Trial Outcomes & Findings for 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. (NCT NCT06149338)
NCT ID: NCT06149338
Last Updated: 2025-02-07
Results Overview
This outcome depends on whether the intubation of each patient will be successful or not, after the first attempt of intubation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
264 participants
Primary outcome timeframe
Evaluation immediately after the first attempt of intubation
Results posted on
2025-02-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
132
|
|
Overall Study
COMPLETED
|
132
|
132
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Patients Being Intubated Using Macintosh Laryngoscope
n=132 Participants
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.
|
Patients Being Intubated Using Vie Scope Laryngoscope
n=132 Participants
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.
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
67 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
132 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
132 participants
n=5 Participants
|
132 participants
n=7 Participants
|
264 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluation immediately after the first attempt of intubationThis outcome depends on whether the intubation of each patient will be successful or not, after the first attempt of intubation
Outcome measures
| Measure |
Patients Being Intubated Using Macintosh Laryngoscope
n=132 Participants
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.
|
Patients Being Intubated Using Vie Scope Laryngoscope
n=132 Participants
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.
|
|---|---|---|
|
Rate of Successful Intubation With One Attempt
|
132 Participants
|
119 Participants
|
PRIMARY outcome
Timeframe: Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouthMean 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
Outcome measures
| Measure |
Patients Being Intubated Using Macintosh Laryngoscope
n=132 Participants
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.
|
Patients Being Intubated Using Vie Scope Laryngoscope
n=132 Participants
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.
|
|---|---|---|
|
Mean Intubation Time
|
8.08 seconds
Standard Deviation 5.34
|
16.65 seconds
Standard Deviation 5.02
|
SECONDARY outcome
Timeframe: Evaluation immediately after the intubation attemptsThis outcome depends on whether the intubation of each patient will be successful or not
Outcome measures
| Measure |
Patients Being Intubated Using Macintosh Laryngoscope
n=132 Participants
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.
|
Patients Being Intubated Using Vie Scope Laryngoscope
n=132 Participants
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.
|
|---|---|---|
|
Rate of Successful Intubation
|
132 Participants
|
124 Participants
|
SECONDARY outcome
Timeframe: This outcome will be evaluated during laryngoscopy and intubation of each patientAbility 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.
Outcome measures
| Measure |
Patients Being Intubated Using Macintosh Laryngoscope
n=132 Participants
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.
|
Patients Being Intubated Using Vie Scope Laryngoscope
n=132 Participants
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.
|
|---|---|---|
|
Visualization of the Glottis, According to Cormack Lehane Classification
Grade 1
|
100 Participants
|
102 Participants
|
|
Visualization of the Glottis, According to Cormack Lehane Classification
Grade 2a
|
20 Participants
|
21 Participants
|
|
Visualization of the Glottis, According to Cormack Lehane Classification
Grade 2b
|
12 Participants
|
9 Participants
|
Adverse Events
Patients Being Intubated Using Macintosh Laryngoscope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Being Intubated Using Vie Scope Laryngoscope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Vasileios Boviatsis
Saint Andrew's General Hospital of Patras
Phone: +306982925945
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place