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

NCT02400294 | Completed

• 1 other identifier: CHU-0227
• Study Type: observational
• Target: 2,030
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Tracheobronchitis

  at Day-28

• ICU length of stay

  at Day-90

• ICU mortality

  at Day-90

• Hospital mortality

  at Day-90

• Antibiotic free days

  at Day-90

Interventions

Toothbrushing OTHER

Toothbrushing associated with standard oral care in mechanically ventilated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

mechanically ventilated patients

You may qualify if:

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

You may not qualify if:

• Edentulous patients

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• Ory J, Mourgues C, Raybaud E, Chabanne R, Jourdy JC, Belard F, Guerin R, Cosserant B, Faure JS, Calvet L, Pereira B, Guelon D, Traore O, Gerbaud L. Cost assessment of a new oral care program in the intensive care unit to prevent ventilator-associated pneumonia. Clin Oral Investig. 2018 Jun;22(5):1945-1951. doi: 10.1007/s00784-017-2289-6. Epub 2017 Nov 30.

  PMID: 29189950 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Officials

• Russel CHABANNE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 27, 2015
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 3, 2016

Record last verified: 2016-05

Locations

FR (1)