search
Back to results

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
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring VAP, Oral care, Chlorhexidine, Miswak (Sewak)

Eligibility Criteria

2 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 31, 2014
    Last Updated
    November 10, 2014
    Sponsor
    University of Alexandria
    search

    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