Protocol and Statistical Analysis Plan for the Waveform Capnography versus Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults (WAVE) Study
- 1Hennepin County Medical Center
Abstract
BackgroundDuring emergency tracheal intubation, clinicians use waveform capnography or colorimetric carbon dioxide (CO2) detection to confirm exhaled CO2 from the endotracheal tube to determine its location. Both devices reliably yield a negative result when the tube is in the esophagus. However, in most emergency intubations the tube is correctly located in the trachea, and in this circumstance the relative diagnostic accuracy of the two devices is uncertain. If one device more often fails to detect exhaled CO2 despite correct tube placement (a false negative result), this could lead to unnecessary tube removal, repeated intubation attempts, and an increased risk of serious complications.
Research QuestionAmong critically ill adults undergoing emergency tracheal intubation, is waveform capnography or colorimetric CO2 detection more sensitive for identifying an endotracheal tube correctly placed in the trachea?
Study Design and MethodsThe WAVE study is a pragmatic, prospective, paired diagnostic accuracy study conducted in emergency departments and intensive care units in the United States. The study compares waveform capnography and colorimetric CO2 detection (index tests) against a non-CO2-based reference standard for endotracheal tube location among 2,092 critically ill adults undergoing tracheal intubation. The primary outcome is the sensitivity of each index test for identifying a tube located in the trachea. The secondary outcome is specificity for identifying a tube located outside the trachea.
ResultsEnrollment began on April 21, 2025 and is ongoing, with completion anticipated in 2026.
InterpretationThe WAVE study will provide prospective evidence comparing waveform capnography with colorimetric CO2 detection for determination of endotracheal tube location in critically ill adults. These findings may inform clinical practice and guideline recommendations regarding the optimal test of exhaled CO2 for use in the ED and ICU. Prespecifying the protocol and statistical analysis plan before completion of enrollment enhances the rigor, reproducibility, and transparency of the study.
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BibTeX
@misc{robinson2026protocol,
title = {{Protocol and Statistical Analysis Plan for the Waveform Capnography versus Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults (WAVE) Study}},
author = {A. E. Robinson and M. E. Prekker and A. S. Patel and M. Waxman and J. P. Gaillard and S. Sridhar and B. C. Westgard and A. Khan and J. T. Herbert and A. L. Schick and K. G. Buell and M. Gottlieb and A. Bunting and F. Mackay and A. Bracey and J. E. Nogle and M. C. Exline and M. Dillon and V. Krishnamoorthy and K. E. Jackson and T. Alcorn and T. Haas and I. W. A. Maia and W. H. Self and T. W. Rice and M. W. Semler and J. D. Casey and L. Siegel and J. S. Koopmeiners and J. Kuo and M. A. Puskarich and B. E. Driver},
howpublished = {medRxiv},
year = {2026},
month = oct,
doi = {10.64898/2026.10.07.26364973},
url = {https://www.medrxiv.org/content/10.64898/2026.10.07.26364973v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - Protocol and Statistical Analysis Plan for the Waveform Capnography versus Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults (WAVE) Study
AU - A. E. Robinson
AU - M. E. Prekker
AU - A. S. Patel
AU - M. Waxman
AU - J. P. Gaillard
AU - S. Sridhar
AU - B. C. Westgard
AU - A. Khan
AU - J. T. Herbert
AU - A. L. Schick
AU - K. G. Buell
AU - M. Gottlieb
AU - A. Bunting
AU - F. Mackay
AU - A. Bracey
AU - J. E. Nogle
AU - M. C. Exline
AU - M. Dillon
AU - V. Krishnamoorthy
AU - K. E. Jackson
AU - T. Alcorn
AU - T. Haas
AU - I. W. A. Maia
AU - W. H. Self
AU - T. W. Rice
AU - M. W. Semler
AU - J. D. Casey
AU - L. Siegel
AU - J. S. Koopmeiners
AU - J. Kuo
AU - M. A. Puskarich
AU - B. E. Driver
PY - 2026
DA - 2026/10/07
PB - medRxiv
DO - 10.64898/2026.10.07.26364973
UR - https://www.medrxiv.org/content/10.64898/2026.10.07.26364973v1
AB - BackgroundDuring emergency tracheal intubation, clinicians use waveform capnography or colorimetric carbon dioxide (CO2) detection to confirm exhaled CO2 from the endotracheal tube to determine its location. Both devices reliably yield a negative result when the tube is in the esophagus. However, in most emergency intubations the tube is correctly located in the trachea, and in this circumstance the relative diagnostic accuracy of the two devices is uncertain. If one device more often fails to detect exhaled CO2 despite correct tube placement (a false negative result), this could lead to unnecessary tube removal, repeated intubation attempts, and an increased risk of serious complications. Research QuestionAmong critically ill adults undergoing emergency tracheal intubation, is waveform capnography or colorimetric CO2 detection more sensitive for identifying an endotracheal tube correctly placed in the trachea? Study Design and MethodsThe WAVE study is a pragmatic, prospective, paired diagnostic accuracy study conducted in emergency departments and intensive care units in the United States. The study compares waveform capnography and colorimetric CO2 detection (index tests) against a non-CO2-based reference standard for endotracheal tube location among 2,092 critically ill adults undergoing tracheal intubation. The primary outcome is the sensitivity of each index test for identifying a tube located in the trachea. The secondary outcome is specificity for identifying a tube located outside the trachea. ResultsEnrollment began on April 21, 2025 and is ongoing, with completion anticipated in 2026. InterpretationThe WAVE study will provide prospective evidence comparing waveform capnography with colorimetric CO2 detection for determination of endotracheal tube location in critically ill adults. These findings may inform clinical practice and guideline recommendations regarding the optimal test of exhaled CO2 for use in the ED and ICU. Prespecifying the protocol and statistical analysis plan before completion of enrollment enhances the rigor, reproducibility, and transparency of the study.
ER -