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This study will compare the sensitivity and specificity of waveform capnography versus colorimetric carbon dioxide detection to identify tracheal placement of the endotracheal tube during intubation of critically ill adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically ill adults undergoing emergency tracheal intubation | Adult patients who are undergoing emergency intubation in the ED and ICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colorimetric carbon dioxide (CO2) detection | Diagnostic Test | All patients will undergo colorimetric carbon dioxide (CO2) detection. The reading will be assessed by a clinician at the bedside who will answer yes or no to the following question, asked after 7 breaths have been delivered following intubation: "Is the color change consistent with a tube located in the trachea?" |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned in the trachea. | The primary endpoint is the sensitivity of each test (against the reference standard) to accurately detect the tube location within the trachea. The sensitivity of each CO2 detection method describes the probability that the CO2 detection method is consistent with a tube location in the trachea for a patient who has an endotracheal tube located inside the trachea. | From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned outside of the trachea. | The secondary endpoint is the specificity of each test (against the reference standard) to accurately detect the tube location outside of the trachea. The specificity of each CO2 detection method describes the probability that the CO2 detection method is consistent with non-tracheal tube location for a patient who has an endotracheal tube located outside the trachea (e.g., esophageal intubation). |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill adult patients undergoing emergency intubation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Driver, MD | Contact | 6128737448 | brian.driver@hcmed.org | |
| Matthew Prekker, MD | Contact | 612-873-7448 | matthew.prekker@hcmed.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Not yet recruiting | Chicago | Illinois | 60612 | United States |
The authors will share the full de-identified dataset beginning 12 months after publication until 48 months after publication for researchers testing a hypothesis outlined in an institutional review board approved protocol. These data can be accessed by emailing the corresponding author. A signed data access agreement will be required.
From 12 months after publication until 48 months after publication
Researchers testing a hypothesis outlined in an institutional review board approved protocol can access the full de-identified dataset. These data can be accessed by emailing the corresponding author. A signed data access agreement will be required.
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| Waveform capnography | Diagnostic Test | All patients will undergo waveform capnography. The reading will be assessed by a clinician at the bedside who will answer yes or no to the following question, asked after 7 breaths have been delivered following intubation: " Is the waveform consistent with a tube located in the trachea?" |
|
| From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute |
| Lahey Hospital & Medical Center | Recruiting | Burlington | Massachusetts | 01805 | United States |
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| Hennepin Healthcare | Recruiting | Minneapolis | Minnesota | 55415 | United States |
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| Regions Hospital | Recruiting | Saint Paul | Minnesota | 55101 | United States |
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| Albany Medical Center | Recruiting | Albany | New York | 12208 | United States |
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| Duke University School of Medicine | Not yet recruiting | Durham | North Carolina | 27710 | United States |
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| Wake Forest School of Medicine | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| The Ohio State University College of Medicine | Recruiting | Columbus | Ohio | 43210 | United States |
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| Oregon Health and Sciences University | Recruiting | Portland | Oregon | 97239 | United States |
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