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Pre-hospital intubation is often required in sub-optimal conditions, such as in patients lying on the ground. Direct laryngoscopy and intubation of a patient lying supine on the ground is difficult because the intubator's head is far above the head of the patient. It is thus tricky to align the intubator's visual axis with the patient's tracheal axis. The Airway Scope is a new laryngoscope designed to facilitate intubation without requiring alignment of the oral, pharyngeal, and tracheal axes. We thus tested the hypothesis that the intubation with the Airway Scope is faster than the Macintosh laryngoscope in subjects lying on the ground.
Adult surgical patients were enrolled. Following anesthesia induction and muscle relaxation, direct laryngoscopy was performed as usual and airway characteristics noted. Patients were randomly assigned to tracheal intubation by either the Airway Scope (n=50) or the Macintosh laryngoscope (n=50). Intubation was performed from a table positioned at the height as the operating table, thus simulating intubating on the ground. Overall intubation success rate, time required for intubation, the number of attempts required for successful intubation, and airway complications related to intubation were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Airway Scope | Experimental | Intubation with Airway Scope |
|
| Macintosh laryngoscope | Active Comparator | Intubation with Macintosh laryngoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airway Scope | Device | Tracheal intubation by Airway Scope |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Time | For the case with number of intubation attempt no more than 3, intubation time was defined as the total time of individual intubation attempt. Otherwise, intubation was defined as a failure and excluded from the calculation of intubation time. | The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Intubation Success Rate | Intubation period | |
| Number of Intubation Attempts | Intubation period | |
| Incidence of Intubation Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel I Sessler, MD | The Cleveland Clinic | Study Chair |
| Ryu Komatsu, M.D. | Kosei Hospital, Tokyo, Japan. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosei Hospital,. | Tokyo | 164-8617 | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Airway Scope | Intubation with Airway Scope Airway Scope: Tracheal intubation by Airway Scope |
| FG001 | Macintosh Laryngoscope | Intubation with Macintosh laryngoscope Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Airway Scope | Intubation with Airway Scope Airway Scope: Tracheal intubation by Airway Scope |
| BG001 | Macintosh Laryngoscope | Intubation with Macintosh laryngoscope Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Intubation Time | For the case with number of intubation attempt no more than 3, intubation time was defined as the total time of individual intubation attempt. Otherwise, intubation was defined as a failure and excluded from the calculation of intubation time. | Patients with number of intubation attempt no more than 3 | Posted | Mean | Standard Deviation | seconds | The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography. |
|
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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 | Airway Scope | Intubation with Airway Scope Airway Scope: Tracheal intubation by Airway Scope |
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Patients with anticipated airway difficulties were excluded. All intubations were performed by a single investigator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Sessler | Cleveland Clinic | 216-445-6500 | sessled@ccf.org |
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| Macintosh Laryngoscope |
| Device |
Tracheal intubation by Macintosh Laryngoscope |
|
Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2<95%) and Esophageal intubation |
| Intubation period |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Mouth opening | Mean | Standard Deviation | cm |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
|
|
| Secondary | Overall Intubation Success Rate | Posted | Number | Percentage of overall intubation | Intubation period |
|
|
|
| Secondary | Number of Intubation Attempts | Posted | Number | times | Intubation period |
|
|
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| Secondary | Incidence of Intubation Complications | Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2<95%) and Esophageal intubation | Posted | Number | cases | Intubation period |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Macintosh Laryngoscope | Intubation with Macintosh laryngoscope Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope | 0 | 50 | 0 | 50 |
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| 3 |
|
| Lip injury |
|
| Hypoxia |
|
| Esophageal intubation |
|