Respiratory FailureNCT01899352
Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units.
A study testing Tracheostomy in people with Respiratory Failure and Neurological Disease, run by University of Genova at 11 sites in Italy.
Trial summary
Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess the mortality, quality of life, laryngeal function, procedures, early and late complications of tracheostomy performed for critically ill patients admitted in intensive care units. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Failure, Neurological Disease, Heart Failure
- What is being tested?
- Tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 11 sitesItaly
- Study dates
- Jan 2014to Jan 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- indications for tracheostomy
Who cannot join
- Infection/inflammation of neck tissue
- Previous neck surgery causing abnormal anatomy of the site
- Recent surgery of cervical spine
Trial locations and contacts
11 sites in 1 country.
Paolo Pelosi, MD contact
Maria Vargas contact
11 sites in 1 country
Italy11 sites
Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care
Assisi, Italy
Giulio Frova, giulio.frova@alice.it
Giulio Frova
Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care
Assisi, Italy
Policlinico Vittoio Emanuele
Catania, Italy
Massimiliano Sorbello, maxsorbello@gmail.com
Massi,iliano Sorbello
Policlinico SS Annunziata
Chieti, Italy
Flavia Petrini, flavia.petrini@unich.it
Flavia Petrini
Intensive care unit - San Martino-IST
Genoa, Italy, 16132
Paolo Pelosi, MD, ppelosi@hotmail.com
Maria Vargas, MD, vargas.maria82@gmail.com
IRCCS Azienda Ospedaliera San Martino IST
Genoa, Italy, 16132
Centro Cardiologico Monzino
Milan, Italy
Guido Merli, guidomerli@gmail.com
Guido Merli
University of Naples "Federico II"
Naples, Italy, 80100
Maria Vargas, MD, vargas.maria82@gmail.com
Maria Vargas, MD
Ospedale Morgagni-Pierantoni
Rimini, Italy
Ruggero Corso, rmcorso@gmail.com
Ruggero Corso
Università Cattolica del Sacro Cuore
Rome, Italy
Massimo Antonelli, m.antonelli@rmunicatt.it
Massimo Antonelli
Università di Torino
Turin, Italy
Marco V Ranieri, marco.ranieri@unito.it
Pierpaolo Terragni
About this study
Official title: Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units - a Prospective Study by Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI)
Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess the mortality, quality of life, laryngeal function, procedures, early and late complications of tracheostomy performed for critically ill patients admitted in intensive care units.
- Being tested
- Tracheostomy
- Medical subject headings
- Respiratory Insufficiency, Nervous System Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TracheostomyProcedure or surgery
Percutaneous and surgical tracheostomies will be performed with the procedure currently available in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Tracheostomy | Other | The investigators will enroll all the critical ill patients undergoing tracheostomy performed in intensive care units Receives: Procedure: Tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at ICU discharge
Measured: within 2 days after discharge
Secondary outcomes (5)
Quality of Life
Quality of life will be evaluated at 3, 6 and 12 months after the discharge from the intensive care unit.
Measured: within 2 days after discharge, at 3, 6 and 12 months after tracheostomy
Laryngeal organ function
Laryngeal organ function will be evaluated at 3, 6 and 12 months after the discharge from intensive care unit.
Measured: within 2 days after discharge, at 3, 6 and 12 months after tracheostomy
Late complications
Measured: from day 2 until the discharge
Procedural findings of percutaneous tracheostomy
Measured: at the beginning and at the end of tracheostomy procedures
Early complication
Measured: in the first 24 hours from the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
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 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Pelosi, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899352
- Sponsor's protocol ID
- PCF-TracheoTrial
- Status last verified
- Jul 2013
- First submitted
- 2 Jul 2013
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vargas M, Battaglini D, Antonelli M, Corso R, Frova G, Merli G, Petrini F, Ranieri MV, Sorbello M, Di Giacinto I, Terragni P, Brunetti I, Servillo G, Pelosi P. Follow-up short and long-term mortalities of tracheostomized critically ill patients in an Italian multi-center observational study. Sci Rep. 2024 Jan 28;14(1):2319. doi: 10.1038/s41598-024-52785-y.
PubMed 38281994
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units - a Prospective Study by Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI)
- ClinicalTrials.gov ID
- NCT01899352
- Acronym / sponsor ID
- PCF-TracheoTrial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 15 Jul 2013 (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.
Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess the mortality, quality of life, laryngeal function, procedures, early and late complications of tracheostomy performed for critically ill patients admitted in intensive care units.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracheostomy | Other | Procedure: TracheostomyThe investigators will enroll all the critical ill patients undergoing tracheostomy performed in intensive care units |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- indications for tracheostomy
Key exclusion criteria (3 listed)
- Infection/inflammation of neck tissue
- Previous neck surgery causing abnormal anatomy of the site
- Recent surgery of cervical spine
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 |
|---|---|---|
| TracheostomyPercutaneous and surgical tracheostomies will be performed with the procedure currently available in clinical practice. | Procedure or surgery | Tracheostomy |
Primary outcome
Mortality at ICU discharge
Time frame: within 2 days after discharge
5 secondary outcomes
Quality of Life
Time frame: within 2 days after discharge, at 3, 6 and 12 months after tracheostomy
Laryngeal organ function
Time frame: within 2 days after discharge, at 3, 6 and 12 months after tracheostomy
Late complications
Time frame: from day 2 until the discharge
Procedural findings of percutaneous tracheostomy
Time frame: at the beginning and at the end of tracheostomy procedures
Early complication
Time frame: in the first 24 hours from the end of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
- Derived from this study: PubMed 38281994Vargas M, Battaglini D, Antonelli M, Corso R, Frova G, Merli G, Petrini F, Ranieri MV, Sorbello M, Di Giacinto I, Terragni P, Brunetti I, Servillo G, Pelosi P. Follow-up short and long-term mortalities of tracheostomized critically ill patients in an Italian multi-center observational study. Sci Rep. 2024 Jan 28;14(1):2319. doi: 10.1038/s41598-024-52785-y.
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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.
Paolo Pelosi, MD contact
Maria Vargas contact
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheostomy in people with Respiratory Failure and Neurological Disease, run by University of Genova at 11 sites 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 3 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: status not confirmed, as of the sponsor's last update on 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Pelosi, MD (ppelosi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at ICU discharge (time frame: within 2 days after discharge). 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 NCT01899352, 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 15 Jul 2013.