Cystic Fibrosis
Conditions
Brief summary
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.
Interventions
OTHEREnd tidal CO2 (EtCO2)
End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.
DEVICETranscutaneous CO2 (TCO2)
Continuous and noninvasive real-time monitoring of transcutaneous CO2.
DIAGNOSTIC_TESTCapillary CO2 (CapCO2)
Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.
DIAGNOSTIC_TESTArterial blood gas (ABG)
Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype) * Hemodynamically stable undergoing general anesthesia for a scheduled procedure
Exclusion criteria
* Patients not diagnosed with CF * CF patients undergoing anesthesia for emergency procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of CO2 Levels | Immediately following induction of anesthesia | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Cystic Fibrosis | — |
|---|---|---|
| Age, Continuous | 13.4 years STANDARD_DEVIATION 7.8 | — |
| BMI (kg/m2) | 18.7 Kg/m2 | — |
| FEV1% | 87.3 percentage of normal STANDARD_DEVIATION 18.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 47 participants | — |
| Sex: Female, Male Female | 25 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
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.
Time frame: Immediately following induction of anesthesia
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cystic Fibrosis | Accuracy of CO2 Levels | PaCO2 from ABG | 48.9 mmHg | Standard Deviation 7.9 |
| Cystic Fibrosis | Accuracy of CO2 Levels | ETCO2 | 39.5 mmHg | Standard Deviation 6.2 |
| Cystic Fibrosis | Accuracy of CO2 Levels | TCCO2 | 41.5 mmHg | Standard Deviation 9.4 |
| Cystic Fibrosis | Accuracy of CO2 Levels | Cap-CO2 | 44.3 mmHg | Standard Deviation 8.6 |