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.
- Conditions
- Laryngoscopy
- Interventions
- Device: Macintosh laryngoscopeDevice: Vie Scope
- Registration Number
- NCT06149338
- Lead Sponsor
- St. Andrew's General Hospital, Patras, Greece
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 264
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients being intubated using Macintosh laryngoscope Macintosh laryngoscope - Patients being intubated using Vie Scope laryngoscope Vie Scope -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Saint Andrew's General Hospital of Patras
🇬🇷Patra, Greece