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

Completed

• Conditions: Ventilator Associated Pneumonia Prevention; Mechanical Ventilation; Critical Care; Toothbrushing; Oral Care

• Registration Number: NCT02400294
• Lead Sponsor: University Hospital, Clermont-Ferrand

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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2030

Inclusion Criteria

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

Exclusion Criteria

• Edentulous patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nosocomial ventilator associated pneumonia	at Day-28	Presence 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 Outcome Measures

Name	Time	Method
Hospital mortality	at Day-90
ICU length of stay	at Day-90
ICU mortality	at Day-90
Tracheobronchitis	at Day-28	Association 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.
Antibiotic free days	at Day-90

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France