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

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: End tidal CO2 (EtCO2); Device: Transcutaneous CO2 (TCO2); Diagnostic Test: Capillary CO2 (CapCO2); Diagnostic Test: Arterial blood gas (ABG)

• Registration Number: NCT03734822
• Lead Sponsor: Nationwide Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-10
• Primary Completion: 2017-12-20
• Study Completion: 2017-12-20
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-08
• Results First Submitted: 2019-01-28
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Results First Posted: 2019-03-14
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CF	End tidal CO2 (EtCO2)	Cystic fibrosis patients undergoing general anesthesia.
CF	Transcutaneous CO2 (TCO2)	Cystic fibrosis patients undergoing general anesthesia.
CF	Arterial blood gas (ABG)	Cystic fibrosis patients undergoing general anesthesia.
CF	Capillary CO2 (CapCO2)	Cystic fibrosis patients undergoing general anesthesia.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States