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Completed

NCT Number: NCT06327737

Diabetic Ketoacidosis Diagnosis and Management

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.

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Key information

Conditions

Metabolic Acidosis Acid-Base Imbalance Acidosis Autoimmune Diseases Brain Diseases Brain Edema Central Nervous System Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Ketoacidosis Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Ketosis Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

15 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Akdeniz University

Antalya, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capnography

Diagnostic Test

This is 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.

Primary outcomes

  1. 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. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Collaborators

  • Ceren Kahraman

Registry information

Official study title

Contribution of End-Tidal Carbon Dioxide and Integrated Pulmonary Index Monitoring With Capnography to Diabetic Ketoacidosis Diagnosis and Management

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 25, 2024
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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