A Comparison of the Detection of Hypoventilation During Deep Sedation Utilizing Nasal End Title CO@ Versus Transcutaneous CO2 Measurement Techniques
The estimation of the partial pressure of carbon dioxide (PCO2) in the arterial blood is used to judge the adequacy of ventilation during spontaneous and controlled ventilation. Although the gold standard for monitoring PCO2 remains arterial blood gas sampling, this requires an invasive procedure and provides only an intermittent estimate of what is frequently a continuously changing value. The solution to this problem has been the development and validation of accurate noninvasive monitoring techniques which provide a continuous intraoperative estimate of PCO2.The most commonly used noninvasive technique to monitor PCO2 is measurement of the end tidal CO2 (PECO2) . However, sampling errors and patient -related issues such as ventilation-perfusion mismatch, patient positioning or decreases in pulmonary blood flow may influence the accuracy of PECO2 monitoring (1-3). Nasal capnography has been proved to be an accurate monitor during the post-operative period (4) but its ability to accurately detect hypoventilation associated with deep sedation has not been studied.
According to the American Society of Anesthesiologist standards for basic monitoring, continuous capnography is required for all patients undergoing general anesthesia but it is optional for MAC/sedation cases. The need for CO2 monitoring has been studied by other medical specialties that use procedural sedation, including gastroenterology (12) and emergency medicine (13, 14) and many specialties now recommend capnography as a standard monitor.
Patients receiving supplemental oxygen may experience significant persistent hypoventilation leading to progressive hypercarbia and acidosis which may go undetected for a significant time interval since the routinely monitored SpO2 may be maintained within normal range. A recent study has shown that despite the fact that end tidal CO2 is reliable in detecting apnea , increasing oxygen flow rates decrease the amplitude of measured CO2, probably via dilution, making the quantitative value less reliable as an assessment of adequacy of ventilation (15). Furthermore, during hypoventilation there is reduced alveolar ventilation and the end tidal CO2 is not a true reflection of arterial CO2.
Transcutaneous measurement of PCO2(PtcCO2) is a non-invasive method of measuring PCO2 that has been used much less frequently due to technical difficulties with earlier transcutaneous electrodes. Preliminary studies of the reliability of the current PtcCO2 electrodes (TOSCA, Linde Medical Sensors, and Basel, Switzerland) have shown good correlation of arterial and transcutaneous measurements in both adult volunteers and anesthetized subjects (5). PtcCO2 is measured with a sensor attached by a low pressure clip to an earlobe. The sensor probe heats the earlobe to 42 degrees Celsius to enhance blood flow. The current sensors have also been evaluated in anesthetized children (7, 8), anesthetized adults (9, 10) and critically ill neonates (11) and all these studies revealed a good correlation between PtCO2 and PaCO2.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Comparison of the Detection of Hypoventilation During Deep Sedation Utilizing Nasal End Title CO@ Versus Transcutaneous CO2 Measurement Techniques|
- Evaluate the correlation between PaCO2 - ETCO2 versus PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
- Subjects with SaO2 less than 90% on 3L oxygen by nasal cannula. Subjects requiring airway supporting measures; jaw support, oral / nasal airway. Subjects converted to general anesthesia due to inadequacy of deep sedation [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Other: Arterial blood draw
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Study Director:||Robert McCarthy, PharmD||Northwestern University|