Clinical trial NCT01857986: Evaluating Air Leak Detection in Intubated Patients
Official title: A Study to Evaluate Air Leak Detection Above the Endotracheal Cuff in Intubated Patients Using the AnapnoGuard 100 System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Care
Keywords: Endotracheal intubation
Mechanical ventilation
Critical care
Lead sponsor: Hospitech Respiration
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 effectiveness aspect of this trial is the AnapnoGaurd 100's ability to reduce leaks between the endotracheal tube and the trachea walls as a result of the cuff pressure management. Since the primary outcome can't be measured by any method other than the investigational device, the study groups will be treated as follows:

* The Treatment group in this study will be treated with the fully functional AnapnoGaurd 100 device (per its intended use),
* The Control group will be treated with the AnapnoGuard device, where the cuff control will be disabled (off) and the cuff management will be done according to SOC.

Effectiveness will be measured by the duration and level of carbon dioxide (CO2) leakage around the endotracheal tube (ETT) cuff, from the lungs to the subglottic space and safety will be measured by adverse events (AEs).


Eligibility criteria: Inclusion Criteria:

1. Age above 18 (men and women);
2. Subject is expected to receive mechanical ventilation for more than 12 hours;
3. Connection of the ETT to the AnapnoGuard system within 12 hours from intubation initiation;
4. Subject or subject's legally acceptable representative signed the Informed Consent Form

Exclusion Criteria:

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)

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Primary outcomes:
measure: CO2 Leakage Above the ETT Cuff, Measured Over Time.
timeFrame: Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days
Secondary outcomes:
measure: Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O)
timeFrame: Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days
Other outcomes:
Locations:
city: Bnei Brak
country: Israel
facility: Mayanei Hayeshua Medical Center, General ICU
city: Haifa
country: Israel
facility: Rambam Medical Center, Cardiac Surgery Department
city: Haifa
country: Israel
facility: Rambam Medical Center, Neurosurgery Department
city: Holon
country: Israel
facility: Wolfson Medical Center, General ICU
Study officials:
affiliation: Hospitech Respiration
name: Shai Efrati, MD
role: STUDY_DIRECTOR
name: Gil Bolotin, MD
role: PRINCIPAL_INVESTIGATOR
References: