Acute Respiratory Failure
Conditions
Keywords
tracheal intubation, emergency intubation, waveform capnography, end-tidal CO2, exhaled carbon dioxide, colorimetric detection of exhaled carbon dioxide
Brief summary
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.
Interventions
DIAGNOSTIC_TESTColorimetric carbon dioxide (CO2) detection
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?"
DIAGNOSTIC_TESTWaveform capnography
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?"
Sponsors
Brian Driver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is located in a participating unit (ED or ICU) 2. Patient is undergoing tracheal intubation. 3. The clinician intends to use an exhaled CO2 detection device to confirm tracheal placement of the tube.
Exclusion criteria
1. Patient is known to be a prisoner 2. Patient is known to be \< 18 years old 3. A responsible clinician has determined that sole use of either waveform capnography or colorimetric testing is required for optimal care of the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned in the trachea. | From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned outside of the trachea. | From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute | 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). |
Countries
United States
Contacts
CONTACTBrian Driver, MD
CONTACTMatthew Prekker, MD
Outcome results
None listed