Endotracheal Suctioning: open or closed?
| ISRCTN | ISRCTN75875670 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75875670 |
| Protocol serial number | NTR770 |
| Sponsor | University Medical Center Utrecht (UMCU) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- 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
Scientific
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | + 31 (0)30 250 3304 |
|---|---|
| i.p.jongerden@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, crossover multicentre trial |
| Secondary study design | Randomised controlled trial |
| 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 objectives | 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). |
| Health condition(s) or problem(s) studied | Mechanical ventilation, complications |
| Intervention | Endotracheal suctioning as indicated, according to a protocol, with either CSS or OSS. |
| Intervention type | Other |
| Primary outcome measure(s) |
Occurrence of cross-transmission (primary endpoint), defined as acquired colonisation with a genetically identical pathogen with an epidemiological linkage to a potential source patient. |
| Key secondary outcome measure(s) |
1. Length of stay in ICU |
| Completion date | 01/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 500 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 01/03/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P.O. Box 85500
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
