Protocol and Statistical Analysis Plan for the Waveform Capnography versus Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults (WAVE) Study
Year: 2026
Type: article
Study design: Study Protocol
Abstract: Background During emergency tracheal intubation, clinicians use waveform capnography or colorimetric carbon dioxide (CO 2 ) detection to confirm exhaled CO 2 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 CO 2 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 Question Among critically ill adults undergoing emergency tracheal intubation, is waveform capnography or colorimetric CO 2 detection more sensitive for identifying an endotracheal tube correctly placed in the trachea? Study Design and Methods The 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 CO 2 detection (index tests) against a non-CO 2 -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. Results Enrollment began on April 21, 2025 and is ongoing, with completion anticipated in 2026. Interpretation The WAVE study will provide prospective evidence comparing waveform capnography with colorimetric CO 2 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 CO 2 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.
Source: CHEST Critical Care
Authors: Aaron E. Robinson, Matthew E. Prekker, Avignat S. Patel, Michael Waxman, John P. Gaillard, Shilpa Sridhar, Bjorn Westgard, Akram Khan, J. Taylor Herbert, Alexandra Schick, Kevin G. Buell, Michael Gottlieb, Alec Bunting, Fraser Mackay, Alexander Bracey, Jordan E. Nogle, Matthew C. Exline, Matthew Dillon, Vijay Krishnamoorthy, Karen E. Jackson, Thomas Alcorn, Taya Haas, Ian Ward A. Maia, Wesley H. Self, Todd W. Rice, Matthew W. Semler, Jonathan D. Casey, Lianne Siegel, Joseph S. Koopmeiners, Joanna Kuo, Michael A. Puskarich, Brian E. Driver, Sharfaa Ahmed, Alexander Bracey, Briana Caban, Alana Gardner, Umair Hassan, Habiba Khan, Michael J. Waxman, J. Taylor Herbert, Mogahed Ismail Hassan Hussein, Vijay Krishnamoorthy, Jacqueline A. Quinn, Rae Staben, Anke Wang, Ian Ward A. Maia, Najma Abdilahi, Justine Acosta, Zachary Ahearn, Amal Ahmed, Adeeb Alam, Ali Alshuker, Salma Awale, Liliana Awes, Nardos Ayana, Brooke Ayano, MacKenzie Bade, Paige Banét, Jerome Barbour, Kaden Benson, Aliada Beyene, Aarya Bommidi, Brianna Bommireddipalli, Bavely Boulos, Madeleine Breton, Halcyon Brown, Selia Buchl, Alec J. Bunting, Connie Chao, Tejesh Cheepuru, Madison Crandall, Amy Diedrich, Lwandile Dlamini, Hana Dorsey, Brian E. Driver, Clara Duray, Marco Duronio, Kendra Egwim, Devin Eiden, Marissa Erickson, Chloe Greene, Taya Haas, Alexander Haddad, Salma Hamimoune, Sophia Harlin, Franciska Hauer, Abdullgadir Hayir, Paige Hillman, Samuel Holmberg, Sana Ikramuddin, Pramit Jagtap, Erik Jensen, Briana Joseph, Nicholas Kajer, Brandon Kim, Tara Kracht, Joanna Kuo, Elizabeth Kuznetsov, Razi Lawabni, Patricia Maadu, Natalie Martinez, Abrianna Meelberg, Emerson Mehring, Lilia Melco, Taylor Meyer, Afnan Mohamed, Alex Molina, Jenny Moua, Madison Mucha, Chris Mullen, Robert Murphy, Preethi Muruganandan, Ariam Mussiel, Nader Mustafa, Ishani Nandan, Hoang Phat Nguyen, Shahir Nurein, Nea Nwanokwale, Sofia Omann, Lizbet Ortiz, Oluwatobiloba Osiberu, Ian Palanga, Jacob Palmer, Gavriel Pappas, Kennedy Pexa, Anthony Pothacamury, Matthew E. Prekker, Elizabeth Preuss, Sylvia Pulkrabek, Michael A. Puskarich, Kavya Rampalli, Benjamin Reddan, Aaron E. Robinson, Carlie Sachs, Willem Schasker, Benedict Schultz, Anna Sekerak, Mason Sill, Sneha Singh, Cassandra Sosinski, Chiara Costamagna Soto, Giada Strom, Areej Suri, Amber Tacheny, Paul Thalmann, Ashwika Thotakura, Reilly Toohey, Ella Tretsven, Hiermiela Tsegai, Erika Tsukamoto, Oscar Vargo, Andrew Vollmeneder, Diana Westwood, Rebekah Zenaye, Elizabeth Zewdu, Anthony W. Gray, Fraser Mackay, Avignat S. Patel, Susan B. Stempek, Molly Verderame, Joanne M. Wozniak, Matthew C. Exline, Aiden Howard, Sarah Karow, Kristina Luikart, Shilpa Sridhar, Gabrielle Swoope, Genesis Briceno, Matthew Dillon, Aidan Flieger, Akram Khan, Jose Pena, Edvinas Pocius, Emily Tribbett, Jensina Ericksen, Tenille Fredrickson, Keith Henry, Alexandra Schick, Broc Schindler, Bjorn Westgard, Thomas Alcorn, Kevin G. Buell, Wilfredo Cruz Ayala, Kristyn Gatling, Michael Gottlieb, Karen E. Jackson, Michelle Santangelo, Joseph S. Koopmeiners, Lianne Siegel, Jonathan D. Casey, Todd W. Rice, Wesley H. Self, Matthew W. Semler, William A. Beam, John P. Gaillard, Hayn A. Jackson, Jordan E. Nogle
Language: English
Subfield: Anesthesiology and Pain Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,500
OpenAlex ID: W7223377948