Comparative Study of The Effect of Botanical Extract Mouthwashes of Tea Tree Oil/Aloe vera and Chlorhexidine on Prevention of Ventilator-Associated Pneumonia in Admitted Patients in Intensive Care Unites

Not Applicable

Recruiting

• Conditions: Ventilator-Associated Pneumonia.; Ventilator associated pneumonia; J95.851

• Registration Number: IRCT20210104049936N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

To have oral endotracheal tube
Age between 16 to 65
Being at least 72 hours ventilated
Absence of pulmonary infection based on the modified pulmonary infection clinical score (score less than 5 at the time of study entry)
Absence of history of allergy to herbal compounds of tea tree oil or aloe vera (based on the history obtained from the legal guardian or the patient's companion)
Absence of specific oral lesions or infections
Absence of sepsis, pulmonary thromboembolism, absence of history and signs of aspiration, absence of orthodontics, atelectasis, inflammatory gastrointestinal or bile ducts diseases and severe liver diseases according to the diagnosis of a specialist doctor (based on physical examination and history obtained from the legal guardian or with the patient).

Exclusion Criteria

Traumatization during intubation
Transferring patient from the ICU (for any reason) or death before completing the study
Patient extubation for any reason
Withdrawal or unwillingness of the legal guardian of the patient to continue the study
Observing side effects caused by using mouthwash such as hives, itching and skin rashes
Sudden changes in the patient's clinical condition or breathing pattern
The presence of defects in the patient's immune system

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventilator-Associated Pneumonia. Timepoint: Assessing the presence or absence of ventilator-associated pneumonia upon entering the study (before the start of the intervention), day 3 (to diagnose early ventilator-associated pneumonia) and day 7 (to diagnose late ventilator-associated pneumonia) after the intervention. Method of measurement: The diagnosis of ventilator-associated pneumonia in this research will be done using the Modified Clinical Pulmonary Infection Score (MCPIS). This tool includes five laboratory and a score of 0-2 is considered for each criterion and the maximum score is 10. If the sum of scores is equal to or more than 6, pneumonia is diagnosed.