Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System
Not Applicable
Completed
- Conditions
- Intubation Complications
- Interventions
- Device: AnapnoGuard 100 System
- Registration Number
- NCT01550978
- Lead Sponsor
- Hospitech Respiration
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Group AnapnoGuard 100 System Patients intubated with AnapnoGuard EndoTracheal Tube and connected to the AnapnoGuard 100 Control System
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Policlinico Universitario A. Gemelli
š®š¹Rome, Italy