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Capnography in Upper Gastrointestinal Endoscopy with the Oridion Bitebloc |
David L. Carr-Locke, M.D., F.R.C.P., Shelley Walsh Division of Gastroenterology, Brigham and Women's Hospital, Boston, MA |
Introduction: Capnography is a useful monitoring method during upper gastrointestinal endoscopy. Standard techniques such as a nasal or oral/nasal sampling cannula are limited since mouth breathing is very common during upper endoscopy. We tested the CO2 sampling performance of the Oridion Smart BiteBloc (BB) during upper endoscopy when oxygen is delivered. Method: Performance was verified by measuring: EtCO2, Respiration Rate, and CO2 waveform with the BB and with a standard 6 French nasal catheter used for sampling CO2 at the pharynx (CD, Comparison Device) in 35 patients undergoing ERCP (Endoscopic Retrograde Cholangio-Pancreatography) together to collect simultaneous breath samples for measurement with two separate Microstream® capnographs. The EtCO2 values received were recorded for at least 10 minutes (min avg of 20 minutes / patient). Supplementary oxygen was supplied per department protocol. Results: Disagreement between the BB and CD was measured by dividing CO2 results into four possible levels of results:[table1]For each system state, the severity (difference between the two devices) of the situation was graded from 0 through 3. A severity grade of 0 indicated agreement between the BB and CD devices, and was the desired level of severity. A severity grade of 3 indicated a clinically significant difference between the two devices. A severity grade of 2 indicated a significant difference between the two devices, while the severity grade of 1 indicates an undesirable difference between the two devices. The results were analyzed to determine the proportion of time the devices were in severity states 0, 1, 2, and 3. The two devices were determined to be equivalent if the following criteria were met: the system is in severity state 3 for less than 2% of the time, severity states 1 or 2 for less than 5% of the time, and is in severity states 1, 2 or 3 for less than 10% of the time. The EtCO2 readings for both sampling means (BB and CD) in mmHg from 802 minutes of sampling during ERCP were collected and calculated. The following average results were noted over the entire study period BB= 38.6 mmHg. CD = 38.4 mmHg.[table2]Results revealed the two sampling methods provided similar data. Data showed that in 92% of cases, there was agreement between the BB and CD, minimal disagreement in 7% and in 1.2% there was moderate disagreement. Performance of the BB complied with the acceptance criteria. Conclusion: The study indicated that CO2 measurement during upper endoscopy with the Oridion BiteBloc, yields similar results to CO2 measurement of patients with a standard nasal catheter. In no cases was there major disagreement between the two devices. There were no periods when the performance of the BB was misleading to a level that could have caused any incorrect reaction by the user. Anesthesiology 2008; 109 A1684 |
Table 1| Clinical Status Class | 1 | 2 | 3 | 4 | | Status Class Definition in terms of Capnograph Reading | < 7 mmHg | 7 – 25 mmHg | 25 – 50 mmHg | > 50 mmHg | | Status Class Definition in terms of the Patient's Medical Status | Patient with obstruction or Apnea | Patient with Hyperventilation or partial obstruction | Patient with normal breathing | Patient with Hypoventilation | |
Table 2| Severity Level | Percentage of Time System was in Indicated Severity State | Acceptance criteria (for Percentage of Time System was in Indicated Severity State) | | 3 (Most severe) | 0% | <2% | | > 2 (Moderate) | 1.2% | <5% | | > 1 (Minor) | 8.2% | <10% | |