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Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients

Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02400294
Enrollment
2030
Registered
2015-03-27
Start date
2014-07-31
Completion date
2015-07-31
Last updated
2016-05-03

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

Conditions

Critical Care, Mechanical Ventilation, Oral Care, Toothbrushing, Ventilator Associated Pneumonia Prevention

Keywords

Critical care, Mechanical ventilation, Ventilator associated pneumonia, Oral care

Brief summary

Effect of toothbrushing in oral care of mechanically ventilated critically ill patients on prevention of ventilator associated pneumonia

Detailed description

Prospective, before and after study in 5 Intensive Care Units (ICUs) of a university hospital. The before period (control phase, 6 months): standard oral care 3 times a day in every consecutive intubated patients in the participating ICUs The interphase period (1 month): formal training of all the nurses, physicians and residents on the use of toothbrushing during oral care The after period: (study phase, 6 months): standard oral care with tooth brushing 3 times a day in every consecutive intubated patients in the participating ICUs

Interventions

OTHERToothbrushing

Toothbrushing associated with standard oral care in mechanically ventilated patients

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients * Intubated mechanically ventilated ICU patient * Platelets count \>50G/L

Exclusion criteria

* Edentulous patients

Design outcomes

Primary

MeasureTime frameDescription
Nosocomial ventilator associated pneumoniaat Day-28Presence of at least two signs (body fever greater than 38°C; leukocytosis greater than 12000/ml or leukopenia below 4000/ml, purulent pulmonary secretions) associated with the appearance of a new infiltrate or modification of an existing infiltrate on chest-X-ray. Confirmation by a lower respiratory tract sample using a quantitative culture with a predefined positive threshold. Hospital-acquired pneumonia was defined as a pneumonia that occurs at least 48 hours after admission, which was not incubating at time of admission (Am J Respir Crit Care Med 2005; 171, 388-416).

Secondary

MeasureTime frameDescription
Tracheobronchitisat Day-28Association of at least two signs (fever above 38.0°C, Leucocytosis above 12000/ml or purulent pulmonary secretions) with isolation of bacteria in a lower respiratory tract sample without modification of chest-X-Ray.
ICU length of stayat Day-90
ICU mortalityat Day-90
Hospital mortalityat Day-90
Antibiotic free daysat Day-90

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026