Acute Respiratory FailureNCT01792258
Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit
An observational study of Acute Respiratory Failure and Neurological Disease, run by University of Genova at 1 site in Italy.
Trial summary
Tracheostomy is worldwide performed in Intensive Care Unit (ICU). According to the current literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper airway obstruction. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Acute Respiratory Failure, Neurological Disease, Heart Failure
- What is being tested?
- Percutaneous tracheostomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2012to Jan 2017
- Phase
- Observational
- 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 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Criticall ill patients requiring percutaneous tracheostomy in intensive care unit
Who may be able to join
- age >18
- indication for tracheostomy
Who cannot join
- infectious disease of neck
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Genoa
Genoa, Italy, 16132
Paolo Pelosi, professor, +39 010 555 3136, ppelosi@hotmail.com
Paolo Pelosi, professor
About this study
Official title: Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit
Tracheostomy is worldwide performed in Intensive Care Unit (ICU). According to the current literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper airway obstruction. Many studies have focused on the comparison between different PDT techniques and complication. The aim of our study is to evaluate the procedural features, complications, ICU mortality, quality of life, post-discharge mortality of patients undergoing different PDT techniques performed in ICU.
- Being tested
- Percutaneous tracheostomy
- Keywords
- Percutaneous tracheostomy, Intensive Care Unit, Ineffective Airway Clearance, Weaning failure
- Medical subject headings
- Nervous System Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous tracheostomyProcedure or surgery
Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| critical ill patients | The investigator will enroll all the critical ill patients undergoing percutaneous tracheostomy performed in ICU Receives: Procedure: Percutaneous tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of percutaneous tracheostomy
Measured: at the beginning and at the end of the procedure
Secondary outcomes (6)
Early complications
Early complications are:multiple intubation attempts (more than 1), accidental extubation, paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax
Measured: in the first 24 hours from the end of the procedure
Late complications
Late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.
Measured: from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)
Quality of life
The investigator will use the EURO-QOL
Measured: at 3, 6 and 12 months after tracheostomy
Evaluation of organ function
The investigator will perform a flexible fiberoptic laryngoscopy.
Measured: At 3, 6 , and 12 months after tracheostomy
Quality of voice
the investigator will use a KAY elemetrics analyzer.
Measured: At 3,6, 12 months after tracheostomy
Mortality
Measured: at 3, 6 and 12 months from tracheostomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionFeb 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 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
- Investigators
- Paolo Pelosi, Principal investigator, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792258
- Sponsor's protocol ID
- 53/12
- Status last verified
- Feb 2016
- First submitted
- 6 Feb 2013
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01792258
- Acronym / sponsor ID
- 53/12
- Keywords
- Percutaneous tracheostomy, Intensive Care Unit, Ineffective Airway Clearance, Weaning failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 15 Feb 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 performed in Intensive Care Unit (ICU). According to the current literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper airway obstruction. Many studies have focused on the comparison between different PDT techniques and complication. The aim of our study is to evaluate the procedural features, complications, ICU mortality, quality of life, post-discharge mortality of patients undergoing different PDT techniques performed in ICU.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critical ill patients | – | Procedure: Percutaneous tracheostomyThe investigator will enroll all the critical ill patients undergoing percutaneous tracheostomy performed in ICU |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Criticall ill patients requiring percutaneous tracheostomy in intensive care unit
Key inclusion criteria (2 listed)
- age >18
- indication for tracheostomy
Key exclusion criteria (1 listed)
- infectious disease of neck
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 |
|---|---|---|
| Percutaneous tracheostomyPercutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice. | Procedure or surgery | critical ill patients |
Primary outcome
Safety of percutaneous tracheostomy
Time frame: at the beginning and at the end of the procedure
6 secondary outcomes
Early complications
Time frame: in the first 24 hours from the end of the procedure
Late complications
Time frame: from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)
Quality of life
Time frame: at 3, 6 and 12 months after tracheostomy
Evaluation of organ function
Time frame: At 3, 6 , and 12 months after tracheostomy
Quality of voice
Time frame: At 3,6, 12 months after tracheostomy
Mortality
Time frame: at 3, 6 and 12 months from tracheostomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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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 principal investigator
Universita degli Studi di Genova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Neurological Disease, run by University of Genova 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 1 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 3 Feb 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Pelosi, professor (+39 010 5553136, ppelosi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of percutaneous tracheostomy (time frame: at the beginning and at the end of the procedure). 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 3 Feb 2016.