Metabolic AcidosisNCT06327737
Diabetic Ketoacidosis Diagnosis and Management
An observational study of Metabolic Acidosis and Diabetic Ketoacidosis, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 15 days to 18 years
- Conditions the study is for
- Metabolic Acidosis, Diabetic Ketoacidosis, Brain Edema
- What is being tested?
- Capnography
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2020to 15 Mar 2023
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Who did not give written consent were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of End-Tidal Carbon Dioxide and Integrated Pulmonary Index Monitoring With Capnography to 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.
Read the 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
- Conditions
- Metabolic Acidosis, Diabetic Ketoacidosis, Brain Edema
- Being tested
- Capnography
- Keywords
- Type 1 diabetes mellitus (Type 1 DM), Diabetic Ketoacidosis (DKA), Capnography, Blood gas, Integrated Pulmonary Index, End tidal Carbon Dioxide (EtCO2)
- Medical subject headings
- Acidosis, Diabetic Ketoacidosis, Brain Edema, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapnographyDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between PCO2 and EtCO2
The positive linear correlation between PCO2 and EtCO2 indicates that acidosis can be monitored with EtCO2.
Measured: 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
Measured: 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
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start15 Dec 2020
- Primary completion15 Nov 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Ceren Kahraman
- Responsible party
- Principal investigator, Ozlem Tolu Kendir, Akdeniz University
- Investigators
- OZLEM TOLU KENDIR, Assoc. Prof., Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327737
- Sponsor's protocol ID
- AKDENIZ-KAEK-916
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41033061
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of End-Tidal Carbon Dioxide and Integrated Pulmonary Index Monitoring With Capnography to Diabetic Ketoacidosis Diagnosis and Management
- ClinicalTrials.gov ID
- NCT06327737
- Acronym / sponsor ID
- AKDENIZ-KAEK-916
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Ceren Kahraman
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 15 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Who did not give written consent were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapnographyThis 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. | Diagnostic test | – |
Primary outcome
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Derived from this study: PubMed 41033061Kendir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
OZLEM TOLU KENDIR, Assoc. Prof. principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Acidosis and Diabetic Ketoacidosis, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between PCO2 and EtCO2 (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06327737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.