NCT01550978CompletedNot Applicable
The Safety of Using the AnapnoGuard 100 System in Intubated Critical Care Patients
Hospitech Respiration1 site in 1 country60 target enrollmentStarted: February 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Rate of AE (adverse events) and SAE (serious adverse events)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
Rate of AE (adverse events) and SAE (serious adverse events)
Time Frame: participants will be followed for the entire duration of intubation (an expected average of 8 days)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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