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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
End tidal CO2 (EtCO2)
Transcutaneous CO2 (TCO2)
Capillary CO2 (CapCO2)
Arterial blood gas (ABG)
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cystic Fibrosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CF

Arm Description

Cystic fibrosis patients undergoing general anesthesia.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 23, 2018
Last Updated
March 13, 2019
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03734822
Brief Title
Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia
Official Title
Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 10, 2016 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CF
Arm Type
Other
Arm Description
Cystic fibrosis patients undergoing general anesthesia.
Intervention Type
Other
Intervention Name(s)
End tidal CO2 (EtCO2)
Intervention Description
End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.
Intervention Type
Device
Intervention Name(s)
Transcutaneous CO2 (TCO2)
Other Intervention Name(s)
The SenTec Digital Monitoring System (SDMS)
Intervention Description
Continuous and noninvasive real-time monitoring of transcutaneous CO2.
Intervention Type
Diagnostic Test
Intervention Name(s)
Capillary CO2 (CapCO2)
Intervention Description
Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.
Intervention Type
Diagnostic Test
Intervention Name(s)
Arterial blood gas (ABG)
Intervention Description
Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.
Primary Outcome Measure Information:
Title
Accuracy of CO2 Levels
Description
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.
Time Frame
Immediately following induction of anesthesia

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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