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

NCT ID: NCT04121572

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-10

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Diabetes Mellitus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Nasal cannula capnography

Capnography: a continuous wave form of the CO2 level with the digital reading of CO2 level at end of expiration

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hamad Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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DR. KHALID AL-ANSARI

Director of Pediatric Emergency Center's

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Khalid Alansari

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

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Hamad Medical Corporation

Doha, , Qatar

Site Status RECRUITING

Countries

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Qatar

Central Contacts

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Dr.Nasser Haidar

Role: CONTACT

Dr. Khalid Alansari

Role: CONTACT

Facility Contacts

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Dr.Khalid Alansari

Role: primary

Other Identifiers

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MRC-01-17-103

Identifier Type: -

Identifier Source: org_study_id

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