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

ConditionAcute Respiratory Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBrian Driver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Critically ill adult patients undergoing emergency intubation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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?"

Treatment groups

2,092 Participants
are divided into 1 treatment group
Group A: Critically ill adults undergoing emergency tracheal intubation2 interventions

Trial outcomes

Primary outcomes

1

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

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brian Driver

Lead sponsor

Hennepin Healthcare Research Institute

Sponsor institution

Source ClinicalTrials.gov
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