Respiratory InsufficiencyPhase 3NCT00262431
Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)
A Phase 3 study testing Tracheostomy on day 3-5 in early group and 10-12 in late group in people with Respiratory Insufficiency, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Tracheostomy on day 3-5 in early group and 10-12 in late group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2004to Oct 2008
- Phase
- Phase 3
- 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
- Oro/nasotracheal intubation for less than three days
- Simplified Acute Physiology Score (SAPS II) between 35 and 65 upon admission to Intensive Care Unit (ICU)
Who cannot join
- Oro/nasotracheal intubation > three days
- Age < 18 years
- Previous otolaryngologic or maxillofacial procedures
- Brain injury patients with intracranial pressure > 20 mmHg without pharmacological treatment (or intracranial pressure > 15 mmHg under specific pharmacological treatment) and with cerebral perfusion pressure < 60 mmHg
- Pregnancy
- Ventilator associated pneumonia, hospital acquired pneumonia, community acquired pneumonia diagnosis before randomization
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- Infection in the tracheostomic area
- Acute worsening of chronic obstructive pulmonary disease (COPD)
- Pre-existing malignancies in the tracheostomic area
- Immunosuppressed and/or immunodepressed patients:
- leukocytes < 1000/microliters
- neutrophils < 500/microliters
- 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
The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.
Read the detailed description
Tracheostomy is an essential and irreplaceable procedure for critically ill patients requiring mechanical ventilatory support and adequate airway control. The therapeutical choice of performing a tracheostomy is supported by a number of clinical benefits, such as less use of drugs for sedation, fewer days of mechanical ventilation and hence shorter Intensive Care Unit (ICU) length of stay, as well as better resource rationalization. Actually there is no agreement on the best timing for tracheostomy. The aim of this study is to verify if an early tracheostomy (one to three days after intubation) increases ventilator associated pneumonia-free days. Secondary endpoints are: increase of ventilator free-days and mortality reduction.
- Conditions
- Respiratory Insufficiency
- Being tested
- Tracheostomy on day 3-5 in early group and 10-12 in late group
- Keywords
- Tracheostomy, Tracheostomy timing, Ventilator associated pneumonia, Mechanical ventilation
- Medical subject headings
- Respiratory Insufficiency, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheostomy on day 3-5 in early group and 10-12 in late groupProcedure or surgery
Upon admission to ICU, acute respiratory failure patients requiring at least 3 days of mechanical ventilation and defined by a SAPS II score between 35 and 65, will be randomly assigned to either arm A or B of the study.
| Study group | Role | What they receive |
|---|---|---|
| Early (A) | Active comparator | Patients of the EARLY group (A) will be submitted to tracheostomy on day 3-5 from oro/nasotracheal intubation. Receives: Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group |
| Late (B) | Active comparator | Patients of the LATE group (B) will undergo tracheostomy on day 10-12 from oro/nasotracheal intubation. Receives: Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of "ventilator associated pneumonia-free days"
Measured: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation.
Secondary outcomes (2)
Increase of "ventilator-free days"
Measured: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation
Reduction of mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Piemonte
- Responsible party
- Principal investigator, Marco Ranieri, University of Turin, Italy
- Investigators
- V. M. Ranieri, MD, Principal investigator, University of Turin, ItalyV. M. Ranieri, MD, Study director, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262431
- Sponsor's protocol ID
- 1431/28.3
- Status last verified
- Jun 2012
- First submitted
- 5 Dec 2005
- Last updated
- 8 Jun 2012
- Results posted
- No
Publications
Terragni PP, Antonelli M, Fumagalli R, Faggiano C, Berardino M, Pallavicini FB, Miletto A, Mangione S, Sinardi AU, Pastorelli M, Vivaldi N, Pasetto A, Della Rocca G, Urbino R, Filippini C, Pagano E, Evangelista A, Ciccone G, Mascia L, Ranieri VM. Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial. JAMA. 2010 Apr 21;303(15):1483-9. doi: 10.1001/jama.2010.447.
PubMed 20407057
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)
- ClinicalTrials.gov ID
- NCT00262431
- Acronym / sponsor ID
- 1431/28.3
- Conditions
- Respiratory Insufficiency
- Keywords
- Tracheostomy, Tracheostomy timing, Ventilator associated pneumonia, Mechanical ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Regione Piemonte
- Study start
- Jun 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 6 Dec 2005 (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.
The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.
Detailed description
Tracheostomy is an essential and irreplaceable procedure for critically ill patients requiring mechanical ventilatory support and adequate airway control. The therapeutical choice of performing a tracheostomy is supported by a number of clinical benefits, such as less use of drugs for sedation, fewer days of mechanical ventilation and hence shorter Intensive Care Unit (ICU) length of stay, as well as better resource rationalization. Actually there is no agreement on the best timing for tracheostomy. The aim of this study is to verify if an early tracheostomy (one to three days after intubation) increases ventilator associated pneumonia-free days. Secondary endpoints are: increase of ventilator free-days and mortality reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early (A) | Active comparator | Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late groupPatients of the EARLY group (A) will be submitted to tracheostomy on day 3-5 from oro/nasotracheal intubation. |
| Late (B) | Active comparator | Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late groupPatients of the LATE group (B) will undergo tracheostomy on day 10-12 from oro/nasotracheal intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Oro/nasotracheal intubation for less than three days
- Simplified Acute Physiology Score (SAPS II) between 35 and 65 upon admission to Intensive Care Unit (ICU)
Key exclusion criteria (15 listed)
- Oro/nasotracheal intubation > three days
- Age < 18 years
- Previous otolaryngologic or maxillofacial procedures
- Brain injury patients with intracranial pressure > 20 mmHg without pharmacological treatment (or intracranial pressure > 15 mmHg under specific pharmacological treatment) and with cerebral perfusion pressure < 60 mmHg
- Pregnancy
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 |
|---|---|---|
| Tracheostomy on day 3-5 in early group and 10-12 in late groupUpon admission to ICU, acute respiratory failure patients requiring at least 3 days of mechanical ventilation and defined by a SAPS II score between 35 and 65, will be randomly assigned to either arm A or B of the study. | Procedure or surgery | Early (A), Late (B) |
Primary outcome
Increase of "ventilator associated pneumonia-free days"
Time frame: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation.
2 secondary outcomes
Increase of "ventilator-free days"
Time frame: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation
Reduction of mortality
Time frame: one year
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 Jun 2012.
- Derived from this study: PubMed 20407057Terragni PP, Antonelli M, Fumagalli R, Faggiano C, Berardino M, Pallavicini FB, Miletto A, Mangione S, Sinardi AU, Pastorelli M, Vivaldi N, Pasetto A, Della Rocca G, Urbino R, Filippini C, Pagano E, Evangelista A, Ciccone G, Mascia L, Ranieri VM. Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial. JAMA. 2010 Apr 21;303(15):1483-9. doi: 10.1001/jama.2010.447.
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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.
V. M. Ranieri, MD principal investigator
University of Turin, Italy
V. M. Ranieri, MD study director
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 Phase 3 study testing Tracheostomy on day 3-5 in early group and 10-12 in late group in people with Respiratory Insufficiency, 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 2 inclusion and 15 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 Jun 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Increase of "ventilator associated pneumonia-free days" (time frame: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00262431, which also lists 1 linked publication.
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 Jun 2012.