N/A
N=79
An Isolation Device to Contain Aerosol During Aerosol Generating Procedures in the Operating Room
Aerosol Containment · Aerosol Generating Procedure
Bottom Line
View on ClinicalTrials.gov: NCT04864236 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Particle Count Measurements During Intubation — 4026; 411; 105; 392 particles/cm^3 — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Novel isolation device to contain aerosol (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- John Shin
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Particle Count Measurements During Intubation |
4026; 411; 105; 392; 74; 185 | <0.001 sig |
| SECONDARY Time to Intubation |
51.6; 41.8 | 0.073 |
| SECONDARY Total Number of Intubation Attempts |
1.05; 1.08 | 0.670 |
| SECONDARY Pre-operative Airway Assessment (Mallampati Score) |
1.74; 1.53 | 0.167 |
| SECONDARY Laryngoscopy Grade View (Cormack-Lehane) Obtained During Intubation |
1.21; 1.10 | 0.198 |
| SECONDARY Pre-operative Airway Assessment (Thyromental Distance) |
3.10; 3.18 | 0.442 |
Summary
The purpose of this study is to test the safety and efficacy of a new isolation device to contain aerosol during aerosol-generating procedures in the operating room.
Eligibility Criteria
Inclusion Criteria
- Elective scheduled surgery (not emergent)
- Planned general anesthesia requiring intubation
Exclusion Criteria
- Patients refusing or unable to consent for any reason, including claustrophobia or inability to cooperate
- Patients predicted to require the use of fiberoptic bronchoscopy for intubation
Data sourced from ClinicalTrials.gov (NCT04864236). 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.