Acute Respiratory FailureWAVENCT06934876
Waveform Capnography Compared to Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults
An observational study of Acute Respiratory Failure, run by Brian Driver at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Colorimetric carbon dioxide (CO2) detection and Waveform capnography
- How many people
- 2,092 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Apr 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill adult patients undergoing emergency intubation
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12208
Alexander Bracey, MD, (518) 262-3125, braceya@amc.edu
- Recruiting
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Avignat Patel, MD, 781-744-5100, Avignat.S.Patel@lahey.org
- Not yet recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Kevin Buell, MD, (312) 942-5000, Kevin_Buell@rush.edu
- Recruiting
The Ohio State University College of Medicine
Columbus, Ohio, 43210
Matthew Exline, MD, 614-293-8000, Matthew.Exline@osumc.edu
- Not yet recruiting
Duke University School of Medicine
Durham, North Carolina, 27710
James Herbert, MD, PhD, (919) 684-8111, jth7@duke.edu
- Recruiting
Hennepin Healthcare
Minneapolis, Minnesota, 55415
Brian Driver, 612-873-7448, brian.driver@hcmed.org
- Recruiting
Oregon Health and Sciences University
Portland, Oregon, 97239
Akram Khan, MBBS, 503-494-8311, khana@ohsu.edu
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Bjorn Westgard, MD, (651) 254-3456, Bjorn.C.Westgard@HealthPartners.Com
- Recruiting
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
John Gaillard, MD, 336-758-5000, jgaillar@wakehealth.edu
About this study
Official title: 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.
- Conditions
- Acute Respiratory Failure
- Being tested
- Colorimetric carbon dioxide (CO2) detection, Waveform capnography
- Keywords
- tracheal intubation, emergency intubation, waveform capnography, end-tidal CO2, exhaled carbon dioxide, colorimetric detection of exhaled carbon dioxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorimetric carbon dioxide (CO2) detectionDiagnostic 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 capnographyDiagnostic 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?"
| Study group | Role | What they receive |
|---|---|---|
| Critically ill adults undergoing emergency tracheal intubation | Adult patients who are undergoing emergency intubation in the ED and ICU Receives: Diagnostic Test: Colorimetric carbon dioxide (CO2) detection; Diagnostic Test: Waveform capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start21 Apr 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,092 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brian Driver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian Driver, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934876
- Sponsor's protocol ID
- IRB-FY2024-947
- Acronym
- WAVE
- Status last verified
- May 2026
- First submitted
- 11 Apr 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waveform Capnography and Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults
- ClinicalTrials.gov ID
- NCT06934876
- Acronym / sponsor ID
- WAVE / IRB-FY2024-947
- Conditions
- Acute Respiratory Failure
- Keywords
- tracheal intubation, emergency intubation, waveform capnography, end-tidal CO2, exhaled carbon dioxide, colorimetric detection of exhaled carbon dioxide
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,092 participants (estimated)
- Lead sponsor
- Brian DriverUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill adults undergoing emergency tracheal intubation | – | Diagnostic Test: Colorimetric carbon dioxide (CO2) detection, Diagnostic Test: Waveform capnographyAdult patients who are undergoing emergency intubation in the ED and ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients undergoing emergency intubation
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorimetric carbon dioxide (CO2) detectionAll 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 | Critically ill adults undergoing emergency tracheal intubation |
| Waveform capnographyAll 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?" | Diagnostic test | Critically ill adults undergoing emergency tracheal intubation |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Brian Driver at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Driver, MD (6128737448, brian.driver@hcmed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.