Diabetic Ketoacidosis Diagnosis and Management

NCT06327737 | Completed

• 1 other identifier: AKDENIZ-KAEK-916
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Acidosis; Diabetic Ketoacidosis; Brain Edema

Keywords

Type 1 diabetes mellitus (Type 1 DM); Diabetic Ketoacidosis (DKA); Capnography; Blood gas; Integrated Pulmonary Index; End tidal Carbon Dioxide (EtCO2)

Outcome Measures

Primary Outcomes (3)

• Correlation between PCO2 and EtCO2

  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

  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

  Detection of significant decrease in Glasgow Coma Scale (GCS\<13) in patients with Integrated Pulmonary Index \<4

  2 days

Interventions

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.

Eligibility Criteria

• Age: 15 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

During the study, 55 of 66 patients diagnosed with DKA in the pediatric emergency department of our hospital were included in the study. One of our patients was during the researcher's leave; 7 of them were excluded from the study because they were in periods when capnograph cannula was not available in our hospital and 3 of them were excluded due to patient non-compliance.

You may qualify if:

• 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.

You may not qualify if:

• Who did not give written consent were not included in the study.

Sponsors & Collaborators

• Akdeniz University: lead
• Ceren Kahraman: collaborator

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Related Publications (1)

• Kendir OT, Kahraman C, Tekerek NU, Gurlu R, Parlak M, Erkek N. The contribution of end-tidal carbon dioxide monitoring to the management of pediatric patients with diabetic ketoacidosis. Am J Emerg Med. 2026 Jan;99:151-154. doi: 10.1016/j.ajem.2025.09.050. Epub 2025 Sep 26.

  PMID: 41033061 DERIVED

MeSH Terms

Conditions

Acidosis; Diabetic Ketoacidosis; Brain Edema; Diabetes Mellitus, Type 1

Interventions

Capnography

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Ketosis; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• OZLEM TOLU KENDIR, Assoc. Prof.

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 25, 2024
• Study Start: December 15, 2020
• Primary Completion: November 15, 2022
• Study Completion: March 15, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

TU (1)