| CTRI Number |
CTRI/2024/07/071216 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative cross sectional study |
| Study Design |
Other |
|
Public Title of Study
|
Adult Patients experiences of mechanical ventilation in an intensive care unit |
|
Scientific Title of Study
|
Adult patients experience to be mechanically ventilated in intensive care unit: a qualitative cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Devi |
| Designation |
Junior resident (PG) |
| Affiliation |
All India Institute of Medical Science , Bathinda |
| Address |
Anaesthesiology Department AIIMS BATHINDA
Bathinda
PUNJAB
151001
India |
| Phone |
6006882940 |
| Fax |
|
| Email |
preetiudh1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Gupta |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bathinda |
| Address |
Anaesthesiology and critical care department of All India Institute of Medical Science,Bathinda,Punjab,151001
Bathinda
PUNJAB
151001
India |
| Phone |
8077754166 |
| Fax |
|
| Email |
drm_gupta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Kanwat |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bathinda |
| Address |
Anaesthesiology and critical care department of All India Institute of Medical Science,Bathinda,Punjab,151001
Bathinda
PUNJAB
151001
India |
| Phone |
6006882940 |
| Fax |
|
| Email |
gopikanwat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and critical care ,Bathinda, Punjab, 151001 India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and critical care ,Bathinda |
| Address |
AIIMS Bathinda |
| 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 Preeti Devi |
All India Institute of Medical Sciences,AIIMS Bathinda |
Department of Anaesthesiology and critical care, All India Institute of Medical Sciences, Bathinda, Punjab
Bathinda
PUNJAB |
6006882940
preetiudh1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Bathinda Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIl |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
mechanically ventilated in an ICU for more than 24 hours
Conscious and oriented
able to discuss feelings |
|
| ExclusionCriteria |
| Details |
hemodynamically unstable |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the experiences of patients who were on mechanical ventilation |
Interviews will be scheduled at a convenient time for 20–40 minutes in their hospital room 3–14 days after the transfer from icu |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To asssess the level of patient satisfaction
To identify unmet needs of Patients |
18 months |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
30/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
After discharging from ICU the Adult patients >18 years who were mechanically ventilated for more than 24 hours will be selected to take interview after obtaining consent to participate in study and meeting the inclusion criteria A semistructured interview guide will be provided to patients participating in an ICU about their experiences of mechanical ventilation in an ICU interview will be voice recorded in a recorder and analyzed using the nvivo software to gain in-depth knowledge about their experiences of mechanical ventilation in an ICU |