Diabetes MellitusNCT04121572
EtCO2 for Monitoring and Predicting Severity of DKA in Pediatric Emergency, Doha, Qatar.
An observational study of Diabetes Mellitus, run by Hamad Medical Corporation at 1 site in Qatar.
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. Read more about this study
- Who is it for?
- Ages Up to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Nasal cannula capnography
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteQatar
- Study dates
- 10 Oct 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: known or newly diagnosed diabetics children between the age group of 0- 14 years
Who may be able to join
- All children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not.
Who cannot join
- Older than 14 years of age
- Airway obstruction
- Chest infection
- Complex congenital heart disease
- Congestive heart failure
- Central or peripheral neurological disorders
- Hyper/hypothermia
- Severe pain
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha, 3050
Dr.Khalid Alansari, 55656661, kalansari1@hamad.qa
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Nasal cannula capnography
- Keywords
- Diabetic ketoacidosis, End tidal carbon dioxide, Capnography
- Medical subject headings
- Diabetes Mellitus, Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal cannula capnographyDevice
Capnography: a continuous wave form of the CO2 level with the digital reading of CO2 level at end of expiration
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start10 Oct 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, DR. KHALID AL-ANSARI, Hamad Medical Corporation
- Investigators
- Dr. Khalid Alansari, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121572
- Sponsor's protocol ID
- MRC-01-17-103
- Status last verified
- Feb 2024
- First submitted
- 8 Oct 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EtCO2 for Monitoring and Predicting Severity of DKA in Pediatric Emergency, Doha, Qatar.
- ClinicalTrials.gov ID
- NCT04121572
- Acronym / sponsor ID
- MRC-01-17-103
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetic ketoacidosis, End tidal carbon dioxide, Capnography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- known or newly diagnosed diabetics children between the age group of 0- 14 years
Key inclusion criteria (1 listed)
- All children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not.
Key exclusion criteria (8 listed)
- Older than 14 years of age
- Airway obstruction
- Chest infection
- Complex congenital heart disease
- Congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal cannula capnographyCapnography: a continuous wave form of the CO2 level with the digital reading of CO2 level at end of expiration | Device | – |
Primary outcome
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.
1 secondary outcome
To find the ability of EtCO2 in ruling in or out DKA
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Khalid Alansari principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr.Nasser Haidar (33888256, nhaidar@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To utilize capnography as a noninvasive tool for the detection and monitoring of DKA (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.