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

Recruiting

• Conditions: Diabetes Mellitus

• Registration Number: NCT04121572
• Lead Sponsor: Hamad Medical Corporation

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.

Study Timeline

• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-08
• Study Start: 2019-10-10
• Study First Posted: 2019-10-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To utilize capnography as a noninvasive tool for the detection and monitoring of DKA	2 years	Capnography measures exhaled CO2 which is an indicator of the presence and severity of metabolic acidosis caused by DKA.

Secondary Outcome Measures

Name	Time	Method
To find the ability of EtCO2 in ruling in or out DKA	2 years	by 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

Trial Locations

Locations (1)

Hamad Medical Corporation; 🇶🇦 Doha, Qatar