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LETTER TO THE EDITOR

Caution When Using Colorimetry to Confirm Endotracheal Intubation

Nellcor Puritan Bennett; 4280 Hacienda Drive; Pleasanton, CA 94588; steven.brackney{at}tycohealthcare.com

In Response:

As Drs. Srinivasa and Kodali (1) indicate, the use of end-tidal carbon dioxide (Etco₂) monitoring during cardiopulmonary resuscitation is an accepted adjunct to clinical assessment when verifying correct endotracheal tube placement. This view has also been accepted by a number of medical associations and societies, including the American Society of Anesthesiologists, the American Association for Respiratory Care and the American Heart Association. All of these guidelines state that clinicians may either measure or monitor Etco₂ during cardiopulmonary resuscitation via a quantitative method such as capnography or a qualitative method, using a colorimetric CO₂ detector such as the Nellcor® Easy Cap® II CO₂ detector.

It is important for users to note that the Directions for Use for the Easy Cap II CO₂ Detector includes the warning that "Interpreting results before confirming six breath cycles can yield false results. Gastric distension with air prior to attempted intubation may introduce CO₂ levels as high as 4.5% into the Easy Cap detector if the endotracheal tube is misplaced in the esophagus. Initial Easy Cap detector color (yellow) may be interpreted as a false positive if read before delivery of six breaths." The warnings also further include a statement that "Reflux of gastric contents, mucus, edema fluid, or intratracheal epinephrine into the Easy Cap can yield persistent patchy yellow or white discoloration which does not vary with the respiratory cycle. Contamination of this type may also increase airway resistance and affect ventilation. Discard device if this occurs."

Like many small, single-patient-use medical devices, it is not possible to place all directions for use, or even all warnings, directly on the package. Easy Cap II CO₂ detectors are used in numerous countries outside of the United States and are CE marked. Under CE marking requirements, placement of any text on the outside packaging—other than product codes, expiration date, lot number, and product brand—requires that text to be included in all CE market languages. As current CE requirements include a minimum of 18 languages, it is not practical to place all instructions for use, indications, contraindications, and warnings on the outside of a 6 in x 6 in foil pouch. We have chosen to include the Indications for Use on the foil pouch and the statement "Attention, See Instructions for Use," along with the appropriate internationally-recognized symbol as referenced in EN 980:2003 Graphical Symbols for Use in the Labeling of Medical Devices, for referring the users to see accompanying documents.

The Advanced Cardiac Life Support and Advanced Trauma Life Support courses conducted by the American Heart Association and the American College of Surgeons, respectively, provide the techniques for airway management. Regardless of the techniques taught in the course curriculum, all clinicians are personally responsible for training and education of the products they use in clinical practice. The Easy Cap II and Pedi-Cap Directions for Use are complete and comprehensive and are written in multiple languages for users the world over. In addition to the Directions for Use supplied in each case, Nellcor (Tyco Healthcare) offers a range of educational materials for the Easy Cap II CO₂ detector to customers free of charge. Some of these materials, including additional copies of the Directions for Use, may be downloaded from www.Nellcor.com, free of charge. In addition, Nellcor offers a wall placard detailing the use of the Easy Cap II and Pedi-Cap CO₂ detectors for display in areas where these products are likely to be used. This placard (product code RS03000) is also available free of charge and can be requested through Customer Service at 1-800-635-5267, press option 1, or by contacting your Nellcor sales representative.

REFERENCE

1. Srinivasa V, Kodali BS. Caution when using colorimetry to confirm endotracheal intubation. Anesth Analg 2007;104:738–9.[Free Full Text]

This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via Web of Science (1) Citing Articles via Google Scholar Google Scholar Articles by Brackney, S. M. Articles by Bennett, N. P. Search for Related Content PubMed Articles by Brackney, S. M. Articles by Bennett, N. P.