Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground

Conditions
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Intubation

Intervention / Treatment
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* Device: Airway Scope
* Device: Macintosh Laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for various surgeries requiring tracheal intubation as part of anesthesia and designated as American Society of Anesthesiologists (ASA) physical status I, II, or III. Exclusion Criteria: Patients with an increased risk of pulmonary aspiration, cervical spine pathology, anticipated airway difficulties (i.e., Mallampati grade IV or thyromental distance <6 cm), and American Society of Anesthesiologists physical status >III.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Airway Scope<br>Intubation with Airway Scope | Device: Airway Scope<br>* Tracheal intubation by Airway Scope<br>|
| Active Comparator: Macintosh laryngoscope<br>Intubation with Macintosh laryngoscope | Device: Macintosh Laryngoscope<br>* Tracheal intubation by Macintosh Laryngoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Intubation Success Rate |  | Intubation period | 
| Number of Intubation Attempts |  | Intubation period | 
| Incidence of Intubation Complications | Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2<95%) and Esophageal intubation | Intubation period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supine emergency intubations, emergency intubations