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OpenTrials
Completed

NCT Number: NCT02400294

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

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

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Key information

Conditions

Critical Care Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Mechanical Ventilation Oral Care Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Toothbrushing Ventilator Associated Pneumonia Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Edentulous patients

Treatment and study plan

Toothbrushing

Other

Toothbrushing associated with standard oral care in mechanically ventilated patients

Primary outcomes

  1. Nosocomial ventilator associated pneumonia

    Time frame: 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 outcomes

  1. Tracheobronchitis

    Time frame: 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.

  2. ICU length of stay

    Time frame: at Day-90

  3. ICU mortality

    Time frame: at Day-90

  4. Hospital mortality

    Time frame: at Day-90

  5. Antibiotic free days

    Time frame: at Day-90

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2015
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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