| CTRI Number |
CTRI/2024/02/062201 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study comparing the oral care with chlorhexidine is better when compared with multicomponent bundle without chlorhexidine in ventilation patients for prevention of pneumonia. |
|
Scientific Title of Study
|
A Comparative Study To Find Out The Efficacy Of Oral Care With Chlorhedinine Versus Multicomponent Bundle Without Chlorhexidine In Mechanical Ventilated Patients In Intensive Care Unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anushapreethi S |
| Designation |
DM Resident |
| Affiliation |
IMS AND SUM HOSPITAL, BHUBANESWAR |
| Address |
IMS AND SUM HOSPITAL
SIKSHA O ANUSANDHAN (DEEMED TO BE UNIVERSITY)
K-8, Kalinga Nagar,
Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
7500340205 |
| Fax |
|
| Email |
anushapreethi87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Kumar Patnaik |
| Designation |
Associate Professor |
| Affiliation |
IMS AND SUM HOSPITAL, BHUBANESWAR |
| Address |
IMS AND SUM HOSPITAL
SIKSHA O ANUSANDHAN (DEEMED TO BE UNIVERSITY)
K-8, Kalinga Nagar,
Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9833116430 |
| Fax |
|
| Email |
Rohitpatnaik09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Kumar Patnaik |
| Designation |
Associate Professor |
| Affiliation |
IMS AND SUM HOSPITAL, BHUBANESWAR |
| Address |
IMS AND SUM HOSPITAL
SIKSHA O ANUSANDHAN (DEEMED TO BE UNIVERSITY)
K-8, Kalinga Nagar,
Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9833116430 |
| Fax |
|
| Email |
Rohitpatnaik09@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS AND SUM HOSPITAL
SIKSHA O ANUSANDHAN (DEEMED TO BE UNIVERSITY)
K-8, Kalinga Nagar,
Bhubaneswar, Odisha |
|
|
Primary Sponsor
|
| Name |
Anushapreethi S |
| Address |
IMS AND SUM HOSPITAL,
SIKSHA O ANUSANDHAN (DEEMED TO BE UNIVERSITY)
K-8, Kalinga Nagar,
Bhubaneswar, Odisha |
| 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 |
| Dr Anushapreethi S |
INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL |
Department of Critical Care Medicine, MICU AND EXTENSION CCM ICUs, K-8, Kalinga Nagar,
Bhubaneswar, Odisha
Khordha
ORISSA |
7500340205
anushapreethi87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute Of Medical Sciences (IMS) And SUM Hospital |
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 |
| Intervention |
CHLORHEXIDINE GROUP |
the intervention group will be given oral care with multicomponent care bundle includes 0.20% chlorhexidine solution 5-10ml orally, every 12 hrly and tooth brushing, oral suctioning and mouth/lip moisturization |
| Comparator Agent |
WITHOUT CHLORHEXIDINE GROUP |
The control group will be given toothbrushing, oral suctioning and mouth/lip moisturization without chlorhexidine care 12 hrly. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Admitted to the ICU and requiring mechanical ventilation.
2. Anticipated to require mechanical ventilation for more than 48 hours.
3. Patient or legal representative has provided informed consent.
|
|
| ExclusionCriteria |
| Details |
 Patients with known hypersensitivity or allergy to Chlorhexidine.
 Patients already in another oral care study.
 Patients with severe oral trauma or recent oral surgery.
 Patients with a life expectancy of less than 48hrs
Patients for whom oral care maybe contraindicated due to specific medical conditions. (e.g. certain types of oral cancer, certain neurological conditions affecting swallowing).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of IVACs between control and intervention groups during ventilator days. |
6 weeks of ICU stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate 1.oral health status dysfunction measured using BOAS Beck oral assessment score
2.CPOT Critical care pain observation,
3. ventilator days,
4. ICU stay,
5. 28 day mortality,
6. VAP incidence
|
till 5 weeks |
|
|
Target Sample Size
|
Total Sample Size="1286"
Sample Size from India="1286"
Final Enrollment numbers achieved (Total)= "1036"
Final Enrollment numbers achieved (India)="1036" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2024 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - email contact anushapreethi87@gmail.com
- For how long will this data be available start date provided 09-11-2023 and end date provided 09-07-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
*
All
the patients above 18yrs admitting to six ICUs will be screened for our study,
*
Submitted
to intubation, expected to remain on mechanical ventilation for more than 48
hrs.
*
ICU
protocol for oral care without chlorhexidine will be standardized (TABLE 2)
*
After
enrollment, the intervention group will be given oral care with multicomponent
care bundle includes 0.20% chlorhexidine solution every 12 hrly and tooth
brushing, oral suctioning and mouth/lip moisturization (TABLE 1) versus
*
The
control group will be given toothbrushing, oral suctioning and mouth/lip
moisturization without chlorhexidine care.
*
Demographic
characteristics including age, sex will be noted on admission.
*
The
participants also will undergo the standard protocol for prevention of VAP,
which included
*
1.
Maintaining a semirecumbent body position, with head elevation of ≥ 30°,
*
2.
Gastrointestinal bleeding prophylaxis,
*
3.
Deep venous thrombosis prophylaxis and
*
4.
Daily interruption of sedation with assessing the possibility of extubation
PRIMAZRY OBJECTIVE- To
evaluate the time to IVACs between control and intervention groups.
SECONDARY OBJECTIVE-
*
To evaluate 1.oral health status dysfunction
measured using BOAS Beck oral assessment score
*
2.CPOT Critical care pain
observation,
*
3. ventilator days,
*
4. ICU stay,
*
5. 28 day mortality,
*
6. VAP incidence
*
Continued
until the patient is extubated or tracheotomised or died
|