Tracheostomy ComplicationsNCT02656719
Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy
A study testing Ultrasound guided percutaneous tracheostomy and Bronchoscopy guided percutaneous tracheostomy in people with Tracheostomy Complications, run by Aykut Saritas.
Trial summary
Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Complications
- What is being tested?
- Ultrasound guided percutaneous tracheostomy and Bronchoscopy guided percutaneous tracheostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Sep 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 and mechanically ventilated patients indicated for a tracheostomy
Who cannot join
- Patients with tracheal or neck abnormalities, soft tissue infection in the neck, neck surgery history, oxygenation problems , coagulation disorders or coagulation parameter changes and those requiring urgent or surgery patients unable to provide informed consent.
About this study
Official title: Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Dilatational Tracheostomy for Safety, Complications and Efficiency in Critically Ill Patient
Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.
Read the detailed description
Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.
Patients will be randomly assigned to be submitted to evaluate safety, complication rates, easy to perform , clinical outcomes and effectivity.
- Conditions
- Tracheostomy Complications
- Being tested
- Ultrasound guided percutaneous tracheostomy, Bronchoscopy guided percutaneous tracheostomy
- Keywords
- tracheostomy, complications, ultrasound, bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided percutaneous tracheostomyDevice
Ultrasound guided percutaneous tracheostomy
Bronchoscopy guided percutaneous tracheostomyDevice
Bronchoscopy guided percutaneous tracheostomy
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Ultrasound guided percutaneous tracheostomy Receives: Device: Ultrasound guided percutaneous tracheostomy |
| Bronchoscopy | Active comparator | Bronchoscopy guided percutaneous tracheostomy Receives: Device: Bronchoscopy guided percutaneous tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure failure of ultrasound to provide this anatomical information and ease of perform
occurence of a major complications: bleeding, subcutaneous emphysema, oesophageal perforation, number of applied needle interventions, procedure duration, cardiorespiratory arrest
Measured: During percutaneous tracheostomy an expected average time 20 minutes
Secondary outcomes (7)
procedure time
the procedure duration was taken as the time that elapsed from the placement of the needle to the placement of the tracheostomy cannula.
Measured: during percutaneous tracheostomy ( average expected time 20 minutes)
Pneumothorax
Pneumothorax due to the percutaneous tracheostomy detected by clinical examination during the procedure or chest x-ray after the procedure.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Tracheal posterior wall injury
Tracheal posterior wall injury as detected by bronchoscopy after the procedure
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Accidental decannulation
Accidental decannulation after the procedure during Hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Cardiorespiratory arrest
Cardiorespiratory arrest due to percutaneous tracheostomy
Measured: during percutaneous tracheostomy an expected average of 20 minutes
Minor bleeding
Haemorrhage that could not be stopped by sponge wrapping the stoma after the procedure and/or blood coming with aspiration inside the tracheostomy tube was defined as minor bleeding
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Major bleeding
Continuous haemorrhage from the stoma and/or from the trachea with aspiration despite compresses was defined as a major haemorrhage.
Measured: During the procedure an expected average of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startAug 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tracheostomy ComplicationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aykut Saritas
- Sponsor type
- University, hospital or other
- Collaborators
- Prof.Dr.A.İlhan Özdemir State Hospital
- Responsible party
- Sponsor-investigator, Aykut Saritas, Tepecik Training and Research Hospital
- Investigators
- Aykut Saritas, MD, Principal investigator, İzmir Tepecik Training and Research Hospitalmuhammed murat kurnaz, MD, Study chair, Prof.Dr.A.İlhan Ozdemir State hospital Giresun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656719
- Sponsor's protocol ID
- 2014-1
- Status last verified
- Mar 2020
- First submitted
- 5 Jan 2016
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ravi PR, Vijay MN. Real time ultrasound-guided percutaneous tracheostomy: Is it a better option than bronchoscopic guided percutaneous tracheostomy? Med J Armed Forces India. 2015 Apr;71(2):158-64. doi: 10.1016/j.mjafi.2015.01.013. Epub 2015 Mar 12.
PubMed 25859079Gobatto AL, Besen BA, Tierno PF, Mendes PV, Cadamuro F, Joelsons D, Melro L, Park M, Malbouisson LM. Comparison between ultrasound- and bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients: a retrospective cohort study. J Crit Care. 2015 Feb;30(1):220.e13-7. doi: 10.1016/j.jcrc.2014.09.011. Epub 2014 Sep 22.
PubMed 25306240Flint AC, Midde R, Rao VA, Lasman TE, Ho PT. Bedside ultrasound screening for pretracheal vascular structures may minimize the risks of percutaneous dilatational tracheostomy. Neurocrit Care. 2009 Dec;11(3):372-6. doi: 10.1007/s12028-009-9259-z. Epub 2009 Aug 13.
PubMed 19680824
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Dilatational Tracheostomy for Safety, Complications and Efficiency in Critically Ill Patient
- ClinicalTrials.gov ID
- NCT02656719
- Acronym / sponsor ID
- 2014-1
- Conditions
- Tracheostomy Complications
- Keywords
- tracheostomy, complications, ultrasound, bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aykut SaritasUniversity, hospital or other
- Collaborators
- Prof.Dr.A.İlhan Özdemir State Hospital
- Study start
- Aug 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Jan 2016 (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.
Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.
Detailed description
Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.
Patients will be randomly assigned to be submitted to evaluate safety, complication rates, easy to perform , clinical outcomes and effectivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Device: Ultrasound guided percutaneous tracheostomyUltrasound guided percutaneous tracheostomy |
| Bronchoscopy | Active comparator | Device: Bronchoscopy guided percutaneous tracheostomyBronchoscopy guided percutaneous tracheostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All intubated and mechanically ventilated patients indicated for a tracheostomy
Key exclusion criteria (1 listed)
- Patients with tracheal or neck abnormalities, soft tissue infection in the neck, neck surgery history, oxygenation problems , coagulation disorders or coagulation parameter changes and those requiring urgent or surgery patients unable to provide informed consent.
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 |
|---|---|---|
| Ultrasound guided percutaneous tracheostomyUltrasound guided percutaneous tracheostomy | Device | Ultrasound |
| Bronchoscopy guided percutaneous tracheostomyBronchoscopy guided percutaneous tracheostomy | Device | Bronchoscopy |
Primary outcome
procedure failure of ultrasound to provide this anatomical information and ease of perform
Time frame: During percutaneous tracheostomy an expected average time 20 minutes
occurence of a major complications: bleeding, subcutaneous emphysema, oesophageal perforation, number of applied needle interventions, procedure duration, cardiorespiratory arrest
7 secondary outcomes
procedure time
Time frame: during percutaneous tracheostomy ( average expected time 20 minutes)
Pneumothorax
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Tracheal posterior wall injury
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Accidental decannulation
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Cardiorespiratory arrest
Time frame: during percutaneous tracheostomy an expected average of 20 minutes
Minor bleeding
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Major bleeding
Time frame: During the procedure an expected average of 20 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 10 Mar 2020.
- Background: PubMed 25859079Ravi PR, Vijay MN. Real time ultrasound-guided percutaneous tracheostomy: Is it a better option than bronchoscopic guided percutaneous tracheostomy? Med J Armed Forces India. 2015 Apr;71(2):158-64. doi: 10.1016/j.mjafi.2015.01.013. Epub 2015 Mar 12.
- Background: PubMed 25306240Gobatto AL, Besen BA, Tierno PF, Mendes PV, Cadamuro F, Joelsons D, Melro L, Park M, Malbouisson LM. Comparison between ultrasound- and bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients: a retrospective cohort study. J Crit Care. 2015 Feb;30(1):220.e13-7. doi: 10.1016/j.jcrc.2014.09.011. Epub 2014 Sep 22.
- Background: PubMed 19680824Flint AC, Midde R, Rao VA, Lasman TE, Ho PT. Bedside ultrasound screening for pretracheal vascular structures may minimize the risks of percutaneous dilatational tracheostomy. Neurocrit Care. 2009 Dec;11(3):372-6. doi: 10.1007/s12028-009-9259-z. Epub 2009 Aug 13.
- Individual participant dataSharing planned: Undecided
Related trials for Tracheostomy Complications
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
RecruitingObservational study
Increased Body Temperature Post Tracheostomy: a Retrospective Study
Tracheostomy Complication
RecruitingObservational study
Outcomes After Tracheal Cannula Removal
Tracheostomy
RecruitingObservational study
Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
Anesthesia Complication, Tracheostomy Complications
RecruitingObservational study
"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?"
Surveillance, Endoscopy
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.
Aykut Saritas, MD principal investigator
İzmir Tepecik Training and Research Hospital
muhammed murat kurnaz, MD study chair
Prof.Dr.A.İlhan Ozdemir State hospital Giresun
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided percutaneous tracheostomy and Bronchoscopy guided percutaneous tracheostomy in people with Tracheostomy Complications, run by Aykut Saritas.
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 1 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: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
procedure failure of ultrasound to provide this anatomical information and ease of perform (time frame: During percutaneous tracheostomy an expected average time 20 minutes). 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 NCT02656719, which also lists 3 linked publications.
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 10 Mar 2020.