Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients being intubated using Macintosh laryngoscope | Experimental |
| |
| Patients being intubated using Vie Scope laryngoscope | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macintosh laryngoscope | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Evaluation immediately after the first attempt of intubation |
| 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 | Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouth |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Successful Intubation | This outcome depends on whether the intubation of each patient will be successful or not | Evaluation immediately after the intubation attempts |
| Visualization of the Glottis, According to Cormack Lehane Classification |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Andrew's General Hospital of Patras | Pátrai | 263 32 | Greece |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Vie Scope | Device | 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. |
|
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.
| This outcome will be evaluated during laryngoscopy and intubation of each patient |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | 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 | Posted | Count of Participants | Participants | Evaluation immediately after the first attempt of intubation |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Mean | Standard Deviation | seconds | Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouth |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Successful Intubation | This outcome depends on whether the intubation of each patient will be successful or not | Posted | Count of Participants | Participants | Evaluation immediately after the intubation attempts |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | This outcome will be evaluated during laryngoscopy and intubation of each patient |
|
During the intubation process (< 60 sec), the patient was simultaneously assessed for complications like injury of the structures of the upper airway, caused by the manipulations of the airway operator for the airway establishment. After the successful endotracheal intubation, the patients were not reassessed for any complications.
Not provided
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 | 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. | 0 | 132 | 0 | 132 | 0 | 132 |
| EG001 | 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. | 0 | 132 | 0 | 132 | 0 | 132 |
Not provided
Not provided
The airway operator was an anesthesiologist trainee with minimum experience. Thereby, the outcomes are not indicative of the Macintosh and Vie Scope use by consultants. Moreover, patients in both groups were not reassessed after endotracheal intubation, by direct laryngoscopy, in order to detect any potential complications. Finally, the current study was focused on the easy airway management of adults, providing no data about difficult airway management in adults and pediatric patients.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vasileios Boviatsis | Saint Andrew's General Hospital of Patras | +306982925945 | billboviatsis@gmail.com |
| Jan 24, 2025 |
| Prot_SAP_001.pdf |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|