Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT00842478 |
Date of registration:
|
11/02/2009 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia
RASPALL |
Scientific title:
|
Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia |
Date of first enrolment:
|
May 2005 |
Target sample size:
|
400 |
Recruitment status: |
Recruiting |
URL:
|
http://clinicaltrials.gov/show/NCT00842478 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
|
Phase:
|
Phase 2/Phase 3
|
|
Countries of recruitment
|
Spain
| | | | | | | |
Contacts
|
Name:
|
Jordi Rello, MD, PhD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Hospital Universitari Joan XXIII |
|
Name:
|
Angel Pobo, MD |
Address:
|
|
Telephone:
|
34 977 295818 |
Email:
|
angel.pobo@gmail.com |
Affiliation:
|
|
|
Name:
|
Angel Pobo, MD |
Address:
|
|
Telephone:
|
34 977295818 |
Email:
|
angel.pobo@gmail.com |
Affiliation:
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Adult intubated patients
- Without evidence of pulmonary infection (randomized within 12h of intubation if they
were expected to remain ventilated for longer than 48 hours)
Exclusion Criteria:
- Absence of dental pieces
- Current diagnosis of pneumonia or massive bronchoaspiration
- Tracheostomy (or expected within 48 hours)
- Chlorhexidine allergy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Nosocomial Pneumonia
|
Ventilator-Associated Pneumonia
|
Pneumonia
|
Intervention(s)
|
Procedure: Toothbrushing
|
Primary Outcome(s)
|
Ventilator-Associated Pneumonia (VAP)
[Time Frame: 28 days]
|
Secondary ID(s)
|
FIS 06/0060
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|