Ventilator Associated PneumoniaNCT02288390
Oral Care as a Preventive Measure of VAP; Miswak Versus Chlorhexidine and Toothbrush.
A study testing Oral care in mechanically ventilated patients in people with Ventilator Associated Pneumonia, run by University of Alexandria.
Trial 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 Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Oral care in mechanically ventilated patients
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mechanically ventilated
Who cannot join
- None
About this study
Official title: Oral Care as a Preventive Measure of VAP; Miswak Versus Chlorhexidine and Toothbrush, a Prospective, Randomized Controlled Study
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
Read the 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.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Oral care in mechanically ventilated patients
- Keywords
- VAP, Oral care, Chlorhexidine, Miswak (Sewak)
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral care in mechanically ventilated patientsProcedure or surgery
Oral care comparing Chlorhexidine and toothbrush versus Miswak ( the twig of Arak, Salvadora perscia, tree)
| Study group | Role | What they receive |
|---|---|---|
| Miswak (Sewak) | Active comparator | Miswak (sewak) oral care applied 4 hourly for oral care in mechanically ventilated patients. Receives: Procedure: Oral care in mechanically ventilated patients |
| Chlorhexidine/ toothbrush | Active comparator | Chlorhexidine 0.12 % plus toothbrushing oral care applied 4 hourly for oral care in mechanically ventilated patients. Receives: Procedure: Oral care in mechanically ventilated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental plaque score - oropharyngeal colonization
Measured: 21 days
Secondary outcomes (3)
ventilator associated pneumonia
Measured: 21 days
Mortality
Measured: 21 days
duration of mechanical ventilation and ICU stay
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M El-Mehalawy, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288390
- Sponsor's protocol ID
- Faculty of Medicine 10.07.2007
- Status last verified
- Nov 2014
- First submitted
- 31 Oct 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Care as a Preventive Measure of VAP; Miswak Versus Chlorhexidine and Toothbrush, a Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02288390
- Acronym / sponsor ID
- Faculty of Medicine 10.07.2007
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- VAP, Oral care, Chlorhexidine, Miswak (Sewak)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miswak (Sewak) | Active comparator | Procedure: Oral care in mechanically ventilated patientsMiswak (sewak) oral care applied 4 hourly for oral care in mechanically ventilated patients. |
| Chlorhexidine/ toothbrush | Active comparator | Procedure: Oral care in mechanically ventilated patientsChlorhexidine 0.12 % plus toothbrushing oral care applied 4 hourly for oral care in mechanically ventilated patients. |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mechanically ventilated
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral care in mechanically ventilated patientsOral care comparing Chlorhexidine and toothbrush versus Miswak ( the twig of Arak, Salvadora perscia, tree) | Procedure or surgery | Chlorhexidine/ toothbrush, Miswak (Sewak) |
Primary outcome
Dental plaque score - oropharyngeal colonization
Time frame: 21 days
3 secondary outcomes
ventilator associated pneumonia
Time frame: 21 days
Mortality
Time frame: 21 days
duration of mechanical ventilation and ICU stay
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oral care in mechanically ventilated patients in people with Ventilator Associated Pneumonia, run by University of Alexandria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental plaque score - oropharyngeal colonization (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014.