| CTRI Number |
CTRI/2021/06/034143 [Registered on: 10/06/2021] Trial Registered Prospectively |
| Last Modified On: |
09/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the efficacy of swallowing exercises on dysphagia among post extubated patients admitted in ICU |
|
Scientific Title of Study
|
Randomized control trial to assess the efficacy of swallowing exercises on dysphagia among postextubated patients admitted in AB8 ICU of AIIMS, Delhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
POOJA MISHRA |
| Designation |
MSC. NURSING |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA |
| Address |
MSc Nursing Critical Care Unit College of Nursing AIIMS New Delhi Ansari Nagar New Delhi
Room No 103 Hostel No. 15 Medha Hostel Masjid Modh AIIMS New Delhi Ansari Nagar Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9310176182 |
| Fax |
9650972404 |
| Email |
poojapragatimishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashi Mawar |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA |
| Address |
College of Nursing
2nd Floor Room No 2 Pota Cabin AIIMS NEW DELHI Ansari Nagar Delhi 110029
College of Nursing
2nd Floor Room No 2 Pota Cabin AIIMS NEW DELHI Ansari Nagar Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8800228317 |
| Fax |
|
| Email |
drshashimawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashi Mawar |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA |
| Address |
College of Nursing
2nd Floor Room No 2 Pota Cabin AIIMS NEW DELHI Ansari Nagar Delhi 110029
College of Nursing
2nd Floor Room No 2 Pota Cabin AIIMS NEW DELHI Ansari Nagar Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8800228317 |
| Fax |
|
| Email |
drshashimawar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
POOJA MISHRA |
| Address |
HOSTEL NO 15 COLLEGE OF NURSING AIIMS NEW DELHI |
| Type of Sponsor |
Other [MSC NURSING STUDENT] |
|
|
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 Thilika Muthiah |
AIIMS HOSPITAL, NEW DELHI |
AB8 ICU Surgical Department AIIMS New Delhi
New Delhi
DELHI |
9551104526
thilaks84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OFFICE AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
standard care for post extubated patient |
standard care as per hospital protocol |
| Intervention |
Swallowing exercises on dysphagia among post extubated patient |
Swallowing exercises will be done by experimental group
1 Effortful swallow exercise will help to strengthen throat muscles and will be repeated 5 to 10 times 3 times per day on day1, 2 and 3
2 Masako Technique will also help to strength throat muscles and will be repeated 5 to 10 times 3 times per day on day1,2 and 3.
3 Range of motion exercise will help to stretch tongue muscles and will be repeated 5 to times 3 times per day on day1,2 and 3.
4. Supraglotic swallow exercise will be repeated 5 to 10 times on day1,2 and 3. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient extubated after at least 48 hours of intubation
Patient who will be in ICU for 12 hrs post extubation or will undergo water swallow test within 6-12 hrs of extubation
Patient who is conscious and can obey commands
Postextubation at least hospitalized for 2 days after extubation
Patient willing to participate and having difficulty in swallowing
|
|
| ExclusionCriteria |
| Details |
patient who had been extubated and do not have dysphagia.
patient under chemotherapy and radiotherapy. |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in dysphagia |
36 hours and 72 hours post extuabtion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • swallowing function will be assessed and compared among post extubated patients in experimental and control group. |
36 hours and 72 hours |
|
|
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)
|
15/06/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
will be published after data collection and analysis |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Randomized Control Trial to assess the efficacy of
swallowing exercises on dysphagia among postextubated patients admitted in ICU
of AIIMS, New Delhi. objectives · To evaluate the efficacy of swallowing exercises on dysphagia among extubated patient admitted in AB8 ICU. · To assess and compare the swallowing function among extubated patients in experimental and control group HYPOTHESIS H1 There will be a significant difference in swallowing due to dysphagia among experimental group after practicing swallowing exercises as assessed by water swallowing test at p<0.05 level of significance H0 There will be no difference in swallowing due to dysphagia among experimental group after practicing swallowing exercises as assessed by water swallowing test at p<0.05 level of significance
METHODS · · Randomized Control Trial will be undertaken to assess the effectiveness of swallowing exercises among extubated patients with dysphagia. the setting is ICU of AIIMS, New Delhi. adult patients extubated after 48 hrs of intubation will be included. data will be collected in may 2021 and anlaysed using both descritpive and inferential statistics. · · ·
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