| CTRI Number |
CTRI/2024/04/066224 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assess the nursing practices for care of patients on ventilator admitted in ICU |
|
Scientific Title of Study
|
A study to assess the nursing practices for care of patients on ventilator admitted in ICU of tertiary care hospital with a view to develop standard nursing care protocol for ventilator patients |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Urvashi |
| Designation |
MSc Nursing Student (Critical Care) |
| Affiliation |
|
| Address |
PORTA CABIN 2, College of Nursing, ALL INDIA INSTITUTE MEDICAL SCIENCE, AnsariI Nagar, New Delhi-110029
South West
DELHI
110029
India |
| Phone |
9868522929 |
| Fax |
|
| Email |
urvashidadwal27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shashi Mawar |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
2nd Floor,Room no. 1, next to Porta Cabin 1, College of Nursing, ALL INDIA INSTITUTE MEDICAL SCIENCE, AnsariI Nagar, New Delhi-110029
South West
DELHI
110029
India |
| Phone |
880228317 |
| Fax |
|
| Email |
urvashidadwal27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shashi Mawar |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
2nd Floor,Room no. 1, next to Porta Cabin 1, College of Nursing, ALL INDIA INSTITUTE MEDICAL SCIENCE, AnsariI Nagar, New Delhi-110029
DELHI
110029
India |
| Phone |
880228317 |
| Fax |
|
| Email |
urvashidadwal27@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing, AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
College of Nursing ALL INDIA INSTITUTE MEDICAL SCIENCE |
| Address |
College of Nursing, ALL INDIA INSTITUTE MEDICAL SCIENCE, Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Dalim Kumar Baidya |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE NEW DELHI |
AB8 ICU, 8 TH FLOOR, MAIN BUILDING, All INDIA INSTITUTE OF MEDICAL SCIENCE NEW DELHI
South West
DELHI |
9868522929
urvashidadwal27@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTE FOR POST GRADUATE RESEARCH, AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
OBSERVATION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
A complete enumeration of all the possible elements within the set of interest will be taken.
Age below 25 to above 35 |
|
| ExclusionCriteria |
| Details |
The nurses who will be on leave during the data collection period. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop standard nursing care protocol for ventilator patients |
1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NIl |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nurses are the most important healthcare team members
in providing holistic care. Making nurses responsible for mechanically
ventilated patient care is important because their activities revolve around
patients, besides they are consistently in contact with patients & hence
sensitive to the gap between ever-changing needs & the actual care
received, & therefore better placed care according to patients. Most of the
books mentioned the care of patients on mechanical ventilation, which is
practiced around India according to their convenience because no standard
nursing care protocol exists.
Many times,
recommendations to prevent mechanical ventilation difficulties are not strictly
implemented. As a result, the goal of this study is to see if nurses improve
the level of care for patients on mechanical ventilation. As part of
current procedures, patients are given DVT prophylaxis, their performance in
airway care is assessed, regular suctioning and they receive oral care with 2%
chlorhexidine every eight hours.
Moreover, to
the best of the researcher’s knowledge, there are no available protocols or
standards of care for mechanically ventilated patients in the study setting.
Therefore,
the researcher aims to develop a standard nursing care protocol to assess the
nursing care practices for the patients on ventilator admitted to ICU.
|