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RecruitingNCT06934876WAVEUpdated May 11, 2026

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

An observational study in Acute Respiratory Failure, sponsored by Brian Driver. Recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Brian Driver · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,092
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Failure

Keywords

  • tracheal intubation
  • emergency intubation
  • waveform capnography
  • end-tidal CO2
  • exhaled carbon dioxide
  • colorimetric detection of exhaled carbon dioxide
03

In context

Lead sponsor

This is the only study on the registry with Brian Driver as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically ill adult patients undergoing emergency intubation

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,092 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testColorimetric 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 testWaveform 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?"

06

What researchers measure

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

07

Study locations

7 of 9 sites recruiting
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
    Not yet recruiting
  • Lahey Hospital & Medical Center
    Burlington, Massachusetts 01805, United States
    Recruiting
  • Hennepin Healthcare
    Minneapolis, Minnesota 55415, United States
    Recruiting
  • Regions Hospital
    Saint Paul, Minnesota 55101, United States
    Recruiting
  • Albany Medical Center
    Albany, New York 12208, United States
    Recruiting
  • Duke University School of Medicine
    Durham, North Carolina 27710, United States
    • James Herbert, MD, PhD · Contact · jth7@duke.edu · (919) 684-8111
    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
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06934876
Lead sponsor
Brian Driver
Responsible party
Brian Driver (Co-Principal Investigator, Hennepin Healthcare Research Institute) — Sponsor-investigator
First posted
Apr 18, 2025
Start date
Apr 21, 2025
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
May 11, 2026

Study contacts

Brian Driver, MD
Contact
brian.driver@hcmed.org
6128737448
Matthew Prekker, MD
Contact
matthew.prekker@hcmed.org
612-873-7448

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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