An observational study in Diabetes Mellitus, sponsored by Hamad Medical Corporation. Recruiting at 1 site in Qatar. Open to participants aged Up to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Hamad Medical Corporation · Observational
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.
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 150 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hamad Medical Corporation is the lead sponsor of 139 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
known or newly diagnosed diabetics children between the age group of 0- 14 years
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All children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not.
Exclusion Criteria:
Capnography: a continuous wave form of the CO2 level with the digital reading of CO2 level at end of expiration
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.
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2019 (actual). Primary completion is estimated for Dec 2024, 62 months after the start.
Of 109 industry-sponsored observational studies under Diabetes Mellitus, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 39. This study's planned 62 months is above that.
Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.
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