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CTRI Number  CTRI/2019/05/019116 [Registered on: 14/05/2019] Trial Registered Prospectively
Last Modified On: 17/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Trial to compare the effectiveness of Chlorhexidine at lower concentrations for Pneumonia development in ventilator assisted patients 
Scientific Title of Study   Effectiveness of oral hygiene with Chlorhexidine mouth wash with different concentration (0.12% and 0.2%) on incidence of VAP; - A Prospective Comparative Randomized Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nagesh Vyas 
Designation  Critical Care Resident 
Affiliation  Apex Hospital  
Address  Apex Hospital, SP-4 & 6, Malviya Nagar Industrial Area, Malviya Nagar, Jaipur, Rajasthan 302017

Jaipur
RAJASTHAN
302017
India 
Phone  9413193294  
Fax    
Email  drnageshpvyas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priya Mathur 
Designation  Head Critical Care 
Affiliation  Apex Hospital  
Address  Department of Critical Care Medicine Apex Hospital Malviya Nagar, Jaipur, Rajsthan

Jaipur
RAJASTHAN
302017
India 
Phone    
Fax    
Email  priyamathur2753855@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nagesh Vyas 
Designation  Critical Care Resident 
Affiliation  Apex Hospital  
Address  Apex Hospital, SP-4 & 6, Malviya Nagar Industrial Area, Malviya Nagar, Jaipur, Rajasthan 302017


RAJASTHAN
302017
India 
Phone  9413193294  
Fax    
Email  drnageshpvyas@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Dr Nagesh Vyas 
Address  Apex Hospital, SP-4 & 6, Malviya Nagar Industrial Area, Malviya Nagar, Jaipur, Rajasthan 302017 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nagesh Vyas  Critical Care Unit  Apex Hospital, Jaipur
Jaipur
RAJASTHAN 		 9413193294

drnageshpvyas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insititutional Ethics Committee Apex Hospitals Pvt. Ltd.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J13||Pneumonia due to Streptococcus pneumoniae,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chlorhexidine mouth wash 0.12%   Chlorhexidine 0.12% will be prepared by diluting 0.2% chlorhexidine (6 ml 0.2% chlorhexidine + 40ml sterile water) Available brand - Hexiclear Mouth Wash ( Ikon remedies Pvt. Ltd.) Cleaning of Oral Cavity with chlorhexidine soaked sterile gauze 3 times a day, A sterile gauze will be soaked in sterile water (15-20cc of sterile water) and any particulate matter from the oropharyngeal area will be rinsed off. A sterile gauze will be soaked in 15 ml of Chlorhxidine mouth wash (0.12%) and used to swab the entire oropharyngeal mucosa, teeth and part of the endotracheal tube inside the oropharyngeal area. 
Comparator Agent  Chlorhxidine mouth wash 0.2%   Available brand - Hexiclear Mouth Wash ( Ikon remedies Pvt. Ltd.) Cleaning of Oral Cavity with chlorhexidine soaked sterile gauze 3 times a day, A sterile gauze will be soaked in sterile water (15-20cc of sterile water) and any particulate matter from the oropharyngeal area will be rinsed off A sterile gauze will be soaked in 15 ml of Chlorhxidine mouth wash (0.2%) and used to swab the entire oropharyngeal mucosa, teeth and part of the endotracheal tube inside the oropharyngeal area.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Male or female patients of age 18 to 75 yrs,

2. Requiring mechanical ventilation for at least more than 72 hours with normal hemodynamics with or without vasopressor
 
 
ExclusionCriteria 
Details  1. Known case pneumonia

2. Development of pneumonia within 48 hours of intubation

3. Chronic Obstructive Lung Disease with active chest infection; patients

4. Patients already received mechanical ventilation for more than 24 hours

5. Patients who have aspirated/with chest x-rays already showing infiltrates

6. Oral mucositis: It may cause local irritation and hypersensitivity.

7. Legal incarceration (e.g., organ transplantation or patients having long-term steroid therapy): They have a chance of hypersensitivity reaction.

8. Patients who died or were discharged within 48 hours of admission in the ICU.

9. Patients receiving immunosuppressive therapy or who were hypersensitive to chlorhexidine gluconate
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of Ventilator associated Pneumonia diagnosed by Endotracheal Secretion culture for P-pneumonia  Every 48 hrs after intubation for incidence of VAP  
 
Secondary Outcome  
Outcome  TimePoints 
Deintubation   Everyday a through clinical examination and check of lab value for deintubation 
Death  Everyday with 3 hour shit, check for vitals  
Discharge from ICU  Everyday when patient is deintubated and discharged from ICU  
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "113"
Final Enrollment numbers achieved (India)="113" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2019 
Date of Study Completion (India) 30/06/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/06/2020 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Background: Mechanical ventilation is often required in critically ill patients, due to various

reasons. Patients on mechanical ventilation are always on risk of developing pneumonia due to

multiple factors. Ventilator associated pneumonia (VAP) occur in 9- 27 % of patients on

mechanical ventilation. Various mouth wash with different concentration are used for oral care to

prevent VAP. Aim of this study was to find out most efficacious concentration of chlorhexidine

mouth wash to prevent VAP.

Materials and methods: The double-blind randomized study included 140 patients in critical

care unit requiring mechanical ventilation for more than 48 hours after obtaining permission

from hospital ethical committee and written informed consent from the attendants, they

randomly allocated in two groups of 70 each. Group I and Group II received oral care with

chlorhexidine 0.12% and chlorhexidine 0.2% respectively. The diagnosis of VAP was made by

using CPIS. A score of ≥6 considered VAP.

Results: In intervention group 7 VAP, 30 discharges, 11 LAMA (Left Against Medical Advice),

8 deaths were reported. On the other hand 2 VAP, 36 discharges, 9 LAMA, 11 deaths were

reported in control group. Comparison of above mentioned indicators analysis data we found

significance difference in VAP incidence but the safety, ICU stay, hospital stay, Days on

ventilator and mortality of both groups is similar. We also found no relation between incidence

of VAP and oral microbial load.

Conclusions: oral hygiene with Chlorhexidine 0.12% is less effective than Chlorhexidine 0.20%

for prevention of VAP in mechanically ventilated patients.

 
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