N/A
N=264
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.
Laryngoscopy
Bottom Line
View on ClinicalTrials.gov: NCT06149338 ↗Enrolled (actual)
264
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Rate of Successful Intubation With One Attempt — 132; 119 Participants — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Macintosh laryngoscope (Device); Vie Scope (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Andrew's General Hospital, Patras, Greece
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Successful Intubation With One Attempt |
132; 119 | 0.0002 sig |
| PRIMARY Mean Intubation Time |
8.08; 16.65 | < 0.0001 sig |
| SECONDARY Rate of Successful Intubation |
132; 124 | 0.0041 sig |
| SECONDARY Visualization of the Glottis, According to Cormack Lehane Classification |
100; 102; 20; 21; 12; 9 | 0.7895 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06149338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.