Status:
COMPLETED
Evaluating Air Leak Detection in Intubated Patients
Lead Sponsor:
Hospitech Respiration
Conditions:
Critical Care
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial is designed to assess the effectiveness of the AnapnoGaurd 100 system relative to standard of care (SOC) Control, in the course of mechanical ventilation and intubation. The main effectiven...
Eligibility Criteria
Inclusion
- Age above 18 (men and women);
- Subject is expected to receive mechanical ventilation for more than 12 hours;
- Connection of the ETT to the AnapnoGuard system within 12 hours from intubation initiation;
- Subject or subject's legally acceptable representative signed the Informed Consent Form
Exclusion
- 1\. Subjects with facial, oropharyngeal or neck trauma 2. BMI\>40 3. Pregnant women 4. Patient ventilated in prone position 5. Difficult intubation (defined as more than 3 intubation attempts)
- \-
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01857986
Start Date
September 1 2013
End Date
June 1 2015
Last Update
June 19 2017
Active Locations (4)
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1
Mayanei Hayeshua Medical Center, General ICU
Bnei Brak, Israel
2
Rambam Medical Center, Cardiac Surgery Department
Haifa, Israel
3
Rambam Medical Center, Neurosurgery Department
Haifa, Israel
4
Wolfson Medical Center, General ICU
Holon, Israel