Respiratory FailureVICTORNCT02223988
Occurrence of Ventilator Associated Pneumonia in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage
A study testing subglottic secretion removal in people with Respiratory Failure, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks of morbidity and mortality for patients who require mechanical ventilation. VAP is associated with the contamination and colonization of bacteria in the lower airway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- subglottic secretion removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2014to Jul 2016
- 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
- Patients on mechanical ventilation for respiratory failure for at least 72 hours.
- A score of 35 to 65 on the Simplified Acute Physiology Score II (SAPS II).
- Does not have a pulmonary infection estimated by a Clinical Pulmonary Infection Score (CPIS).
- Age >= 18 years.
- have no exclusion criteria
Who cannot join
- A history of esophageal, tracheal or pulmonary cancer or an existing malignancy within the trachea at the tracheostomy site.
- Previous surgery at the tracheostomy site (e.g. thyroidectomy).
- Bleeding diathesis (e.g. due to anticoagulation therapy).
- Emergency surgical airway management.
- Morbid obesity and/or neck edema (skin to trachea distance may render tracheostomy tube too short).
- Pre-existing infection at the tracheostomy site.
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- Uncertainty in identifying the anatomical landmarks.
- Patients with a do not resuscitate order.
- Immunosuppressed and/or immunodepressed patients (Immunodepression being defined by the following conditions: 1-Leukocytes < 1000/µl, 2-Neutrophils < 500/µl. 3-AIDS Long-term steroid treatment (daily dose > 0.5 mg/kg) for more than 30 days)
- Patients already enrolled in other trials
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Turin - Department of Anesthesia and Intensive Care Medicine
Turin, 10126
About this study
Official title: Occurrence of Ventilator Associated Pneumonia (VAP) in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage: a Prospective Observational Study.
Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks of morbidity and mortality for patients who require mechanical ventilation.
VAP is associated with the contamination and colonization of bacteria in the lower airway. These bacteria may be present in the lower airway by the aspiration of oropharyngeal secretions. Therefore limiting the amount of secretions that pass the glottis and enter the airway is paramount.
Read more
Patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to manage breathing. These tubes may have a distal cuff which sits within the trachea. When the cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube thereby limiting the amount of secretions entering the lower airway. These secretions may leak around the cuff and cause tracheobronchial colonization. It has been shown that removal of secretions that pool above the cuff via dorsal lumen suction leads to a decreased incidence of VAP.
The purpose of this study is to measure the effect of suction above the cuff tracheostomy tubes related to VAP incidence
- Conditions
- Respiratory Failure
- Being tested
- subglottic secretion removal
- Keywords
- Patients, mechanical, ventilation, tracheostomy
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subglottic secretion removalProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| subglottic secretion drainage | Experimental | Not described Receives: Procedure: subglottic secretion removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of VAP
Measured: at 28 days
Secondary outcomes (4)
Mortality rate
Mortality at 28-day (all-cause mortality) starting from enrollment (at tracheostomy time)
Measured: at 28 days
Duration of mechanical ventilation
Measured: 30 days
ICU length of stay
Measured: 30 days
Ventilator free days after tracheostomy
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ranieri, University of Turin, Italy
- Investigators
- Pierpaolo Terragni, MD, Principal investigator, Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223988
- Sponsor's protocol ID
- CS/202
- Acronym
- VICTOR
- Status last verified
- May 2017
- First submitted
- 21 Aug 2014
- Last updated
- 9 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occurrence of Ventilator Associated Pneumonia (VAP) in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT02223988
- Acronym / sponsor ID
- VICTOR / CS/202
- Conditions
- Respiratory Failure
- Keywords
- Patients, mechanical, ventilation, tracheostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Aug 2014 (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.
Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks of morbidity and mortality for patients who require mechanical ventilation.
VAP is associated with the contamination and colonization of bacteria in the lower airway. These bacteria may be present in the lower airway by the aspiration of oropharyngeal secretions. Therefore limiting the amount of secretions that pass the glottis and enter the airway is paramount.
Patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to manage breathing. These tubes may have a distal cuff which sits within the trachea. When the cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube thereby limiting the amount of secretions entering the lower airway. These secretions may leak around the cuff and cause tracheobronchial colonization. It has been shown that removal of secretions that pool above the cuff via dorsal lumen suction leads to a decreased incidence of VAP.
The purpose of this study is to measure the effect of suction above the cuff tracheostomy tubes related to VAP incidence
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subglottic secretion drainage | Experimental | Procedure: subglottic secretion removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients on mechanical ventilation for respiratory failure for at least 72 hours.
- A score of 35 to 65 on the Simplified Acute Physiology Score II (SAPS II).
- Does not have a pulmonary infection estimated by a Clinical Pulmonary Infection Score (CPIS).
- Age >= 18 years.
- have no exclusion criteria
Key exclusion criteria (10 listed)
- A history of esophageal, tracheal or pulmonary cancer or an existing malignancy within the trachea at the tracheostomy site.
- Previous surgery at the tracheostomy site (e.g. thyroidectomy).
- Bleeding diathesis (e.g. due to anticoagulation therapy).
- Emergency surgical airway management.
- Morbid obesity and/or neck edema (skin to trachea distance may render tracheostomy tube too short).
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 |
|---|---|---|
| subglottic secretion removal | Procedure or surgery | subglottic secretion drainage |
Primary outcome
Incidence of VAP
Time frame: at 28 days
4 secondary outcomes
Mortality rate
Time frame: at 28 days
Duration of mechanical ventilation
Time frame: 30 days
ICU length of stay
Time frame: 30 days
Ventilator free days after tracheostomy
Time frame: 28 days
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 9 May 2017.
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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.
Pierpaolo Terragni, MD principal investigator
Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subglottic secretion removal in people with Respiratory Failure, run by University of Turin, Italy at 1 site in Italy.
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 5 inclusion and 10 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 9 May 2017. 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 Italy. 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 VAP (time frame: at 28 days). 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 9 May 2017.