Clinical trial NCT04121572: EtCO2 for Monitoring and Predicting Severity of DKA in Pediatric Emergency, Doha, Qatar.
Official title: EtCO2 for Monitoring and Predicting Severity of DKA in Pediatric Emergency, Doha, Qatar.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Keywords: Diabetic ketoacidosis
End tidal carbon dioxide
Capnography
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 150
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: known or newly diagnosed diabetics children between the age group of 0- 14 years

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.

Eligibility criteria: 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

Primary outcomes:
measure: To utilize capnography as a noninvasive tool for the detection and monitoring of DKA
timeFrame: 2 years
Secondary outcomes:
measure: To find the ability of EtCO2 in ruling in or out DKA
timeFrame: 2 years
Other outcomes:
measure: To evaluate the different severity grades of DKA using EtCO2 Monitoring
timeFrame: 2years
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Hamad Medical Corporation
name: Dr. Khalid Alansari
role: PRINCIPAL_INVESTIGATOR
References: