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

NCT06934876 | Recruiting

• 1 other identifier: IRB-FY2024-947
• Study Type: observational
• Target: 1,332
• Locations: 1 country
• Sites: 6

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.

Conditions

Acute Respiratory Failure

Keywords

tracheal intubation; emergency intubation; waveform capnography; end-tidal CO2; exhaled carbon dioxide; colorimetric detection of exhaled carbon dioxide

Outcome Measures

Primary Outcomes (1)

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

  The co-primary endpoints are the sensitivity and specificity of each test (against the reference standard) to accurately detect the tube location. 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. The co-primary outcomes are a direct comparison of the sensitivity and specificity between the two index tests using McNemar's test with a two-sided P value with a significance level of 0.05. The McNemar's test is well-suited to paired data where both diagnostic tests are applied to the same patients. We will also present the absolute between-group difference with 95% confidence intervals.

  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.

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

Study Arms (1)

Critically ill adults undergoing emergency tracheal intubation

Adult patients who are undergoing emergency intubation in the ED and ICU

Diagnostic Test: Colorimetric carbon dioxide (CO2) detection; Diagnostic Test: Waveform capnography

Interventions

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?"

Critically ill adults undergoing emergency tracheal intubation

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?"

Critically ill adults undergoing emergency tracheal intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adult patients undergoing emergency intubation

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brian Driver: lead

Study Sites (6)

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

RECRUITING

Hennepin Healthcare

Minneapolis, Minnesota, 55415, United States

RECRUITING

Duke University School of Medicine

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

RECRUITING

The Ohio State University College of Medicine

Columbus, Ohio, 43210, United States

RECRUITING

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

RECRUITING

Central Study Contacts

Brian Driver, MD

CONTACT

6128737448; brian.driver@hcmed.org

Matthew Prekker, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: From 12 months after publication until 48 months after publication
• Access Criteria: Researchers testing a hypothesis outlined in an institutional review board approved protocol can access the full de-identified dataset. These data can be accessed by emailing the corresponding author. A signed data access agreement will be required.

Locations

US (6)