| CTRI Number |
CTRI/2023/05/053190 [Registered on: 29/05/2023] Trial Registered Prospectively |
| Last Modified On: |
24/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Knowledge of abnormal electrocardiogram and managing the cardiac monitor by nursing staff. |
|
Scientific Title of Study
|
A cluster randomized controlled trial to assess knowledge and to evaluate the effectiveness of structured training program regarding interpretation of life threatening arrhythmias, its emergency and alarm protocol among critical care nurses of Ranchi district Jharkhand. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sweta kumari |
| Designation |
PhD Scholar/ Staff Nurse |
| Affiliation |
Central Coalfield Limited Ranchi |
| Address |
Office of matron incharge. Room no 08, Department of Nursing. Gandhi nagar hospital. Gandhinagar colony. Kanke road Ranchi.
Office of Matron in charge. Room no 08, Department of Nursing. Gandhinagr hospital. Gandhinagar colony. Kanke road Ranchi.
Pin 834008
Ranchi
JHARKHAND
834008
India |
| Phone |
8210627207 |
| Fax |
|
| Email |
swetakumariccl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Litna George |
| Designation |
Assistant Professor, Department of Nursing |
| Affiliation |
Rajendra Institute of Medical sciences Ranchi |
| Address |
Room no 02, Nursing College.Rajendra Institute of Medical Science .Bariatu. Ranchi
College of nursing RIMS Ranchi.
Ranchi
JHARKHAND
834002
India |
| Phone |
8521795430 |
| Fax |
|
| Email |
Litna.george@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sweta kumari |
| Designation |
PhD Scholar |
| Affiliation |
Rajendra Institute of Medical sciences Ranchi |
| Address |
Nursing college. Department of Medical Surgical Nursing.Room no 02, Rajendra institute of Medical Science Ranchi.Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
8210627207 |
| Fax |
|
| Email |
swetakumariccl@gmail.com |
|
|
Source of Monetary or Material Support
|
| This trail is not getting any monetary support. It is self funded project.This study will be conducted at Rajendra Institute of Medical Science hospitals. |
|
|
Primary Sponsor
|
| Name |
Sweta Kumari |
| Address |
PhD Scholar. Rajendra Institute Of Medical Sciences.Ranchi.Jharkhand. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sweta Kumari |
Rajendra Institute of Medical Science hospitals , Ranchi ,Jharkhand . |
All Critical Care setting (ICU/ CCU) of the hospital.
Ranchi
JHARKHAND |
8210627207
swetakumariccl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Rajendra Institute of Medical Science,Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Critical care nurses will be the participants. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
No training will be given to to the comparison arm |
| Intervention |
Structured training program |
A teaching module will be prepared by the researcher. A cardiac alarm protocol will be developed by the researcher. After the validation of the teaching module and alarm protocol, critical care nurses will be assessed by using a knowledge questionnaire and alarm protocol checklist, prepared by the researcher. Nurses will be assessed for their knowledge of emergency arrhythmia interpretation, its management, and cardiac alarm protocol. Training will be provided for 01 day to selected critical care nurses for a full day. Post-training assessment of the same group will be done after 01 months, using the same questionnaire and checklist. The duration of intervention will be 01 day 04 hours training program. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Staff nurses working in critical care units of selected hospitals. |
|
| ExclusionCriteria |
| Details |
Critical care nurses not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increased knowledge of critical care nurses by 20 % about emergency arrhythmia interpretation, its management, and alarm protocol. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduced nuisance monitor alarm
Improved critical care patient safety |
1 month |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A cluster randomized controlled trial is planned to increase the efficiency if critical care nurses regarding emergency ECG interpretation, and its management. critical care nurses will be also efficient to manage the nuisance alarm after the completion of this study, hence they will reduce the mortality and mortality of critical care patients. |