Mechanical VentilationNCT00432718
Saline Instillation Before Tracheal Suctioning and the Incidence of Ventilator Associated Pneumonia
A study testing Saline Instillation before Tracheal Suctioning in people with Mechanical Ventilation and Critically Ill Patients, run by Hospital do Cancer, Sao Paulo at 1 site in Brazil.
Trial summary
Compare the incidence of ventilator associated pneumonia with or without tracheal isotonic saline instillation before tracheal suctioning Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Critically Ill Patients
- What is being tested?
- Saline Instillation before Tracheal Suctioning
- Type of treatment
- Surgery or procedure
- How many people
- 260 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2001to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients foreseen to receive mechanical ventilation for more than 72 hours
Who cannot join
- Previous mechanical ventilation in the last month
- Mechanical ventilation for more than 6 hours before arrival at ICU,
- Contraindication to bronchoscopy and
- Be expected to die or undergo withdrawal treatment within 48 hours-
Trial locations and contacts
1 site in 1 country.
About this study
Compare the incidence of ventilator associated pneumonia with or without tracheal isotonic saline instillation before tracheal suctioning
- Conditions
- Mechanical Ventilation, Critically Ill Patients
- Being tested
- Saline Instillation before Tracheal Suctioning
- Keywords
- Pneumonia, Ventilator Associated Pneumonia, Prevention
- Medical subject headings
- Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Instillation before Tracheal SuctioningProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of ventilator associated pneumonia
Secondary outcomes (2)
atelectasis
tube occlusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 260 participants
Sponsor and investigators
- Lead sponsor
- Hospital do Cancer, Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Pedro Caruso, MD, Principal investigator, Intensive Care Unit - Hospital do Câncer and University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432718
- Sponsor's protocol ID
- 342/01
- Status last verified
- Feb 2007
- First submitted
- 7 Feb 2007
- Last updated
- 8 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline Instillation Before Tracheal Suctioning and the Incidence of Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT00432718
- Acronym / sponsor ID
- 342/01
- Conditions
- Mechanical Ventilation, Critically Ill Patients
- Keywords
- Pneumonia, Ventilator Associated Pneumonia, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants
- Lead sponsor
- Hospital do Cancer, Sao PauloUniversity, hospital or other
- Study start
- Aug 2001
- First posted
- 8 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the incidence of ventilator associated pneumonia with or without tracheal isotonic saline instillation before tracheal suctioning
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients foreseen to receive mechanical ventilation for more than 72 hours
Key exclusion criteria (4 listed)
- Previous mechanical ventilation in the last month
- Mechanical ventilation for more than 6 hours before arrival at ICU,
- Contraindication to bronchoscopy and
- Be expected to die or undergo withdrawal treatment within 48 hours-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline Instillation before Tracheal Suctioning | Procedure or surgery | – |
Primary outcome
incidence of ventilator associated pneumonia
2 secondary outcomes
atelectasis
tube occlusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Caruso, MD principal investigator
Intensive Care Unit - Hospital do Câncer and University of Sao Paulo Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Instillation before Tracheal Suctioning in people with Mechanical Ventilation and Critically Ill Patients, run by Hospital do Cancer, Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of ventilator associated pneumonia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2007.