Condition category
Respiratory
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
31/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr I P Jongerden

ORCID ID

Contact details

P.O. Box 85500
Utrecht
3508 GA
Netherlands
+ 31 (0)30 250 3304
i.p.jongerden@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR770

Study information

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

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

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).

Study design

Randomised, controlled, crossover multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Mechanical ventilation, complications

Intervention

Endotracheal suctioning as indicated, according to a protocol, with either CSS or OSS.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/12/2006

Overall trial end date

01/03/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

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

Trial participating centre

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

Department of Intensive Care
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 meta-analysis results in http://www.ncbi.nlm.nih.gov/pubmed/17133187
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22520496

Publication citations

  1. Results

    Jongerden IP, Kesecioglu J, Speelberg B, Buiting AG, Leverstein-van Hall MA, Bonten MJ, Changes in heart rate, mean arterial pressure, and oxygen saturation after open and closed endotracheal suctioning: a prospective observational study., J Crit Care, 2012, 27, 6, 647-654, doi: 10.1016/j.jcrc.2012.02.016.

  2. Jongerden IP, Rovers MM, Grypdonck MH, Bonten MJ, Open and closed endotracheal suction systems in mechanically ventilated intensive care patients: a meta-analysis., Crit. Care Med., 2007, 35, 1, 260-270, doi: 10.1097/01.CCM.0000251126.45980.E8.

Additional files

Editorial Notes