Intubation
Conditions
Keywords
supine emergency intubations, emergency intubations
Brief summary
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
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.
Interventions
DEVICEAirway Scope
Tracheal intubation by Airway Scope
DEVICEMacintosh Laryngoscope
Tracheal intubation by Macintosh Laryngoscope
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Time | The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Intubation Success Rate | Intubation period | — |
| Number of Intubation Attempts | Intubation period | — |
| Incidence of Intubation Complications | Intubation period | Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2\<95%) and Esophageal intubation |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Airway Scope Intubation with Airway Scope
Airway Scope: Tracheal intubation by Airway Scope | 50 |
| Macintosh Laryngoscope Intubation with Macintosh laryngoscope
Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Airway Scope | Macintosh Laryngoscope | Total |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 19 | 53 years STANDARD_DEVIATION 18 | 55 years STANDARD_DEVIATION 20 |
| Height | 158 cm STANDARD_DEVIATION 9 | 162 cm STANDARD_DEVIATION 9 | 160 cm STANDARD_DEVIATION 10 |
| Mouth opening | 4.6 cm STANDARD_DEVIATION 0.7 | 4.7 cm STANDARD_DEVIATION 0.7 | 4.7 cm STANDARD_DEVIATION 0.7 |
| Sex: Female, Male Female | 30 Participants | 22 Participants | 52 Participants |
| Sex: Female, Male Male | 20 Participants | 28 Participants | 48 Participants |
| Weight | 56 kg STANDARD_DEVIATION 10 | 58 kg STANDARD_DEVIATION 10 | 57 kg STANDARD_DEVIATION 10 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography.
Population: Patients with number of intubation attempt no more than 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Airway Scope | Intubation Time | 18 seconds | Standard Deviation 4 |
| Macintosh Laryngoscope | Intubation Time | 35 seconds | Standard Deviation 16 |
Secondary
Incidence of Intubation Complications
Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2\<95%) and Esophageal intubation
Time frame: Intubation period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Airway Scope | Incidence of Intubation Complications | Muscosal trauma | 2 cases |
| Airway Scope | Incidence of Intubation Complications | Hypoxia | 0 cases |
| Airway Scope | Incidence of Intubation Complications | Lip injury | 4 cases |
| Airway Scope | Incidence of Intubation Complications | Esophageal intubation | 0 cases |
| Airway Scope | Incidence of Intubation Complications | Dental injury | 0 cases |
| Macintosh Laryngoscope | Incidence of Intubation Complications | Esophageal intubation | 1 cases |
| Macintosh Laryngoscope | Incidence of Intubation Complications | Dental injury | 1 cases |
| Macintosh Laryngoscope | Incidence of Intubation Complications | Muscosal trauma | 5 cases |
| Macintosh Laryngoscope | Incidence of Intubation Complications | Lip injury | 6 cases |
| Macintosh Laryngoscope | Incidence of Intubation Complications | Hypoxia | 0 cases |
Secondary
Number of Intubation Attempts
Time frame: Intubation period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Airway Scope | Number of Intubation Attempts | 1 | 37 times |
| Airway Scope | Number of Intubation Attempts | 2 | 10 times |
| Airway Scope | Number of Intubation Attempts | 3 | 3 times |
| Macintosh Laryngoscope | Number of Intubation Attempts | 1 | 45 times |
| Macintosh Laryngoscope | Number of Intubation Attempts | 2 | 5 times |
| Macintosh Laryngoscope | Number of Intubation Attempts | 3 | 0 times |
Secondary
Overall Intubation Success Rate
Time frame: Intubation period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Airway Scope | Overall Intubation Success Rate | 98 Percentage of overall intubation |
| Macintosh Laryngoscope | Overall Intubation Success Rate | 100 Percentage of overall intubation |