Diabetic Ketoacidosis Diagnosis and Management

Metabolic Acidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06327737
• Other study ID #: AKDENIZ-KAEK-916
• Status: Completed
• Start date: December 15, 2020
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2024
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 15, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Days to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acidosis
• Brain Edema
• Diabetic Ketoacidosis
• Ketosis
• Metabolic Acidosis

Intervention

Diagnostic Test:
• Capnography
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.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (2)

Lead Sponsor	Collaborator
Akdeniz University	Ceren Kahraman

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between PCO2 and EtCO2	The positive linear correlation between PCO2 and EtCO2 indicates that acidosis can be monitored with EtCO2.	2 days
Primary	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
Primary	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