Recruiting NCT06934876
Waveform Capnography Compared to Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colorimetric carbon dioxide (CO2) detection, Waveform capnography.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Waveform Capnography and Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults
Overview
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.
Interventions
- 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?"
Primary outcome measures
- 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]
Secondary outcome measures (1)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- Rush University Medical Center — Chicago
- Lahey Hospital & Medical Center — Burlington
- Hennepin Healthcare — Minneapolis
- Regions Hospital — Saint Paul
- Albany Medical Center — Albany
- Duke University School of Medicine — Durham
- Wake Forest School of Medicine — Winston-Salem
- The Ohio State University College of Medicine — Columbus
- … and 1 more center
Identifiers
NCT: NCT06934876 · IRB-FY2024-947