Intubation Complications
Conditions
Brief summary
The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system during the course of mechanical ventilation and intubation of critical care patients in Intensive Care Unit.
Interventions
DEVICEAnapnoGuard 100 System
AnapnoGuard™ 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.
Sponsors
Hospitech Respiration
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age above 21 (men and women); * Patient is admitted to ICU and expected to receive mechanical ventilation for more than 12 hours * Absence of clear signs of pneumonia and lung contusion on chest X ray; * For study patients, connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation; * No fever or fever from a known non chest/lung origin;
Exclusion criteria
* Patients who had been treated with mechanical ventilation during the last 3 months; * Patients with facial, oropharyngeal or neck trauma * BMI \> 40 * Pregnant women * Patients ventilated in prone position * Difficult intubation (defined as more than 3 intubation attempts)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of AE (adverse events) and SAE (serious adverse events) | participants will be followed for the entire duration of intubation (an expected average of 8 days) |
Countries
Italy
Outcome results
None listed