Comparing waveform capnography and color-change CO2 detectors to confirm tube placement during intubation

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

This study will test whether waveform capnography or color-change CO2 detectors better confirm endotracheal tube placement in critically ill adults during intubation.

Quick facts

• Study type: Observational
• Enrollment: 2092 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hennepin Healthcare Research Institute (other)
• Locations: 9 sites (Chicago, Illinois and 8 other locations)
• Trial ID: NCT06934876 on ClinicalTrials.gov

What this trial studies

This observational multicenter study will record use of waveform capnography and colorimetric CO2 detectors during tracheal intubation in adult patients cared for in emergency departments and intensive care units. Clinicians will use the exhaled CO2 device they intend to use for confirmation, and researchers will collect device readings and clinical confirmation data. The study will compare sensitivity, specificity, and timing of confirmation for the two device types across procedures at three hospitals. The primary aim is to determine which method more reliably identifies tracheal versus esophageal tube placement in critically ill adults.

Who should consider this trial

Good fit: Adults (18 or older) in the ED or ICU at a participating site who are undergoing tracheal intubation and for whom the clinician plans to use an exhaled CO2 detection device are ideal candidates.

Not a fit: Patients under 18, known prisoners, or those for whom the treating clinician requires exclusive use of one confirmation method are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, the findings could help clinicians choose the faster or more accurate CO2 detection method to reduce misplaced tubes and related complications.

How similar studies have performed: Prior research, primarily in operating rooms and some emergency settings, has generally found waveform capnography to be more reliable than colorimetric CO2 detectors, though evidence specifically in critically ill adults during emergency intubation is more limited.

Eligibility criteria

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.

Where this trial is running

Chicago, Illinois and 8 other locations

• Rush University Medical Center — Chicago, Illinois, United States (NOT_YET_RECRUITING)
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States (RECRUITING)
• Hennepin Healthcare — Minneapolis, Minnesota, United States (RECRUITING)
• Regions Hospital — Saint Paul, Minnesota, United States (RECRUITING)
• Albany Medical Center — Albany, New York, United States (RECRUITING)
• Duke University School of Medicine — Durham, North Carolina, United States (NOT_YET_RECRUITING)
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States (RECRUITING)
• The Ohio State University College of Medicine — Columbus, Ohio, United States (RECRUITING)
• Oregon Health and Sciences University — Portland, Oregon, United States (RECRUITING)

Study contacts

• Study coordinator: Brian Driver, MD

Conditions: Acute Respiratory Failure, tracheal intubation, emergency intubation, waveform capnography, end-tidal CO2, exhaled carbon dioxide, colorimetric detection of exhaled carbon dioxide