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

NCT04121572 | Recruiting

• 1 other identifier: MRC-01-17-103
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetic ketoacidosis; End tidal carbon dioxide; Capnography

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• To find the ability of EtCO2 in ruling in or out DKA

  2 years

Other Outcomes (1)

• To evaluate the different severity grades of DKA using EtCO2 Monitoring

  2years

Interventions

Nasal cannula capnography DEVICE

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

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

known or newly diagnosed diabetics children between the age group of 0- 14 years

You may qualify if:

• All children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Ketosis; Acidosis; Acid-Base Imbalance; Diabetes Complications

Study Officials

• Dr. Khalid Alansari

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Nasser Haidar

CONTACT

33888256; nhaidar@hamad.qa

Dr. Khalid Alansari

CONTACT

55656661; kalansari1@hamad.qa

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatric Emergency Center's

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: October 10, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

QA (1)