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NCT Number: NCT06934876

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

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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Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rush University Medical Center, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is located in a participating unit (ED or ICU)
  • Patient is undergoing tracheal intubation.
  • The clinician intends to use an exhaled CO2 detection device to confirm tracheal placement of the tube.

Exclusion criteria

  • Patient is known to be a prisoner
  • Patient is known to be < 18 years old
  • A responsible clinician has determined that sole use of either waveform capnography or colorimetric testing is required for optimal care of the patient.

Treatment and study plan

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?"

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?"

Primary outcomes

  1. Sensitivity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned in the trachea.

    Time frame: 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 outcomes

  1. Specificity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned outside of the trachea.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Driver, MD

CONTACT

[email protected]

6128737448

Matthew Prekker, MD

CONTACT

[email protected]

612-873-7448

Sponsors and collaborators

Lead sponsor

Brian Driver

Other

Registry information

Official study title

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

Acronym: WAVE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 18, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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