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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
Sponsor:
Information provided by (Responsible Party):
DR. KHALID AL-ANSARI, 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.

Condition or disease Intervention/treatment
Diabetes Mellitus Device: Nasal cannula capnography

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

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


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
known or newly diagnosed diabetics children between the age group of 0- 14 years
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

Information from the National Library of Medicine

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


Contacts
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Contact: Dr.Nasser Haidar 33888256 nhaidar@hamad.qa
Contact: Dr. Khalid Alansari 55656661 kalansari1@hamad.qa

Locations
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Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar, 3050
Contact: Dr.Khalid Alansari    55656661    kalansari1@hamad.qa   
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Principal Investigator: Dr. Khalid Alansari Hamad Medical Corporation

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Responsible Party: DR. KHALID AL-ANSARI, Director of Pediatric Emergency Center's, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT04121572    
Other Study ID Numbers: MRC-01-17-103
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DR. KHALID AL-ANSARI, Hamad Medical Corporation:
Diabetic ketoacidosis
End tidal carbon dioxide
Capnography
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes