Waveform Capnography Compared to Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults

Brian Driver2,092 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,092

Conditions

Acute Respiratory Failure

Interventions

Colorimetric carbon dioxide (CO2) detectionDIAGNOSTIC_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?"

Waveform capnographyDIAGNOSTIC_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?"

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Rush University Medical Center

Chicago, Illinois, United States

NOT_YET_RECRUITING

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

RECRUITING

Hennepin Healthcare

Outcomes

Primary Outcomes

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.

Time frame: From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute

Secondary Outcomes

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).

Time frame: From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute

Central Contacts

Brian Driver, MD

CONTACT

6128737448 brian.driver@hcmed.org

Matthew Prekker, MD

CONTACT

612-873-7448 matthew.prekker@hcmed.org

Data from ClinicalTrials.gov

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