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Four methods are routinely used to monitor CO2 in patients. End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. CO2 is also monitored in other healthcare settings transcutaneously (TCO2), via finger stick capillary CO2 (CapCO2), and arterial blood gas (ABG). The purpose of this study is to perform all four measurements simultaneously during general anesthesia to identify which measure provides the most accurate data with the least amount of patient risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CF | Other | Cystic fibrosis patients undergoing general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| End tidal CO2 (EtCO2) | Other | End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of CO2 Levels | Looking at the accuracy of CO2 levels assessed via end tidal CO2 (ETCO2), capillary CO2 (Cap-CO2), and transcutaneous CO2 (TCCO2) compared to arterial blood gas (ABG) which is the gold standard. | Immediately following induction of anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cystic Fibrosis | Cystic fibrosis patients undergoing general anesthesia. End tidal CO2 (EtCO2): End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. Transcutaneous CO2 (TCO2): Continuous and noninvasive real-time monitoring of transcutaneous CO2. Capillary CO2 (CapCO2): Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer. Arterial blood gas (ABG): Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cystic Fibrosis | Cystic fibrosis patients undergoing general anesthesia. End tidal CO2 (EtCO2): End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. Transcutaneous CO2 (TCO2): Continuous and noninvasive real-time monitoring of transcutaneous CO2. Capillary CO2 (CapCO2): Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer. Arterial blood gas (ABG): Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy of CO2 Levels | Looking at the accuracy of CO2 levels assessed via end tidal CO2 (ETCO2), capillary CO2 (Cap-CO2), and transcutaneous CO2 (TCCO2) compared to arterial blood gas (ABG) which is the gold standard. | Posted | Mean | Standard Deviation | mmHg | Immediately following induction of anesthesia |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cystic Fibrosis | Cystic fibrosis patients undergoing general anesthesia. End tidal CO2 (EtCO2): End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. Transcutaneous CO2 (TCO2): Continuous and noninvasive real-time monitoring of transcutaneous CO2. Capillary CO2 (CapCO2): Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer. Arterial blood gas (ABG): Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne May, MD | Nationwide Children's Hospital | 614-722-4766 | Anne.May@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2015 | Feb 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001784 | Blood Gas Analysis |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Transcutaneous CO2 (TCO2) | Device | Continuous and noninvasive real-time monitoring of transcutaneous CO2. |
|
|
| Capillary CO2 (CapCO2) | Diagnostic Test | Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer. |
|
| Arterial blood gas (ABG) | Diagnostic Test | Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI (kg/m2) | Median | Inter-Quartile Range | Kg/m2 |
|
| FEV1% | FEV1 is the maximal amount of air you can forcefully exhale in one second. It is then converted to a percentage of normal. FEV1 greater 80% of predicted= normal, FEV1 60% to 79% of predicted = Mild obstruction, FEV1 40% to 59% of predicted = Moderate obstruction, FEV1 less than 40% of predicted = Severe obstruction | Mean | Standard Deviation | percentage of normal |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D008919 | Investigative Techniques |