EtCO2 for Monitoring and Predicting Severity of DKA in Pediatric Emergency, Doha, Qatar.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04121572|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Device: Nasal cannula capnography|
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 Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||EtCO2 for Monitoring and Predicting Severity of DKA in Pediatric Emergency, Doha, Qatar.|
|Actual Study Start Date :||October 10, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 30, 2021|
- Device: Nasal cannula capnography
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 [ Time Frame: 2 years ]Capnography measures exhaled CO2 which is an indicator of the presence and severity of metabolic acidosis caused by DKA.
- To find the ability of EtCO2 in ruling in or out DKA [ Time Frame: 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
- To evaluate the different severity grades of DKA using EtCO2 Monitoring [ Time Frame: 2years ]by correlating the severity of DKA based on the bicarbonate level to the exhaled CO2 level
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121572
|Contact: Dr.Nasser Haidarfirstname.lastname@example.org|
|Contact: Dr. Khalid Alansariemail@example.com|
|Hamad Medical Corporation||Recruiting|
|Doha, Qatar, 3050|
|Contact: Dr.Khalid Alansari 55656661 firstname.lastname@example.org|
|Principal Investigator:||Dr. Khalid Alansari||Hamad Medical Corporation|