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The aim of this study is to verify the safety and accuracy of an FDA-approved device called the NEMOâ„¢ Gauge to aide in the proper positioning of the endotracheal tube (ETT), inserted in the lungs of patients admitted to the intensive care unit. The hope is that the NEMOâ„¢ Gauge is able to properly determine the correct position of the endotracheal tube without the use of a chest radiograph (chest x-ray). The study investigators anticipate sixty-eight (68) subjects will participate in this study at three (3) study centers in the Inland Empire of Southern California, with subjects being enrolled at Loma Linda University Medical Center, Riverside University Medical Center and Loma Linda Veterans Affairs Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEMO Gauge | Experimental | Measurement and adjustment of endotracheal tube position by stylet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEMO Gauge | Device | Measurement and adjustment of endotracheal tube position by stylet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Correct Endotracheal Tube Position | The number of patients with correct Endotracheal tube position | Immediate, post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. Bryant Nguyen, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States | ||
| VA Loma Linda Healthcare System |
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| ID | Title | Description |
|---|---|---|
| FG000 | NEMO Gauge | Measurement and adjustment of endotracheal tube position by stylet. NEMO Gauge: Measurement and adjustment of endotracheal tube position by stylet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NEMO Gauge | Baseline Characteristics |
| 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 | Number of Correct Endotracheal Tube Position | The number of patients with correct Endotracheal tube position | Posted | Count of Participants | Participants | Immediate, post-intervention |
|
|
1 year
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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 | NEMO Gauge | Measurement and adjustment of endotracheal tube position by stylet. NEMO Gauge: Measurement and adjustment of endotracheal tube position by stylet. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Bryant Nguyen, MD | Loma Linda University | 909-558-4000 | hbnguyen@llu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2016 | Mar 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Loma Linda |
| California |
| 92357 |
| United States |
| Riverside University Medical Center | Moreno Valley | California | 92555 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Acute Respiratory Failure (Reason for Admission) | Reason for Admission | Count of Participants | Participants |
|
| Sepsis (Reason for Admission) | Reason for Admission | Count of Participants | Participants |
|
| Gastrointestinal (Reason for Admission) | Reason for Admission | Count of Participants | Participants |
|
| Neuromuscular (Reason for Admission) | Reason for Admission | Count of Participants | Participants |
|
| Shock on vasopressors (Reason for Admission) | Reason for Admission | Count of Participants | Participants |
|
| Cardiac (Reason for Admission) | Reason for Admission | Count of Participants | Participants |
|
| Renal (Reason for Admission) | Reason for Admission | Count of Participants | Participants |
|
| Other (Reason for Admission) | Reason for Admission | Count of Participants | Participants |
|
| Endotracheal Size 7 mm | Count of Participants | Participants |
|
| Endotracheal Size 7.5 mm | Count of Participants | Participants |
|
| Endotracheal Size 8 mm | Count of Participants | Participants |
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
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