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

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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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

End tidal CO2 (EtCO2)

Other

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

Transcutaneous CO2 (TCO2)

Device

Continuous and noninvasive real-time monitoring of transcutaneous CO2.

Other names: The SenTec Digital Monitoring System (SDMS)

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.

Primary outcomes

Accuracy of CO2 Levels

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Nov 8, 2018
Registry last updated: Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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