Clinical Trial to compare the effectiveness of Chlorhexidine at lower concentrations for Pneumonia development in ventilator assisted patients

Completed

• Conditions: Pneumonia due to Streptococcus pneumoniae,

• Registration Number: CTRI/2019/05/019116
• Lead Sponsor: Dr Nagesh Vyas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-15
• Study Completion: 2020-06-30
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Oral mucositis: It may cause local irritation and hypersensitivity.
• Legal incarceration (e.g., organ transplantation or patients having long-term steroid therapy): They have a chance of hypersensitivity reaction.
• Patients who died or were discharged within 48 hours of admission in the ICU.
• Patients receiving immunosuppressive therapy or who were hypersensitive to chlorhexidine gluconate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Ventilator associated Pneumonia diagnosed by Endotracheal Secretion culture for P-pneumonia	Every 48 hrs after intubation for incidence of VAP

Secondary Outcome Measures

Name	Time	Method
Deintubation	Everyday a through clinical examination and check of lab value for deintubation
Discharge from ICU	Everyday when patient is deintubated and discharged from ICU
Death	Everyday with 3 hour shit, check for vitals

Trial Locations

Locations (1)

Critical Care Unit; 🇮🇳 Jaipur, RAJASTHAN, India

Critical Care Unit

🇮🇳Jaipur, RAJASTHAN, India

Dr Nagesh Vyas

Principal investigator

9413193294

drnageshpvyas@gmail.com