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

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400294
• Other study ID #: CHU-0227
• Status: Completed
• Phase: N/A
• First received: March 16, 2015
• Last updated: May 2, 2016
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: May 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2030
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients

• Intubated mechanically ventilated ICU patient

• Platelets count >50G/L

Exclusion Criteria:

• Edentulous patients

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Mechanical Ventilation
• Oral Care
• Pneumonia
• Pneumonia, Ventilator-Associated
• Toothbrushing
• Ventilator Associated Pneumonia Prevention

Intervention

Other:
• Toothbrushing
Toothbrushing associated with standard oral care in mechanically ventilated patients

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nosocomial ventilator associated pneumonia	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).	at Day-28	No
Secondary	Tracheobronchitis	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.	at Day-28	No
Secondary	ICU length of stay		at Day-90	No
Secondary	ICU mortality		at Day-90	No
Secondary	Hospital mortality		at Day-90	No
Secondary	Antibiotic free days		at Day-90	No