Oral Care as a Preventive Measure of VAP; Miswak Versus Chlorhexidine and Toothbrush.
Primary Purpose
Ventilator Associated Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral care in mechanically ventilated patients
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring VAP, Oral care, Chlorhexidine, Miswak (Sewak)
Eligibility Criteria
Inclusion Criteria:
- Mechanically ventilated
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Miswak (Sewak)
Chlorhexidine/ toothbrush
Arm Description
Miswak (sewak) oral care applied 4 hourly for oral care in mechanically ventilated patients.
Chlorhexidine 0.12 % plus toothbrushing oral care applied 4 hourly for oral care in mechanically ventilated patients.
Outcomes
Primary Outcome Measures
Dental plaque score - oropharyngeal colonization
Secondary Outcome Measures
ventilator associated pneumonia
Mortality
duration of mechanical ventilation and ICU stay
Full Information
NCT ID
NCT02288390
First Posted
October 31, 2014
Last Updated
November 10, 2014
Sponsor
University of Alexandria
1. Study Identification
Unique Protocol Identification Number
NCT02288390
Brief Title
Oral Care as a Preventive Measure of VAP; Miswak Versus Chlorhexidine and Toothbrush.
Official Title
Oral Care as a Preventive Measure of VAP; Miswak Versus Chlorhexidine and Toothbrush, a Prospective, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dental plaque score calculation and swabs of Oropharynx and teeth were collected on admission. For group I, Miswak stick was used 4 hourly for oral care. For group II, 0.12% Chlorhexidine/ toothbrush were used 4 hourly
Detailed Description
The selected patients were randomized into 2 groups by the conventional method of randomization. For each patient the following parameters were collected: patient data; age, gender; history of smoking; chronic health problems; history of drugs as steroids, chemotherapy, current antimicrobial therapy; and the primary cause of hospital and ICU admission and mechanical ventilation.
Clinical examination included assessment of disease severity on admission by Acute Physiology and Chronic Health Evaluation (APACHE II) scoring system, oral and dental examination, and dental plaque score calculation. Oropharyngeal and dental swabs were collected on admission.
The preventative VAP bundle was applied to all patients in both groups. For group I, Miswak was used for oral care, patient's teeth were brushed every 4 hours using a Miswak stick after scraping of half an inch bark from the stick end then Miswak tip was washed and compressed to make it brush like. Both buccal and lingual surfaces of teeth were brushed using mechanical method for plaque removal (in direction away from gingival margin,). The patient's tongue was brushed when possible and lip moisturizer was applied as needed. The brush like end of sewak stick was cut and replaced daily.
For group II, the patient's teeth were brushed every 4 hours using a soft toothbrush with 0.12% Chlorhexidine solution. Both buccal and lingual surfaces of teeth were brushed using mechanical method for plaque removal (in direction away from gingival margin,). The patient's tongue was brushed when possible and lip moisturizer was applied as needed. The toothbrush was boiled for one minute every day.
Patients in both groups were monitored for the efficacy of oral care in term of plaque score and halitosis. Colonization of trachea, OPH, and dental plaque by potential respiratory pathogens (PRPs) as Staphylococcus aureus, Pseudomonas, Klebsiella, Proteus, Acinetobacter and E. coli species was identified by culturing of OPH swab, dental swab and endotracheal tube (ETT) aspirate on inclusion into the study and every 4 days thereafter till ICU discharge, 3 weeks of ICU stay, or death. Secondary endpoints included time to VAP and its incidence, duration of MV, ICU discharge, and mortality rate.
VAP was diagnosed when patient developed; new and/or progressive infiltrates in chest radiograph plus two or more of the following; leucocytosis ≥ 12000/mm3 or leucopenia ≤ 4000c/mm3, fever > 38oC or hypothermia < 36oC, or mucopurulent secretion as evident by gross inspection. The clinically diagnosed VAP was confirmed by quantitative endotracheal aspirate at a cut off value ≥105 colony forming unit (cfu) /ml.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
Keywords
VAP, Oral care, Chlorhexidine, Miswak (Sewak)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Miswak (Sewak)
Arm Type
Active Comparator
Arm Description
Miswak (sewak) oral care applied 4 hourly for oral care in mechanically ventilated patients.
Arm Title
Chlorhexidine/ toothbrush
Arm Type
Active Comparator
Arm Description
Chlorhexidine 0.12 % plus toothbrushing oral care applied 4 hourly for oral care in mechanically ventilated patients.
Intervention Type
Procedure
Intervention Name(s)
Oral care in mechanically ventilated patients
Intervention Description
Oral care comparing Chlorhexidine and toothbrush versus Miswak ( the twig of Arak, Salvadora perscia, tree)
Primary Outcome Measure Information:
Title
Dental plaque score - oropharyngeal colonization
Time Frame
21 days
Secondary Outcome Measure Information:
Title
ventilator associated pneumonia
Time Frame
21 days
Title
Mortality
Time Frame
21 days
Title
duration of mechanical ventilation and ICU stay
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mechanically ventilated
Exclusion Criteria:
None
12. IPD Sharing Statement
Learn more about this trial
Oral Care as a Preventive Measure of VAP; Miswak Versus Chlorhexidine and Toothbrush.
We'll reach out to this number within 24 hrs