Critical Care
Conditions
Keywords
Endotracheal intubation, Mechanical ventilation, Critical care
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).
Interventions
DEVICEAnapnoGuard 100 control unit
Sponsors
Hospitech Respiration
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CO2 Leakage Above the ETT Cuff, Measured Over Time. | Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O) | Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days | 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. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions. | 34 |
| Control Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily. | 30 |
| Total | 64 |
Baseline characteristics
| Characteristic | Study | Control | Total |
|---|---|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 18.8 | 66.7 years STANDARD_DEVIATION 11.2 | 65.8 years STANDARD_DEVIATION 15.6 |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 23 Participants | 18 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 39 | 6 / 33 |
| serious Total, serious adverse events | 3 / 39 | 4 / 33 |
Outcome results
Primary
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.
Time frame: Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study | CO2 Leakage Above the ETT Cuff, Measured Over Time. | 0.09 [CO2 mmHg*hour]/hour | Standard Deviation 0.04 |
| Control | CO2 Leakage Above the ETT Cuff, Measured Over Time. | 0.22 [CO2 mmHg*hour]/hour | Standard Deviation 0.32 |
Secondary
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.
Time frame: Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study | Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O) | 0.979 normalized number of Cp measurements | Standard Deviation 0.064 |
| Control | Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O) | 0.397 normalized number of Cp measurements | Standard Deviation 0.302 |
Post Hoc
Duration of Significant CO2 Leakage
Time (minutes) of CO2 leakage readings at or above 2 mmHg
Time frame: Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study | Duration of Significant CO2 Leakage | 4.61 minutes | Standard Deviation 3.53 |
| Control | Duration of Significant CO2 Leakage | 34.53 minutes | Standard Deviation 83.27 |