- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06327737
Diabetic Ketoacidosis Diagnosis and Management
Contribution of End-Tidal Carbon Dioxide and Integrated Pulmonary Index Monitoring With Capnography to Diabetic Ketoacidosis Diagnosis and Management
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose: In this study, the contribution of this non-invasive follow-up method to the management of DKA and the reduction of the frequency of invasive procedures was investigated in patients diagnosed with diabetic ketoacidosis (DKA) in the pediatric emergency department and followed up with capnography
Method: This study is a prospective clinical study. Between October 2020- November 2022, EtCO2 and IPI follow-up of 0-18 year-old pediatric patients diagnosed with DKA in the Pediatric Emergency Service of Akdeniz University Medical Faculty Hospital was performed by capnography. DKA diagnosis, grading, clinical follow-up and treatment termination criteria of the patients were determined according to the ISPAD 2018 Diagnosis and Treatment Guidelines. In the study; During the clinical follow-up, changes in GCS, blood glucose, vital, blood gas and capnograph parameters were examined. Demographic data were analyzed in all patients and in groups of patients who underwent DKA grading. GCS, blood gas and capnograph parameters were compared in the patient groups with DKA grading. Diagnostic test performances of blood gas and capnograph parameters were compared to detect low GCS
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Antalya, Turkey
- Akdeniz University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The study group consisted of pediatric patients aged 0-18 years who were diagnosed with Diabetic Ketoacidosis and applied to Akdeniz University pediatric emergency department.
- Written consent was obtained.
Exclusion Criteria:
• Who did not give written consent were not included in the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between PCO2 and EtCO2
Time Frame: 2 days
|
The positive linear correlation between PCO2 and EtCO2 indicates that acidosis can be monitored with EtCO2.
|
2 days
|
Correlation between Integrated Pulmonary Index and degree of acidosis
Time Frame: 2 days
|
Detection of a positive linear correlation between those with Integrated Pulmonary Index <8 and the degree of acidosis
|
2 days
|
Prediction of cerebral edema with Integrated Pulmonary Index
Time Frame: 2 days
|
Detection of significant decrease in Glasgow Coma Scale (GCS<13) in patients with Integrated Pulmonary Index <4
|
2 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: OZLEM TOLU KENDIR, Assoc. Prof., Akdeniz University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKDENIZ-KAEK-916
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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