Laryngoscopy
Conditions
Keywords
Vie Scope, Macintosh, Rate of successful intubation, Intubation time
Brief summary
The rate of successful intubation and the required time for intubation, using Vie Scope and Macintosh Laryngoscope will be compared, in order to evaluate the efficacy of Vie Scope in comparison with Macintosh in expected easy airways. Hence, a prospective randomized controlled single-blind superiority clinical trial will be conducted. Inclusion criteria: patients of both sexes, positive or negative rapid test for COVID-19 or possible contamination, age ≥18 years old, BMI: 18.5 - 30 kg/m2, visualization of the glottis grade 1 or 2, according to Cormack-Lehane Classification. Exclusion criteria: age under 18 years old, BMI under 18.5 kg/m2 and BMI over 30 kg/m2, visualization of the glottis grade 3 - 4, according to Cormack-Lehane Classification. The laryngoscopy and intubation of the patients will be attempted by the same person-resident of Anesthesiology, under the supervision of experienced Anesthesiologist consultants.
Interventions
DEVICEMacintosh laryngoscope
Macintosh laryngoscope has been the gold standard for endotracheal intubation since the middle of 20th century. During laryngoscopy and direct vision of the vocal cords, an endotracheal tube is passed into the trachea, establishing the airway.
DEVICEVie Scope
Vie Scope is a laryngoscope, whose function is relied on Seldinger technique. Firstly, bougie is passed through the translucent barrel of Vie Scope under direct vision between the vocal cords and into the trachea. Then, Vie Scope is removed and an endotracheal tube is passed over the bougie, which will be finally removed. The inflation of the endotracheal tube's cuff is followed by ventilation and confirmation of the tube placement.
Sponsors
St. Andrew's General Hospital, Patras, Greece
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients of both sexes * Positive or negative rapid test for COVID-19 or possible contamination * Age ≥18 years old * BMI: 18.5 - 30 kg/m2 * Visualization of the glottis grade 1 or 2, according to Cormack-Lehane Classification.
Exclusion criteria
* Age under 18 years old * BMI under 18.5 kg/m2 and BMI over 30 kg/m2 * Visualization of the glottis grade 3 - 4, according to Cormack-Lehane Classification.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Successful Intubation With One Attempt | Evaluation immediately after the first attempt of intubation | This outcome depends on whether the intubation of each patient will be successful or not, after the first attempt of intubation |
| Mean Intubation Time | Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouth | Mean time interval required for intubation, which is determined from the time of the insertion of the laryngoscope into the patient's mouth until the time of the inflation of the tube's cuff on each patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Successful Intubation | Evaluation immediately after the intubation attempts | This outcome depends on whether the intubation of each patient will be successful or not |
| Visualization of the Glottis, According to Cormack Lehane Classification | This outcome will be evaluated during laryngoscopy and intubation of each patient | Ability to visualize the glottis, according to Cormack Lehane classification. The specific classification is divided into four grades (1-4). The higher the grade, the higher the likelihood of difficult intubation. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Being Intubated Using Macintosh Laryngoscope Macintosh laryngoscope: Macintosh laryngoscope has been the gold standard for endotracheal intubation since the middle of 20th century. During laryngoscopy and direct vision of the vocal cords, an endotracheal tube is passed into the trachea, establishing the airway. | 132 |
| Patients Being Intubated Using Vie Scope Laryngoscope Vie Scope: Vie Scope is a laryngoscope, whose function is relied on Seldinger technique. Firstly, bougie is passed through the translucent barrel of Vie Scope under direct vision between the vocal cords and into the trachea. Then, Vie Scope is removed and an endotracheal tube is passed over the bougie, which will be finally removed. The inflation of the endotracheal tube's cuff is followed by ventilation and confirmation of the tube placement. | 132 |
| Total | 264 |
Baseline characteristics
| Characteristic | Patients Being Intubated Using Macintosh Laryngoscope | Total | Patients Being Intubated Using Vie Scope Laryngoscope |
|---|---|---|---|
| Age, Continuous | 63.5 years | 65 years | 67 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 132 Participants | 264 Participants | 132 Participants |
| Region of Enrollment Greece | 132 participants | 264 participants | 132 participants |
| Sex: Female, Male Female | 68 Participants | 130 Participants | 62 Participants |
| Sex: Female, Male Male | 64 Participants | 134 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 132 | 0 / 132 |
| other Total, other adverse events | 0 / 132 | 0 / 132 |
| serious Total, serious adverse events | 0 / 132 | 0 / 132 |
Outcome results
Primary
Mean Intubation Time
Mean time interval required for intubation, which is determined from the time of the insertion of the laryngoscope into the patient's mouth until the time of the inflation of the tube's cuff on each patient
Time frame: Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Being Intubated Using Macintosh Laryngoscope | Mean Intubation Time | 8.08 seconds | Standard Deviation 5.34 |
| Patients Being Intubated Using Vie Scope Laryngoscope | Mean Intubation Time | 16.65 seconds | Standard Deviation 5.02 |
p-value: <0.0001Kruskal-Wallis
Primary
Rate of Successful Intubation With One Attempt
This outcome depends on whether the intubation of each patient will be successful or not, after the first attempt of intubation
Time frame: Evaluation immediately after the first attempt of intubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Being Intubated Using Macintosh Laryngoscope | Rate of Successful Intubation With One Attempt | 132 Participants |
| Patients Being Intubated Using Vie Scope Laryngoscope | Rate of Successful Intubation With One Attempt | 119 Participants |
p-value: 0.0002Chi-squared
p-value: <0.05Fisher Exact
Secondary
Rate of Successful Intubation
This outcome depends on whether the intubation of each patient will be successful or not
Time frame: Evaluation immediately after the intubation attempts
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Being Intubated Using Macintosh Laryngoscope | Rate of Successful Intubation | 132 Participants |
| Patients Being Intubated Using Vie Scope Laryngoscope | Rate of Successful Intubation | 124 Participants |
p-value: 0.0041Chi-squared
p-value: <0.05Fisher Exact
Secondary
Visualization of the Glottis, According to Cormack Lehane Classification
Ability to visualize the glottis, according to Cormack Lehane classification. The specific classification is divided into four grades (1-4). The higher the grade, the higher the likelihood of difficult intubation.
Time frame: This outcome will be evaluated during laryngoscopy and intubation of each patient
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Being Intubated Using Macintosh Laryngoscope | Visualization of the Glottis, According to Cormack Lehane Classification | Grade 1 | 100 Participants |
| Patients Being Intubated Using Macintosh Laryngoscope | Visualization of the Glottis, According to Cormack Lehane Classification | Grade 2a | 20 Participants |
| Patients Being Intubated Using Macintosh Laryngoscope | Visualization of the Glottis, According to Cormack Lehane Classification | Grade 2b | 12 Participants |
| Patients Being Intubated Using Vie Scope Laryngoscope | Visualization of the Glottis, According to Cormack Lehane Classification | Grade 1 | 102 Participants |
| Patients Being Intubated Using Vie Scope Laryngoscope | Visualization of the Glottis, According to Cormack Lehane Classification | Grade 2a | 21 Participants |
| Patients Being Intubated Using Vie Scope Laryngoscope | Visualization of the Glottis, According to Cormack Lehane Classification | Grade 2b | 9 Participants |
p-value: 0.7895Kruskal-Wallis