Condition category
Infections and Infestations
Date applied
02/05/2006
Date assigned
09/06/2006
Last edited
04/08/2006
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 Leonardo Lorente

ORCID ID

Contact details

Intensive Care Unit
Hospital Universitario de Canarias
Ofra s/n
La Laguna
38320
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Patients mechanically ventilated for more than 5 days may develop lower ventilator-associated pneumonia with a heated humidifier than with a heat and moisture exchanger.

Ethics approval

Ethics Committee of the University Hospital of the Canaries on 05/02/2004

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Pneumonia

Intervention

Humidification with a heated humidifier or a heat and moisture exchanger

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Heated humidifier decreases ventilator-associated pneumonia incidence

Secondary outcome measures

Heated humidifier decreases secondary endogenous ventilator-associated pneumonia

Overall trial start date

01/01/2005

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients expected to require mechanical ventilation for more than 5 days

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Age <18 years
2. Human immunodeficiency virus (HIV)
3. Blood leukocytes counts <1000 cells per mm^3
4. Solid or hematological tumour
5. Immunosuppressive therapy

Recruitment start date

01/01/2005

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Spain

Trial participating centre

Intensive Care Unit
La Laguna
38320
Spain

Sponsor information

Organisation

University Hospital of the Canaries (Hospital Universitario de Canarias) (Spain)

Sponsor details

Ofra s/n
La Laguna
38320
Spain

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Hospital of the Canarias

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16884530

Publication citations

  1. Lorente L, Lecuona M, Jiménez A, Mora ML, Sierra A, Ventilator-associated pneumonia using a heated humidifier or a heat and moisture exchanger: a randomized controlled trial [ISRCTN88724583]., Crit Care, 2006, 10, 4, R116, doi: 10.1186/cc5009.

Additional files

Editorial Notes