Other Tracheostomy ComplicationNCT01722981
Percutaneous Tracheostomy - Systematic Comparison Among Three Methods: Prospective Study
A study testing Percutaneous tracheostomy in people with Other Tracheostomy Complication, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Percutaneous tracheostomy is routinely performed in most intensive care units in the world.Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Tracheostomy Complication
- What is being tested?
- Percutaneous tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jan 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
- All intubated patients with various injuries requiring percutaneous tracheostomy (in- house and out- house patients)
- Minimal age 18
Who cannot join
- No patient consent for participation.
- Anatomical problem which does not allow for percutaneous tracheostomy and requires open procedure in the operating room.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Akiva Nachshon, MD, 972-52-4266342, medethic@bgu.ac.il
Akiva Nachshon, MD
About this study
Official title: Percutaneous Tracheostomy - Systematic Comparison Among Three Methods: US-guided Tracheostomy, Bronchoscopy Guided Tracheostomy, and Direct Laryngoscopy Tracheostomy.
Percutaneous tracheostomy is routinely performed in most intensive care units in the world.Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room.
In our institution as in a number of institutions in the country, it is acceptable to perform the operation by placing the tube on a high position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by palpation of the neck.
Read more
Using technological aids, such as direct sonography and bronchoscopy in real time may significantly reduce the rate of complications as a result of performing percutaneous tracheostomy.
So far, no systematic comparison has been made among the three methods.
Read the detailed description
Percutaneous tracheostomy is routinely performed in most intensive care units in the world in a number of indications, such as: airway obstruction, need for a long respiratory support, improvement in respiratory toilet, prophylaxis before head and neck procedures and cases of severe obstructive sleep apnea.
Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room.
In many places around the world it is customary in to perform the operation under the guidance of a bronchoscope to prevent damage to adjacent structures, high or low position of the tube, and damage to the posterior wall of the trachea and to approve the final position of the tube. However, the use of a bronchoscope depends on the availability of the equipment, knowledge of the operator, temporary occlusion of the trachea and hypercarbia, increased length of the procedure, and maintenance cost (disinfection, replacement, etc.).
Ultrasound that is performed before percutaneous procedure may be useful in preventing damage to para tracheal adjacent structures, and preventing high placement of the tube. The use of duplex sonography with real-time visualization of the needle path is done routinely in procedures such as central venous catheterization, and may improve the safety and accuracy of percutaneous tracheostomy without causing airway obstruction or hypercarbia. Feasibility of the procedure has been reviewed in an article by Rajajee et al .
In our institution as in a number of institutions in the country, it is acceptable to perform the operation by placing the tube on a high position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by palpation of the neck.
So far, no systematic comparison has been made among the three methods.
- Conditions
- Other Tracheostomy Complication
- Being tested
- Percutaneous tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous tracheostomyProcedure or surgery
Three methods of percutaneous tracheostomy
| Study group | Role | What they receive |
|---|---|---|
| Direct laryngoscopy | Active comparator | Performing percutaneous tracheostomy as accepted in our institute: By placing the tube higher up near the vocal cords by direct laryngoscopy. In the second stage tracheal perforation by a needle will be carried out by palpation of the anatomical placement of the neck. Receives: Procedure: Percutaneous tracheostomy |
| Real time sonography | Active comparator | Percutaneous tracheostomy will be guided by real time sonography (with the visualization of the needle path) using acoustic shadows of the cricoid and the tracheal rings.
In both methods, in order to identify the anatomic location of the needle prick- after passing the guide wire, the front elevation will be verified by optical means, which will be drawn out immediately afterwards. Receives: Procedure: Percutaneous tracheostomy |
| Bronchoscopy | Active comparator | Percutaneous tracheostomy will be guided by bronchoscopy. Initially, the tube will be placed according to the desired height observed by the bronchoscope, phase two will be tracheal perforation by a needle under trans illumination and real-time view on the income of the needle and the passage of the guide wire. Receives: Procedure: Percutaneous tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systematic comparison
a systematic comparison among the three methods of percutaneous tracheostomy in terms of safety: minor and major periprocedural morbidity and mortality, up to 30 days.
Measured: 3 years
Secondary outcomes (1)
Minor morbidity
Minor morbidity among patients, and a comparison between the in-house patients to the rest of hospitalized patients that come to the unit for the procedure, according to the same criteria.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Tracheostomy ComplicationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Patrick Sorkine, professor, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722981
- Sponsor's protocol ID
- TASMC-12-PS-0408-12-CTIL
- Status last verified
- Nov 2012
- First submitted
- 4 Nov 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tracheostomy - Systematic Comparison Among Three Methods: US-guided Tracheostomy, Bronchoscopy Guided Tracheostomy, and Direct Laryngoscopy Tracheostomy.
- ClinicalTrials.gov ID
- NCT01722981
- Acronym / sponsor ID
- TASMC-12-PS-0408-12-CTIL
- Conditions
- Other Tracheostomy Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 7 Nov 2012 (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.
Percutaneous tracheostomy is routinely performed in most intensive care units in the world.Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room.
In our institution as in a number of institutions in the country, it is acceptable to perform the operation by placing the tube on a high position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by palpation of the neck.
Using technological aids, such as direct sonography and bronchoscopy in real time may significantly reduce the rate of complications as a result of performing percutaneous tracheostomy.
So far, no systematic comparison has been made among the three methods.
Detailed description
Percutaneous tracheostomy is routinely performed in most intensive care units in the world in a number of indications, such as: airway obstruction, need for a long respiratory support, improvement in respiratory toilet, prophylaxis before head and neck procedures and cases of severe obstructive sleep apnea.
Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room.
In many places around the world it is customary in to perform the operation under the guidance of a bronchoscope to prevent damage to adjacent structures, high or low position of the tube, and damage to the posterior wall of the trachea and to approve the final position of the tube. However, the use of a bronchoscope depends on the availability of the equipment, knowledge of the operator, temporary occlusion of the trachea and hypercarbia, increased length of the procedure, and maintenance cost (disinfection, replacement, etc.).
Ultrasound that is performed before percutaneous procedure may be useful in preventing damage to para tracheal adjacent structures, and preventing high placement of the tube. The use of duplex sonography with real-time visualization of the needle path is done routinely in procedures such as central venous catheterization, and may improve the safety and accuracy of percutaneous tracheostomy without causing airway obstruction or hypercarbia. Feasibility of the procedure has been reviewed in an article by Rajajee et al .
In our institution as in a number of institutions in the country, it is acceptable to perform the operation by placing the tube on a high position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by palpation of the neck.
So far, no systematic comparison has been made among the three methods.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Direct laryngoscopy | Active comparator | Procedure: Percutaneous tracheostomyPerforming percutaneous tracheostomy as accepted in our institute: By placing the tube higher up near the vocal cords by direct laryngoscopy. In the second stage tracheal perforation by a needle will be carried out by palpation of the anatomical placement of the neck. |
| Real time sonography | Active comparator | Procedure: Percutaneous tracheostomyPercutaneous tracheostomy will be guided by real time sonography (with the visualization of the needle path) using acoustic shadows of the cricoid and the tracheal rings. In both methods, in order to identify the anatomic location of the needle prick- after passing the guide wire, the front elevation will be verified by optical means, which will be drawn out immediately afterwards. |
| Bronchoscopy | Active comparator | Procedure: Percutaneous tracheostomyPercutaneous tracheostomy will be guided by bronchoscopy. Initially, the tube will be placed according to the desired height observed by the bronchoscope, phase two will be tracheal perforation by a needle under trans illumination and real-time view on the income of the needle and the passage of the guide wire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All intubated patients with various injuries requiring percutaneous tracheostomy (in- house and out- house patients)
- Minimal age 18
Key exclusion criteria (2 listed)
- No patient consent for participation.
- Anatomical problem which does not allow for percutaneous tracheostomy and requires open procedure in the operating room.
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 tracheostomyThree methods of percutaneous tracheostomy | Procedure or surgery | Bronchoscopy, Direct laryngoscopy, Real time sonography |
Primary outcome
Systematic comparison
Time frame: 3 years
a systematic comparison among the three methods of percutaneous tracheostomy in terms of safety: minor and major periprocedural morbidity and mortality, up to 30 days.
1 secondary outcome
Minor morbidity
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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.
Patrick Sorkine, professor principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous tracheostomy in people with Other Tracheostomy Complication, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 2 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 14 Nov 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systematic comparison (time frame: 3 years). 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 14 Nov 2012.