| CTRI Number |
CTRI/2021/07/034923 [Registered on: 16/07/2021] Trial Registered Prospectively |
| Last Modified On: |
10/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Active Controlled Trial |
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Public Title of Study
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A study to develop and implement protocol related to medicine by inhalation giving after removal of lung supportive tube and effectiveness will assess by childs health status nurses knowledge and practice |
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Scientific Title of Study
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A study to develop and assess the effect of implementation of post-extubation nebulization protocol on selected patient care outcomes in pediatric patients and nurse’s knowledge and practice about post-extubation nebulization for pediatric patients admitted in CTVS, ICU
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANISHA MANNA |
| Designation |
Student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College of Nursing, AIIMS, New Delhi
Hostel-15, AIIMS, New Delhi
Pin- 110049
South
DELHI
110029
India |
| Phone |
8250784530 |
| Fax |
|
| Email |
anishamanna1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Gopichandran |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College of Nursing, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8130930287 |
| Fax |
|
| Email |
pravigopi@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
ANISHA MANNA |
| Designation |
Student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College of Nursing, AIIMS, New Delhi
Hostel-15, AIIMS, New Delhi
Pin-110049
South
DELHI
110029
India |
| Phone |
8250784530 |
| Fax |
|
| Email |
anishamanna1998@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
ANISHA MANNA |
| Address |
College of Nursing, AIIMS, New Delhi |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ANISHA MANNA |
AIIMS, New Delhi |
CTVS-ICU, 1ST FLOOR, CARDIO-NEURO TOWER, AIIMS, NEW DELHI,
Pin-110029
South
DELHI |
8250784530
anishamanna1998@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Control group |
Control group will be receiving routine care |
| Intervention |
Post-extubation nebulization protocol develop and implementation |
Develop and assess the effect of post-extubation nebulization protocol on selected patient care outcome and assess the nurses knowledge and practice of post-extubation nebulization procedure beofore and after implementation of post-extubation nebulization protocol |
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Inclusion Criteria
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| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
For nurses:
• Grade II Nursing officers who are willing to participate in the study.
• Nurses present at the time of entire study.
• Nurses who are involved in direct patient care in CTVS-ICU of AIIMS, New Delhi.
For patients:
• Age of the patient should be < 12 years
• Patients admitted in CTVS-ICU of AIIMS, New Delhi after elective cardio-thoracic surgery.
• Risk Adjustment for Congenital Heart Surgery (RACHS-1) score 2
|
|
| ExclusionCriteria |
| Details |
For nurses:
• Nurses who are not involve in direct patient care in CTVS-ICU of AIIMS, New Delhi.
• Nurses who do not give consent for taking part in study.
For patients:
• Pediatric patients have undergone in cardio-thoracic surgery in emergency situation
• Pediatric patients who have a history of respiratory disorders
• Pediatric patients who have other genetic disorders
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Arterial oxygen saturation |
At least twice in a day upto 4 days of post-extubation nebulization and at the point of shifting from ICU to stepdown wards |
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Secondary Outcome
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| Outcome |
TimePoints |
Respiratory status: Respiratory rate, heart rate, inspiratory & expiratory ratio, wheezing, use of accessory muscle, breathing pattern, ABG value, chest-X ray
Treatment failure
early shifting from ICU to stepdown wards |
At least twice in a day upto 4 days of post-extubation nebulization and at the point of shifting from ICU to stepdown wards |
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2021 |
| 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="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
H1: There will be a significant difference in the selected patient outcome before and after the implementation of post-extubation nebulization protocol as measured by self-developed questionnaire (p<0.05) H2: There will be a significant difference in the level of knowledge and practice of nurses before and after the implementation of post-extubation nebulization protocol as measured by self-developed questionnaire and checklist (p<0.05)
For the partial fulfillment of post-graduate course |