Endotracheal Suctioning: open or closed?

ISRCTN ISRCTN75875670
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 of protocol

Not provided at time of registration

Contact information

Dr I P Jongerden
Scientific

P.O. Box 85500
Utrecht
3508 GA
Netherlands

+ 31 (0)30 250 3304
i.p.jongerden@umcutrecht.nl

Study information

Study designRandomised, controlled, crossover multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titlePrevention of cross-transmission of antibiotic-resistant pathogens by using closed instead of open endotracheal suction systems in mechanically ventilated intensive care patients
Study acronymES-trial
Study objectivesCross-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).
Health condition(s) or problem(s) studiedMechanical ventilation, complications
InterventionEndotracheal suctioning as indicated, according to a protocol, with either CSS or OSS.
Intervention typeOther
Primary outcome measureOccurrence 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 measures1. 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 date01/12/2006
Completion date01/03/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants500
Key inclusion criteriaAll adult ICU patients receiving mechanical vetilators (MV) will be included and, during six months, be subjected to the same endotracheal suctioning (ES)-procedure.
Key exclusion criteriaNo 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.
Date of first enrolment01/12/2006
Date of final enrolment01/03/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor information

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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article meta-analysis results 01/01/2007 Yes No
Results article results 01/12/2012 Yes No
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