Clinical trial NCT06327737: Diabetic Ketoacidosis Diagnosis and Management
Official title: Contribution of End-Tidal Carbon Dioxide and Integrated Pulmonary Index Monitoring With Capnography to Diabetic Ketoacidosis Diagnosis and Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: Ceren Kahraman
First posted: 2024-03-25
Enrollment: 55
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between PCO2 and EtCO2
timeFrame: 2 days
measure: Correlation between Integrated Pulmonary Index and degree of acidosis
timeFrame: 2 days
measure: Prediction of cerebral edema with Integrated Pulmonary Index
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: OZLEM TOLU KENDIR, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: