Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia

Cystic Fibrosis Clinical Trial

Official title:

Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734822
• Other study ID #: IRB15-00797
• Status: Completed
• Phase: N/A
• Start date: March 10, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: March 2019
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Other:
• End tidal CO2 (EtCO2)
End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.

Device:
• Transcutaneous CO2 (TCO2)
Continuous and noninvasive real-time monitoring of transcutaneous CO2.

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Immediately following induction of anesthesia