Condition category
Not Applicable
Date applied
03/06/2018
Date assigned
06/06/2018
Last edited
06/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

Sponsor information

Organisation

Narayana Hrudayalaya Limited

Sponsor details

NH Health City
258/A Bommasandra Industrial Area
Anekal Taluk
Bangalore
560099
India

Sponsor type

Hospital/treatment centre

Website

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

Editorial Notes