|
|
| Secondary | Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt | Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties. | Posted | Count of Participants | Participants | at the time of intubation |
|
|
|
| Secondary | Subjective Ease of Laryngoscopy | The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as "very easy," "easy," "slight resistance," "difficult," or "not possible." The difficulty of laryngoscopy was evaluated during the insertion and placement of the McGRATH™ MAC, from the patient's lips, into their oropharynx, until a glottic view was obtained. | Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties. | Posted | Count of Participants | Participants | at the time of laryngoscopy |
|
|
|
| Secondary | Subjective Ease of Intubation | The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as "very easy," "easy," "slight resistance," "difficult," or "not possible." The difficulty of endotracheal tube (ETT) delivery (that is, intubation) was evaluated during the insertion of the ETT into the patient's mouth, until the ETT passed the vocal cords. | Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties. | Posted | Count of Participants | Participants | at the time of laryngoscopy |
|
|
|
| 0 |
| 100 |
| 48 |
| 94 |
| Sore mouth | General disorders | Systematic Assessment |
|
| sore neck | General disorders | Systematic Assessment |
|
| Sore jaw | General disorders | Systematic Assessment |
|
| Dysphonia | General disorders | Systematic Assessment |
|
| Dysphagia | General disorders | Systematic Assessment |
|
| Alteration in Tongue | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Grade 3 view |
|
| Grade 4 view |
|
| Grade 3 view |
|
| Grade 4 view |
|
| difficult |
|
| not possible |
|
| difficult |
|
| not possible |
|