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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04121572
• Other study ID #: MRC-01-17-103
• Status: Recruiting
• Start date: October 10, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Hamad Medical Corporation
• Contact: Dr.Nasser Haidar
• Phone: 33888256
• Email: nhaidar[@]hamad.qa
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Emergencies

Intervention

Device:
• Nasal cannula capnography
Capnography: a continuous wave form of the CO2 level with the digital reading of CO2 level at end of expiration

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate the different severity grades of DKA using EtCO2 Monitoring	by correlating the severity of DKA based on the bicarbonate level to the exhaled CO2 level	2years
Primary	To utilize capnography as a noninvasive tool for the detection and monitoring of DKA	Capnography measures exhaled CO2 which is an indicator of the presence and severity of metabolic acidosis caused by DKA.	2 years
Secondary	To find the ability of EtCO2 in ruling in or out DKA	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	2 years