Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 576 for:    CARBON DIOXIDE AND anesthesia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: End tidal CO2 (EtCO2) Device: Transcutaneous CO2 (TCO2) Diagnostic Test: Capillary CO2 (CapCO2) Diagnostic Test: Arterial blood gas (ABG) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia
Actual Study Start Date : March 10, 2016
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
CF
Cystic fibrosis patients undergoing general anesthesia.
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734822


Locations
Layout table for location information
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
  Study Documents (Full-Text)

Documents provided by Anne May, Nationwide Children's Hospital:

Layout table for additonal information
Responsible Party: Anne May, Assistant Professor of Clinical Pediatrics, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03734822     History of Changes
Other Study ID Numbers: IRB15-00797
First Posted: November 8, 2018    Key Record Dates
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019
Last Verified: March 2019

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs