To compare the sodium and potassium values on a simple, faster handheld device with that of a central lab machine -which is time-consuming, to identify any abnormal values and decide on quick treatment on patients coming to the emergency department
| ISRCTN | ISRCTN11776777 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11776777 |
| Secondary identifying numbers | 1 |
- Submission date
- 03/06/2018
- Registration date
- 06/06/2018
- Last edited
- 02/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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)
Contact information
Public
Narayana Hrudulayala Pvt Ltd
NH Health city
Bommasandra
Anekal Taluk
Bangalore
560100
India
 ORCID ID |
0000-0002-5469-316X |
|---|
Study information
| Study design | A prospective observational cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN11776777_PIS_v1_06Jun18.docx |
| 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 |
| Study objectives | 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(s) | Narayana Health Academics Ethics committee, 02/06/2016, ref: NHH/AEC-CL-2016-O57 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 03/04/2016 |
| Completion date | 30/11/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 individuals |
| Key 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 |
| Key exclusion criteria | 1. Less than 18 years of age 2. Burns patients |
| Date of first enrolment | 30/06/2016 |
| Date of final enrolment | 31/05/2017 |
Locations
Countries of recruitment
- India
Study participating centre
Opposite HSR Club
HSR Layout
Sector 2
Bangalore
560102
India
Sponsor information
Hospital/treatment centre
NH Health City
258/A Bommasandra Industrial Area
Anekal Taluk
Bangalore
560099
India
"ROR" |
https://ror.org/05kx1ke03 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/10/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in International Journal of Emergency Medicine. |
| IPD sharing plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1 | 06/06/2018 | 02/04/2019 | No | Yes |
Additional files
- ISRCTN11776777_PIS_v1_06Jun18.docx
- Uploaded 02/04/2019
Editorial Notes
02/04/2019: The participant information sheet has been uploaded.
