Recruiting

Waveform Capnography vs. Colorimetric Detection

Sponsor:

Brian Driver

Code:

NCT06934876

Conditions

Acute Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Colorimetric carbon dioxide (CO2) detection

Waveform capnography

Study Details

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

Study ID

NCT06934876

Start date

Apr 21, 2025

Status verified date

May, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2092 participants

Anticipated

Interventions and Outcome Measures

Arms

Critically ill adults undergoing emergency tracheal intubation

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

Interventions

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?"

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?"

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 ]

Central Contacts and Locations

Central contacts

Brian Driver, MD

6128737448brian.driver@hcmed.org

Matthew Prekker, MD

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

Locations

Lahey Hospital & Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Avignat Patel, MD

781-744-5100Avignat.S.Patel@lahey.org

Hennepin Healthcare

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Brian Driver

612-873-7448brian.driver@hcmed.org

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Bjorn Westgard, MD

(651) 254-3456Bjorn.C.Westgard@HealthPartners.Com

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Alexander Bracey, MD

(518) 262-3125braceya@amc.edu

Wake Forest School of Medicine

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

John Gaillard, MD

336-758-5000jgaillar@wakehealth.edu

The Ohio State University College of Medicine

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Matthew Exline, MD

614-293-8000Matthew.Exline@osumc.edu

Oregon Health and Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Akram Khan, MBBS

503-494-8311khana@ohsu.edu

More Information

Sponsor

Brian Driver

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brian Driver on 2026-05-11.