| CTRI Number |
CTRI/2023/12/060641 [Registered on: 21/12/2023] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of position on LRTI, non randomized control trial |
|
Scientific Title of Study
|
Effectiveness of prone positioning among patient suffering from lower respiratory tract infection (LRTI) admitted at tertiary care hospitals of Gangtok sikkim |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apshara Rai |
| Designation |
Msc nursing student,medical surgical nursing |
| Affiliation |
Indian Nursing council, state nursing council,NAAC |
| Address |
Sikkim manipal college of nursing, 5th mile ,radong gangtok ,sikkim
East
SIKKIM
737102
India |
| Phone |
8688861274 |
| Fax |
|
| Email |
apshararai456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shashirani pangambam |
| Designation |
Associate professor ,medical surgical nursing department |
| Affiliation |
Indian Nursing council, state nursing council,NAAC |
| Address |
Sikkim manipal college of nursing, 5th mile ,tadong gangtok
East
SIKKIM
737102
India |
| Phone |
8967035767 |
| Fax |
|
| Email |
shashirani.p@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Karma Doma Bhutia |
| Designation |
Assistant professor , medical surgical department |
| Affiliation |
Sikkim manipal college of nursing |
| Address |
Sikkim manipal college of nursing, 5th mile ,tadong gangtok
East
SIKKIM
737102
India |
| Phone |
7063305437 |
| Fax |
|
| Email |
karmadoma.b@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Sikkim manipal college of nursing |
|
|
Primary Sponsor
|
| Name |
SMIMS |
| Address |
Sikkim manipal college of nursing,5th mile, gangtok, tadong |
| 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 |
| Apshara Rai |
Central referral hospital and new sir thutob namgyal memorial hospital |
Medical and respiratory ward
East
SIKKIM |
8688861274
apshararai456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sikkim Manipal Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Prone positioning |
I will provide prone positioning for 2 hours/day for 3 consecutive days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who are willing to participate
2. Patient who are diagnosed with LRTI
3. Who can understand, read and write either hindi,nepali and english. |
|
| ExclusionCriteria |
| Details |
1.patient who are in ventilator support |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Prone position will reduce the symptoms of respiratory problems among patients.
2.It will act as cost effective among patients. |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.It will act as cost effective among patients. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/12/2023 |
| 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="15" |
|
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
|
Respiratory problems are the major leading cause of hospitalizations in todays wod. Prone position helps to reduce respiratory symptoms and decreases the need for oxygen therapy among patients. It is not in practice at CRH and STNM So study is done to check the effectiveness of prone positioning among the patients suffering from Lower respiratory tract infections (LRTI).
- To
assess the level of respiratory problem in both control and experimental
group.
- To
determine the effectiveness of prone position on respiratory problem among
patients in both experimental and control group.
- To
determine the association on the level of respiratory problems among
patient receiving prone positioning with demographic variable.
|