Diabetic Ketoacidosis Diagnosis and Management

Completed

• Conditions: Diabetic Ketoacidosis; Metabolic Acidosis; Brain Edema

• Registration Number: NCT06327737
• Lead Sponsor: Akdeniz University

Brief Summary

This is the first and only study conducted on the use of capnography in children diagnosed with DKA to evaluate the initial clinical grading of DKA, monitor clinical improvement, and predict complications such as brain edema.

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 Timeline

• Study Start: 2020-12-15
• Primary Completion: 2022-11-15
• Study Completion: 2023-03-15
• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-25
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between PCO2 and EtCO2	2 days	The positive linear correlation between PCO2 and EtCO2 indicates that acidosis can be monitored with EtCO2.
Correlation between Integrated Pulmonary Index and degree of acidosis	2 days	Detection of a positive linear correlation between those with Integrated Pulmonary Index \<8 and the degree of acidosis
Prediction of cerebral edema with Integrated Pulmonary Index	2 days	Detection of significant decrease in Glasgow Coma Scale (GCS\<13) in patients with Integrated Pulmonary Index \<4

Trial Locations

Locations (1)

Akdeniz University; 🇹🇷 Antalya, Turkey