| CTRI Number |
CTRI/2022/03/041128 [Registered on: 15/03/2022] Trial Registered Prospectively |
| Last Modified On: |
14/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of oral care with cholrhexidine compared to suction toothbrush on outcome of ICU patients |
|
Scientific Title of Study
|
Effect of oral care protocol with versus without chlorhexidine on mortality of mechanically ventilated patients: prospective randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahil singh |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical college Delhi |
| Address |
Room no. 413 BL Taneja block Maulana Azad Medical College Delhi 110002
Central
DELHI
110002
India |
| Phone |
9810719025 |
| Fax |
|
| Email |
drrahilsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahil singh |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical college Delhi |
| Address |
Room no. 413 BL Taneja block Maulana Azad Medical College Delhi 110002
Room no. 413 BL Taneja block Maulana Azad Medical College Delhi 110002
Central
DELHI
110002
India |
| Phone |
9810719025 |
| Fax |
|
| Email |
drrahilsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahil singh |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical college Delhi |
| Address |
Room no. 413 BL Taneja block Maulana Azad Medical College Delhi
Room no. 413 BL Taneja block Maulana Azad Medical College Delhi 110002
Central
DELHI
110002
India |
| Phone |
9810719025 |
| Fax |
|
| Email |
drrahilsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, JLN Marg , New Delhi-02 |
|
|
Primary Sponsor
|
| Name |
Lok Nayak Hospital Jawaharlal Nehru Marg Near Delhi Gate New Delhi D |
| Address |
Intensive Care Unit, fourth floor, Lok Nayak Hospital New Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Rahil Singh |
Lok Nayak Hospital |
Intensive Care Unit, fourth floor, Lok Nayak Hospital, New Delhi 110002
Central
DELHI |
9810719025
drrahilsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
oral care with chlorhexidine gluconate solution |
Oral hygiene will be maintained using 0.12% chlorhexidine gluconate solutions soaked in a sterile gauze piece |
| Intervention |
oral care with suction toothbrush in mechanically ventilated patients |
Using a suction toothbrush having
ultrasound bristle and a toothpaste ,the teeth of patient will be cleaned. The teeth will be cleaned in quadrants and all teeth surfaces will be cleaned for 2 full minutes. After cleaning the teeth, rinsing of oral cavity with sterile water dispensed via a syringe and continual aspiration will be done to remove debris |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients receiving invasive mechanical ventilation for more than 48 hours |
|
| ExclusionCriteria |
| Details |
1. Pulmonary infection at the time of ICU admission
2.Edentulous patients
3.Intraoral surgery or trauma
4. Pregnant patients
5. Chlorhexidine allergy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient outcome (all cause mortality) |
5,10 and 15 days after randomization into study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Occurence of ventilator associated pneumonia |
5, 10, 15 days after randomization of grooups |
| Oral health using BOAS scale and plaque index |
5, 10 and 15 days after randomization |
| Number of days spent on mechanical ventilation |
5, 10 and 15 days after randomization |
| APACHE II Score |
5, 10 and 15 days after randomization |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
24/03/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable yet |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drrahilsingh@gmail.com].
- For how long will this data be available start date provided 24-12-2023 and end date provided 24-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In this study , we aim to assess the effects of oral care protocol using a suction tooth brush for oral care in mechanically ventilated patients and compare this with 0.12% chlorhexidine solution .A total of 154 patients will be recruited for participation in study and they will be randomized into two groups. As per group allocation either suction toothbrush or chlorhexidine will be used for oral care in mechanically ventilated patients.In both the groups other oral care elements such as assessment of oral hygiene, suctioning of oropharyngeal secretions, application of lip and mouth moisturization will be followed. We will be assessing study groups in terms of mortality rate, incidence of VAP ,oral health status |