Endotracheal Suctioning: open or closed?
ISRCTN | ISRCTN75875670 |
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DOI | https://doi.org/10.1186/ISRCTN75875670 |
Secondary identifying numbers | NTR770 |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 31/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr I P Jongerden
Scientific
Scientific
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Phone | + 31 (0)30 250 3304 |
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i.p.jongerden@umcutrecht.nl |
Study information
Study design | Randomised, controlled, crossover multicentre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Prevention of cross-transmission of antibiotic-resistant pathogens by using closed instead of open endotracheal suction systems in mechanically ventilated intensive care patients |
Study acronym | ES-trial |
Study hypothesis | Cross-transmission of antibiotic-resistant pathogens can be prevented by using closed suction systems (CSS) instead of open suction systems (OSS) in mechanically ventilated intensive care unit (ICU) patients. |
Ethics approval(s) | Approval received from the Medical Ethical Review Committee, University Medical Center Utrecht (in Dutch: Medisch Ethische Toetsingscommissie, Universitair Medisch Centrum Utrecht) on September 28, 2006 (ref: 05/311-C). |
Condition | Mechanical ventilation, complications |
Intervention | Endotracheal suctioning as indicated, according to a protocol, with either CSS or OSS. |
Intervention type | Other |
Primary outcome measure | Occurrence of cross-transmission (primary endpoint), defined as acquired colonisation with a genetically identical pathogen with an epidemiological linkage to a potential source patient. |
Secondary outcome measures | 1. Length of stay in ICU 2. Antibiotic use 3. Cardio-respiratory adverse events (hypoxaemia, cardiac arrhythmia, damage to respiratory mucosa) 4. Mortality 5. The incidence of ventilator-associated pneumonia (VAP) and cost-efficacy |
Overall study start date | 01/12/2006 |
Overall study end date | 01/03/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 500 |
Participant inclusion criteria | All adult ICU patients receiving mechanical vetilators (MV) will be included and, during six months, be subjected to the same endotracheal suctioning (ES)-procedure. |
Participant exclusion criteria | No exclusion criteria. Preference of ES system is often based on assuptions, there is currently no scientific evidence available to prefer one system over the other. |
Recruitment start date | 01/12/2006 |
Recruitment end date | 01/03/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P.O. Box 85500
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
University Medical Center Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Intensive Care
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Website | http://www.umcutrecht.nl/zorg/ |
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https://ror.org/0575yy874 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | meta-analysis results | 01/01/2007 | Yes | No | |
Results article | results | 01/12/2012 | Yes | No |