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EtCO2 for Monitoring and Predicting Severity of DKA in Pediatric Emergency, Doha, Qatar.

EtCO2 for Monitoring and Predicting Severity of DKA in Pediatric Emergency, Doha, Qatar.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04121572
Enrollment
150
Registered
2019-10-10
Start date
2019-10-10
Completion date
2024-12-31
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetic ketoacidosis, End tidal carbon dioxide, Capnography

Brief summary

Metabolic acidosis is one of the important and life-threatening pathophysiological changes in DKA and its monitoring is essential. It is known that the level of carbon dioxide (CO2) in the blood is correlating with the degree of metabolic acidosis. The CO2 level can be measured via the exhaled air by nasal cannula capnography (EtCO2) which is currently utilized to monitor the patient ventilation in many situations. Our primary objective is to study the degree of correlation between continuous EtCO2 monitoring and the severity of metabolic acidosis in blood gas measurement in patients with diabetic keto-acidosis (DKA). Secondary objectives are: ability of EtCO2 in ruling in or out DKA; discriminating the different severity grades of DKA. It is a cross-sectional, observational, prospective cohort study in convenience sample of children presenting with clinical manifestations consistent with DKA. Will be conducted in pediatric Emergency Center, Hamad General Hospital. Will include all DKA patients and excluding any condition or medication that affect the acid-base status.

Detailed description

The study will be conducted in pediatric emergency center, Hamad General Hospital, a recognized academic institution, in Doha, Qatar. The DKA was defined as: hyperglycemia (blood glucose \>11 mmol/L or 200 mg/dL), venous pH \<7.3 and/ or bicarbonate \<15 mmol/L, and the association with, ketonemia, and ketonuria. The severity of DKA is categorized as mild (venous pH \<7.3 or bicarbonate \<15 mmol/L), moderate (venous pH \<7.2 or bicarbonate \< 10 mmol/L) and severe (venous pH \< 7.1 or bicarbonate \<5 mmol/L). Eligible patients are all children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not. The patients with the following criteria are excluded: older than 14 years of age, airway obstruction, chest infection, complex congenital heart disease, Congestive heart failure, central or peripheral neurological disorders, hyper/hypothermia, and sever pain. Physicians and nurses, and research assistance staff will be trained in the use of nasal capnography including the proper size, connection and wave forms shapes and its interpretation.

Interventions

DEVICENasal cannula capnography

Capnography: a continuous wave form of the CO2 level with the digital reading of CO2 level at end of expiration

Sponsors

Hamad Medical Corporation
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
Yes

Inclusion criteria

All children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not.

Exclusion criteria

1. Older than 14 years of age 2. Airway obstruction 3. Chest infection 4. Complex congenital heart disease 5. Congestive heart failure 6. Central or peripheral neurological disorders 7. Hyper/hypothermia 8. Severe pain

Design outcomes

Primary

MeasureTime frameDescription
To utilize capnography as a noninvasive tool for the detection and monitoring of DKA2 yearsCapnography measures exhaled CO2 which is an indicator of the presence and severity of metabolic acidosis caused by DKA.

Secondary

MeasureTime frameDescription
To find the ability of EtCO2 in ruling in or out DKA2 yearsby correlating the of exhaled CO2 level to the level of Bicarbonate level in blood sample we can assess if the patient is having DKA on arrival or had it and get out of it during the management

Other

MeasureTime frameDescription
To evaluate the different severity grades of DKA using EtCO2 Monitoring2yearsby correlating the severity of DKA based on the bicarbonate level to the exhaled CO2 level

Countries

Qatar

Contacts

Primary ContactDr.Nasser Haidar
nhaidar@hamad.qa33888256
Backup ContactDr. Khalid Alansari
kalansari1@hamad.qa55656661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026