Evaluating Air Leak Detection in Intubated Patients

Study Overview
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Brief Summary
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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).

Official Title
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A Study to Evaluate Air Leak Detection Above the Endotracheal Cuff in Intubated Patients Using the AnapnoGuard 100 System

Conditions
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Critical Care

Intervention / Treatment
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* Device: AnapnoGuard 100 control unit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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) -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Subjects in the study group will be connected to the AnapnoGuard 100 control unit operating in the normal clinical mode (automatic CO2 leak measurement above the cuff, cuff pressure control, evacuation of secretions and tracheal rinsing) | Device: AnapnoGuard 100 control unit<br> <br> |
| Active Comparator: Control group<br>Subjects in the control group will be connected to the AnapnoGuard 100 control unit. In the control group, the cuff pressure control of the AnapnoGuard 100 control unit will be disabled (OFF). CO2 level above the cuff will be recorded. Suction and rinsing function will operate after the system detects no CO2. | Device: AnapnoGuard 100 control unit<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CO2 Leakage Above the ETT Cuff, Measured Over Time. | Trial outcome measure represents patients' exposure to CO2 leakage standardized per hour. Specifically, each patients' area under the curve (AUC) of CO2 leakage (mmHg) is computed over the whole trial by multiplying leakage duration (X-axis; continuous time) by CO2 level (Y-axis; mmHg), divided by the patient's number of hours in the trial. Outcome measure is thus [CO2 mmHg*hour]/hour. CO2 leakage is the concentration of CO2 above the cuff as measured by the AG100 system every few minutes (in clinical mode). Time points which created the curve were every two adjacent time intervals having a valid CO2 reading. | Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O) | mean number of cuff pressure measurements within the safety accepted range of 24 and 40 cmH2O, normalized using the total number of valid cuff pressure measurements. | Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endotracheal intubation, Mechanical ventilation, Critical care