Trial Outcomes & Findings for Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia (NCT NCT03734822)
NCT ID: NCT03734822
Last Updated: 2019-03-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Immediately following induction of anesthesia
Results posted on
2019-03-14
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cystic Fibrosis
n=47 Participants
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.
|
|---|---|
|
Age, Continuous
|
13.4 years
STANDARD_DEVIATION 7.8 • n=47 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=47 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=47 Participants
|
|
BMI (kg/m2)
|
18.7 Kg/m2
n=47 Participants
|
|
FEV1%
|
87.3 percentage of normal
STANDARD_DEVIATION 18.3 • n=47 Participants
|
PRIMARY outcome
Timeframe: Immediately following induction of anesthesiaLooking 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.
Outcome measures
| Measure |
Cystic Fibrosis
n=47 Participants
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.
|
|---|---|
|
Accuracy of CO2 Levels
PaCO2 from ABG
|
48.9 mmHg
Standard Deviation 7.9
|
|
Accuracy of CO2 Levels
ETCO2
|
39.5 mmHg
Standard Deviation 6.2
|
|
Accuracy of CO2 Levels
TCCO2
|
41.5 mmHg
Standard Deviation 9.4
|
|
Accuracy of CO2 Levels
Cap-CO2
|
44.3 mmHg
Standard Deviation 8.6
|
Adverse Events
Cystic Fibrosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place