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

NCT ID: NCT06934876

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1332 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-21

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically ill adults undergoing emergency tracheal intubation

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

Colorimetric carbon dioxide (CO2) detection

Intervention Type 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?"

Waveform capnography

Intervention Type 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?"

Interventions

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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?"

Intervention Type 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?"

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brian Driver

OTHER

Sponsor Role lead

Responsible Party

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Brian Driver

Co-Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Site Status RECRUITING

Hennepin Healthcare

Minneapolis, Minnesota, United States

Site Status RECRUITING

Duke University School of Medicine

Durham, North Carolina, United States

Site Status NOT_YET_RECRUITING

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Site Status RECRUITING

The Ohio State University College of Medicine

Columbus, Ohio, United States

Site Status RECRUITING

Oregon Health and Sciences University

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brian Driver, MD

Role: CONTACT

6128737448

Matthew Prekker, MD

Role: CONTACT

612-873-7448

Facility Contacts

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Avignat Patel, MD

Role: primary

781-744-5100

Brian Driver

Role: primary

612-873-7448

James Herbert, MD, PhD

Role: primary

(919) 684-8111

John Gaillard, MD

Role: primary

336-758-5000

Matthew Exline, MD

Role: primary

614-293-8000

Akram Khan, MBBS

Role: primary

503-494-8311

Other Identifiers

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IRB-FY2024-947

Identifier Type: -

Identifier Source: org_study_id

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