Neurological Diseases, Heart or Respiratory Failure,NCT00771784
Effects of Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy
An observational study of Neurological Diseases, Heart or Respiratory Failure, and Sepsis, Trauma., run by University of Padova at 1 site in Italy.
Trial summary
The length of tracheal intubation may affect the subsequent ventilation with a laryngeal mask during percutaneous tracheostomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurological Diseases, Heart or Respiratory Failure,, Sepsis, Trauma.
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2008to Jul 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients.
Who may be able to join
- age 18-80 years
- mechanical ventilation
- need of percutaneous tracheostomy
Who cannot join
- previous pathologies of upper airways or of oesophagus
- risk of bleeding
- need of FiO2 >70% and/or of PEEP >10 cm H2O
- difficult insertion of laryngeal mask
- impossibility of endoscopic visualization of the laryngeal structures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Short- and of Long-term Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy.
The length of tracheal intubation may affect the subsequent ventilation with a laryngeal mask during percutaneous tracheostomy.
Read the detailed description
Percutaneous tracheostomy is routinely performed while patients are being ventilated with a laryngeal mask. The efficacy of ventilation during tracheostomy may be affected by length of previous endotracheal intubation.
This is an observational and monocentric study aimed to evaluate the impact of length of endotracheal intubation on efficacy of lung ventilation with a laryngeal mask. Two groups of patients who have to undergo elective percutaneous tracheostomy after either a short or long endotracheal intubation will be enrolled.
Data on the correlational effects of the endotracheal tube on the integrity of laryngeal structures and on ventilation will be collected.
Statistical analyses will use standard tests to compare the two groups of patients.
- Keywords
- Endotracheal intubation, tracheostomy, laryngeal mask
- Medical subject headings
- Respiratory Insufficiency, Sepsis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Short term endotracheal intubation. | |
| 2 | Long term endotracheal intubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory parameters during percutaneous tracheostomy
Measured: Thirty minutes.
Secondary outcomes (1)
Scoring of laryngeal lesions, blood gas exchange, morbidity, mortality.
Measured: Thirty minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological Diseases, Heart or Respiratory Failure,Studies 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Investigators
- Carlo Ori, Professor, Study chair, Department of Pharmacology and Anesthesiology, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771784
- Sponsor's protocol ID
- 68144
- Status last verified
- Aug 2012
- First submitted
- 10 Oct 2008
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short- and of Long-term Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy.
- ClinicalTrials.gov ID
- NCT00771784
- Acronym / sponsor ID
- 68144
- Keywords
- Endotracheal intubation, tracheostomy, laryngeal mask
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 13 Oct 2008 (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 length of tracheal intubation may affect the subsequent ventilation with a laryngeal mask during percutaneous tracheostomy.
Detailed description
Percutaneous tracheostomy is routinely performed while patients are being ventilated with a laryngeal mask. The efficacy of ventilation during tracheostomy may be affected by length of previous endotracheal intubation.
This is an observational and monocentric study aimed to evaluate the impact of length of endotracheal intubation on efficacy of lung ventilation with a laryngeal mask. Two groups of patients who have to undergo elective percutaneous tracheostomy after either a short or long endotracheal intubation will be enrolled.
Data on the correlational effects of the endotracheal tube on the integrity of laryngeal structures and on ventilation will be collected.
Statistical analyses will use standard tests to compare the two groups of patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Short term endotracheal intubation. |
| 2 | – | –Long term endotracheal intubation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients.
Key inclusion criteria (3 listed)
- age 18-80 years
- mechanical ventilation
- need of percutaneous tracheostomy
Key exclusion criteria (5 listed)
- previous pathologies of upper airways or of oesophagus
- risk of bleeding
- need of FiO2 >70% and/or of PEEP >10 cm H2O
- difficult insertion of laryngeal mask
- impossibility of endoscopic visualization of the laryngeal structures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventilatory parameters during percutaneous tracheostomy
Time frame: Thirty minutes.
1 secondary outcome
Scoring of laryngeal lesions, blood gas exchange, morbidity, mortality.
Time frame: Thirty minutes.
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 22 Aug 2012.
- Link of the Anesthesia and Critical Care SectionLink provided by the sponsor.
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.
Carlo Ori, Professor study chair
Department of Pharmacology and Anesthesiology, University of Padova
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 Neurological Diseases, Heart or Respiratory Failure, and Sepsis, Trauma., run by University of Padova 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 3 inclusion and 5 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 22 Aug 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.
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?
Ventilatory parameters during percutaneous tracheostomy (time frame: Thirty minutes.). 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 22 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.