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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | 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) |
|
| Control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AnapnoGuard 100 control unit | Device |
|
| 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 |
| 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 |
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Inclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Shai Efrati, MD | Hospitech Respiration | Study Director |
| Gil Bolotin, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayanei Hayeshua Medical Center, General ICU | Bnei Brak | Israel | ||||
| Rambam Medical Center, Cardiac Surgery Department |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | [CO2 mmHg*hour]/hour | Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days |
|
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Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrilation | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Manager | Hospitech Respiration | +972-3-9191648 | 5 | adir@hospitech.co.il |
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| Haifa |
| Israel |
| Rambam Medical Center, Neurosurgery Department | Haifa | Israel |
| Wolfson Medical Center, General ICU | Holon | Israel |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | normalized number of Cp measurements | Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days |
|
|
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| Post-Hoc | Duration of Significant CO2 Leakage | Time (minutes) of CO2 leakage readings at or above 2 mmHg | Posted | Mean | Standard Deviation | minutes | Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days |
|
|
|
| 39 |
| 7 |
| 39 |
| EG001 | Control | 4 | 33 | 6 | 33 |
| Hemodynamic instability | General disorders |
|
| Infection of surgery wound | Infections and infestations |
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| Melena | Gastrointestinal disorders |
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| Massive bleeding after surgery | Injury, poisoning and procedural complications |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders |
|
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