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

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ClinicalTrials.gov Identifier: NCT03734822
Recruitment Status : Completed
First Posted : November 8, 2018
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Anne May, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE October 23, 2018
First Posted Date  ICMJE November 8, 2018
Results First Submitted Date  ICMJE January 28, 2019
Results First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 14, 2019
Actual Study Start Date  ICMJE March 10, 2016
Actual Primary Completion Date December 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
Accuracy of CO2 Levels [ Time Frame: Immediately following induction of anesthesia ]
Looking at the accuracy of CO2 levels assessed via end tidal CO2, capillary CO2, and transcutaneous CO2 compared to arterial blood gas which is the gold standard.
Change History Complete list of historical versions of study NCT03734822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia
Official Title  ICMJE Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • 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.
    Other Name: The SenTec Digital Monitoring System (SDMS)
  • Diagnostic Test: Capillary CO2 (CapCO2)
    Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.
  • Diagnostic Test: Arterial blood gas (ABG)
    Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.
Study Arms  ICMJE CF
Cystic fibrosis patients undergoing general anesthesia.
Interventions:
  • Other: End tidal CO2 (EtCO2)
  • Device: Transcutaneous CO2 (TCO2)
  • Diagnostic Test: Capillary CO2 (CapCO2)
  • Diagnostic Test: Arterial blood gas (ABG)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2019)
47
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2018)
60
Actual Study Completion Date  ICMJE December 20, 2017
Actual Primary Completion Date December 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03734822
Other Study ID Numbers  ICMJE IRB15-00797
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne May, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nationwide Children's Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP