Plain English Summary
Background and study aims
The area of the study is an emergency department, with patients presenting to emergency with acute/severe illnesses for example: chest pain (heart attacks), breathing difficulty (lung infections), stoppage of heart (cardiac arrest), brain strokes, poisoning are a few examples.
This study aims to determine whether a handheld arterial blood gas analyser (ABG), which produces results more quickly and is therefore beneficial to an emergency department, is as accurate as the central lab autoanalyzer at measuring sodium (Na+) and Potassium (K+) electrolytes.
Who can participate?
Adults aged above 18 years presenting to the emergency department
What does the study involve?
Eligible participants are treated as per the normal protocols of treatment, this study does not alter their treatment, routine care, hospital stay or outcome in terms of life or death of the participant, as it is just an observational study. Participants have blood samples taken and measured using a handheld arterial blood gas analyser and the central lab autoanalyzer.
What are the possible benefits and risks of participating?
There are no direct benefits or risks for participants in the study.
Where is the study run from?
NH Multispecialty Hospital (India)
When is the study starting and how long is it expected to run for?
April 2016 to November 2017
Who is funding the study?
Narayana Hrudayalaya Limited (India)
Who is the main contact?
Dr Talha Hussain (public)
Trial website
Contact information
Type
Public
Primary contact
Dr Talha Hussain
ORCID ID
http://orcid.org/0000-0002-5469-316X
Contact details
Narayana Hrudulayala Pvt Ltd
NH Health city
Bommasandra
Anekal Taluk
Bangalore
560100
India
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Comparison of the point-of-care blood gas analyzer (ABG) versus the laboratory auto-analyzer (AA) for the measurement of electrolytes (Na+ and K+) in emergency department
Acronym
Study hypothesis
The null hypothesis states that there is no significant difference between electrolytes measured (sodium and potassium) using a handheld arterial blood gas analyzer (ABG) compared to the central lab autoanalyzer.
Ethics approval
Narayana Health Academics Ethics committee, 02/06/2016, ref: NHH/AEC-CL-2016-O57
Study design
A prospective observational cross-sectional cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
See additional files
Condition
Emergency medicine
Intervention
This prospective observational study with a sample size of 200 study is conducted in NH-Multispecialty Hospital, Bangalore, India, in the emergency department. 200 consecutive patients with paired (2) samples of Arterial (1) and Venous (1) blood are included.
The study period is 1 year. The values of sodium (Na+) and potassium (K+) are measured using both a handheld arterial blood gas analyzer (ABG) and the central lab autoanalyzer, and compared using the paired t-test using R software. All results are expressed in mean +/- standard deviation.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Sodium (Na+) and Potassium (K+) levels are measured from blood samples using a handheld arterial blood gas analyzer (ABG) and the central lab autoanalyzer at the time of sample, to compare the accuracy of results.
Secondary outcome measures
None
Overall trial start date
03/04/2016
Overall trial end date
30/11/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age above 18 years of either sex.
2. Patients presenting to ED with:
2.1. Unresponsiveness, with cardiac arrest without brain death
2.2. Hypovolemia
2.3. Patient in any form of shock: Hypovolumeic , Cardiogenic , Distributive , Septic
2.4. Anticipated sepsis and septic shock
2.5. Acute altered mental status
2.6. Acute respiratory distress
2.7. ACS
2.8. Cardiac rhythm disturbances
2.9. Seizures
2.10. CVA
2.11. Symptomatic patient with drug overdose
2.12. Poisoning – unknown compound/known
2.13. Abnormal blood sugar levels RBS < 40 mg% or >250 mg% or high unrecordable/low unrecordable blood sugars, by digital glucometers using capillary finger prick RBS.
2.14. Encephalopathies
2.15. Cardiac failure
2.16. AKI/CKD with acute symptoms
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200 individuals
Participant exclusion criteria
1. Less than 18 years of age
2. Burns patients
Recruitment start date
30/06/2016
Recruitment end date
31/05/2017
Locations
Countries of recruitment
India
Trial participating centre
NH Multispecialty Hospital
No 1, Basanth Healthcare Center
Opposite HSR Club
HSR Layout
Sector 2
Bangalore
560102
India
Funders
Funder type
Hospital/treatment centre
Funder name
Narayana Hrudayalaya Limited
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in International Journal of Emergency Medicine.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Talha Hussain (principal investigator), talh0910@gmail.com
Intention to publish date
01/10/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN11776777_PIS_v1_06Jun18.docx Uploaded 02/04/2019