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

Waveform Capnography and 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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Diagnostic test: Colorimetric carbon dioxide (CO2) detection; Diagnostic test: Waveform capnography

• Study Type: Observational
• Enrollment (Estimated): 2092

Contacts and Locations

• Study Contact: Name: Brian Driver, MD; Phone Number: 6128737448; Email: brian.driver@hcmed.org
• Study Contact Backup: Name: Matthew Prekker, MD; Phone Number: 612-873-7448; Email: matthew.prekker@hcmed.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Not yet recruiting
      • Rush University Medical Center
      • Contact: Kevin Buell, MD; Phone Number: (312) 942-5000; Email: Kevin_Buell@rush.edu
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Recruiting
      • Lahey Hospital & Medical Center
      • Contact: Avignat Patel, MD; Phone Number: 781-744-5100; Email: Avignat.S.Patel@lahey.org
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Recruiting
      • Hennepin Healthcare
      • Contact: Brian Driver; Phone Number: 612-873-7448; Email: brian.driver@hcmed.org
    • Saint Paul, Minnesota, United States, 55101
      • Recruiting
      • Regions Hospital
      • Contact: Bjorn Westgard, MD; Phone Number: (651) 254-3456; Email: Bjorn.C.Westgard@HealthPartners.Com
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center
      • Contact: Alexander Bracey, MD; Phone Number: (518) 262-3125; Email: braceya@amc.edu
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Not yet recruiting
      • Duke University School of Medicine
      • Contact: James Herbert, MD, PhD; Phone Number: (919) 684-8111; Email: jth7@duke.edu
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest School of Medicine
      • Contact: John Gaillard, MD; Phone Number: 336-758-5000; Email: jgaillar@wakehealth.edu
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University College of Medicine
      • Contact: Matthew Exline, MD; Phone Number: 614-293-8000; Email: Matthew.Exline@osumc.edu
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Sciences University
      • Contact: Akram Khan, MBBS; Phone Number: 503-494-8311; Email: khana@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Critically ill adult patients undergoing emergency intubation

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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?"; Diagnostic test: Waveform capnography; 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?"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute

Collaborators and Investigators

• Sponsor: Brian Driver

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: tracheal intubation; exhaled carbon dioxide; end-tidal CO2; waveform capnography; emergency intubation; colorimetric detection of exhaled carbon dioxide
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: IRB-FY2024-947

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The authors will share the full de-identified dataset beginning 12 months after publication until 48 months after publication for researchers testing a hypothesis outlined in an institutional review board approved protocol. These data can be accessed by emailing the corresponding author. A signed data access agreement will be required.
• IPD Sharing Time Frame: From 12 months after publication until 48 months after publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No