| CTRI Number |
CTRI/2022/01/039607 [Registered on: 20/01/2022] Trial Registered Prospectively |
| Last Modified On: |
19/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Tracheostomy care protocol to prevent tracheostomy complications among patients. |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of Tracheostomy Care Protocol (TCP) for the intensive care nurses to prevent the tracheostomy complications among the adult tracheostomy patients in the selected hospital of Udupi District. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alice Riva Bilung |
| Designation |
Nurse Practitioner in Critical Care |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing, Manipal, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9679562932 |
| Fax |
|
| Email |
aliealice29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Janet Prameela D Souza |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing, Manipal, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986417306 |
| Fax |
|
| Email |
janet.p@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Alice Riva Bilung |
| Designation |
Nurse Practitioner in Critical Care |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing, Manipal, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9679562932 |
| Fax |
|
| Email |
aliealice29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital |
| Manipal College of Nursing |
|
|
Primary Sponsor
|
| Name |
Alice Riva Bilung |
| Address |
Madhav Nagar, Eshwar Nagar, Manipal |
| 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 |
| Alice Riva Bilung |
Kasturba Hospital, Manipal |
Neuro ICU, Surgical ICU, Medical ICU, Multidisciplinary ICU
Udupi
KARNATAKA |
9679562932
aliealice29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nurses working in Intensive care units |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care |
Standard Care |
| Intervention |
Tracheostomy Care Protocol |
To prevent the complication of tracheostomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Intensive care nurses-
Inclusive criteria: nursing staff working in ICU settings of Kasturba Hospital of Manipal, the participants who are available and who are willing to participate in the study during the time of data collection are included for this study.
|
|
| ExclusionCriteria |
| Details |
Exclusive criteria: Nursing students in ICU settings are excluded from this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Improvement in knowledge and practice of tracheostomy care
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in complication rates. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/01/2022 |
| 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
|
Not yet recruiting |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tracheostomy is a frequent performing surgical procedure in ICU settings, the tracheostomy complication rate is vary from country to country, from as low as 2.1% to higher than 20% in some series. There are no standard complication rate related to tracheostomy which makes difficult for tracheostomy complications comparision.The purpose of this study is to bring out standard tracheostomy care protocol (TCP). This TCP will be a simple, easy and creative way to remember the tracheostomy care protocol to prevent the complications and to enhance the quality care for the patients. By this, health care providers may improve their knowledge and there may be prevention of tracheostomy complications such as local wound infections, bleeding, hypoxia, tube obstruction and also it may minimize hospital stay and the patients may recover fast. Aims & objectives: Objectives of the study are to: - Collect three-month data on tracheostomy complications from the selected hospital. (prospectively). - Determine the existing knowledge of tracheostomy care among the intensive care nurses by using a structured knowledge questionnaire. - Determine the existing practice of care by using a practice checklist. - Evaluate the effectiveness of tracheostomy care protocol, in terms of · Improvement in knowledge and practices. · Reduction in complication rates.
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