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

NCT03734822 | Completed Results FDA Device

• 1 other identifier: IRB15-00797
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CF

OTHER

Cystic fibrosis patients undergoing general anesthesia.

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

Interventions

End tidal CO2 (EtCO2) OTHER

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

CF

Transcutaneous CO2 (TCO2) DEVICE

Continuous and noninvasive real-time monitoring of transcutaneous CO2.

Also known as: The SenTec Digital Monitoring System (SDMS)

CF

Capillary CO2 (CapCO2) DIAGNOSTIC_TEST

Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.

CF

Arterial blood gas (ABG) DIAGNOSTIC_TEST

Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.

CF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients not diagnosed with CF
• CF patients undergoing anesthesia for emergency procedures

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Results Point of Contact

• Title: Anne May, MD
• Organization: Nationwide Children's Hospital

Anne.May@nationwidechildrens.org

614-722-4766

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 8, 2018
• Study Start: March 10, 2016
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: March 14, 2019
• Results First Posted: March 14, 2019

Record last verified: 2019-03

Locations

US (1)