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A study to analyse effect of oral care with three percentage salt water on the incidence of pneumonia due to ventilator in hospital setup in India

Effect of oral care with 3 percentage Normal saline on the incidence of VAP in a tertiary healthcare set-up in India A randomized controlled double blinded trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/098003
Enrollment
110
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J168- Pneumonia due to other specified infectious organisms

Interventions

Intervention1: Oral care with 3% NORMAL SALINE: In Group B (3% normal saline) oral hygiene will be performed using 3% normal saline solutions 10 ml with Respi-clean oral brush. The teeth will be clean

Sponsors

Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients more than or equal to 18 years of age; receiving invasive mechanical ventilation (MV) with an expected duration of MV more than 7 days and modified CPIS less than 6 as well as previously admitted patients with endotracheal or tracheostomy with modified CPIS less than 6 for at least 5 days will be recruited in the trial.

Exclusion criteria

Exclusion criteria: Already recruited patients. Patients with diagnosed or suspected VAP on admission, who have undergone intraoral surgery; who denied consent, pregnant patients and patients with known chlorhexidine allergy will be excluded

Design outcomes

Primary

MeasureTime frame
Compare the incidence of VAP between patients receiving oral care with 0.2% chlorhexidine versus those receiving oral care with 3% normal saline during 14 days period.Timepoint: during 14 days period after initiating oral care.

Secondary

MeasureTime frame
1. Compare the effect on colonizers of oral secretions between patients receiving oral care with 0.2% chlorhexidine versus those receiving oral care with 3% normal saline during 14 days period.Timepoint: during 14 days period after initiating oral care;To compare the shift in microbiome in patients with VAP in both groups.Timepoint: during 14 days period after initiating oral care.;Compare the 28 days mortality between the two groups.Timepoint: at 28 days after initiating oral care.;Compare the duration of ventilation free days between the groups.Timepoint: till discharge/death;Compare the change of antibiotic for respiratory cause between the groupsTimepoint: during 14 days period after initiating oral care.

Countries

India

Contacts

Public ContactSangam Yadav

Sanjay Gandhi Postgraduate Institute of Medical Sciences

dr.sangamsgpgi@gmail.com8527698954

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026