ICU Patients Dependant on Mechanical Ventilation : Safest Mode of Performing Percutaneous Tracheostomy Among ICU Ventilated Unweanable PatientsNCT02754921
Percutaneous Dilatational Tracheostomy: Ultra-perc Versus Ciaglia Blue Dolphin
A study testing percutaneous dilatational tracheostomy using Ultra-Perc and Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin in people with ICU Patients Dependant on Mechanical Ventilation : Safest Mode of Performing Percutaneous Tracheostomy Among ICU Ventilated Unweanable Patients, run by Mohamed Sayed Mohamed Abbas.
Trial summary
The aim of this study is to compare Ultra-perc single stage dilator technique with Ciaglia Blue Dolphin ballon dilatation technique for intubated unweanable ICU patients with respect to procedure difficulties and complications. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- ICU Patients Dependant on Mechanical Ventilation : Safest Mode of Performing Percutaneous Tracheostomy Among ICU Ventilated Unweanable Patients
- What is being tested?
- percutaneous dilatational tracheostomy using Ultra-Perc and Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sepsis
- cerebrovascular accidents
- cervical cord injury
- traumatic brain injury
- post arrest and chronic obstructive pulmonary disease
Who cannot join
- patient or family refusal
- emergency tracheostomy
- distorted abnormal anatomy
- bleeding diathesis
- morbid obesity
- previous tracheostomy
- infected surgical site
- Adult respiratory distress syndrome patients requiring high positive end expiratory pressure and high oxygen demands
About this study
Official title: Percutaneous Dilatational Tracheostomy: Ultra-perc Single Stage Dilator Technique Versus Ciaglia Blue Dolphin Ballon Dilatation Technique for Intubated Unweanable ICU Patients
The aim of this study is to compare Ultra-perc single stage dilator technique with Ciaglia Blue Dolphin ballon dilatation technique for intubated unweanable ICU patients with respect to procedure difficulties and complications.
Read the detailed description
The investigators conducted a prospective randomized trial to compare Ultra-perc single stage dilator technique (UP) and Ciaglia Blue Dolphin ballon dilatation technique (CBD) From January 2013 to December 2015.
The investigators compared the two groups as regards Procedure difficulties including difficult dilatation, difficult tube insertion, failed tube insertion, false passage and tracheal stoma over dilatation. and Procedure complications including cardiac arrest, pneumothorax, pneumomediastinum, subcutaneous emphysema, hemorrhage and lung atelectasis.
- Being tested
- percutaneous dilatational tracheostomy using Ultra-Perc, Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous dilatational tracheostomy using Ultra-PercProcedure or surgery
Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ultra-Perc
Percutaneous dilatational tracheostomy using Ciaglia Blue DolphinProcedure or surgery
Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin
| Study group | Role | What they receive |
|---|---|---|
| Ultra-perc | Experimental | Not described Receives: Procedure: percutaneous dilatational tracheostomy using Ultra-Perc |
| Ciaglia Blue Dolphin | Experimental | Not described Receives: Procedure: Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure difficulties including difficult dilatation, difficult tube insertion, failed tube insertion, false passage and tracheal stoma over dilatation.
Measured: within 2 years
Procedure complications including cardiac arrest, pneumothorax, pneumomediastinum, subcutaneous emphysema, hemorrhage and lung atelectasis.
Measured: within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2015
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 ICU Patients Dependant on Mechanical Ventilation : Safest Mode of Performing Percutaneous Tracheostomy Among ICU Ventilated Unweanable PatientsStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Sayed Mohamed Abbas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Sayed Mohamed Abbas, Al Mouwasat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754921
- Sponsor's protocol ID
- MSAT-2
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Cianchi G, Zagli G, Bonizzoli M, Batacchi S, Cammelli R, Biondi S, Spina R, Peris A. Comparison between single-step and balloon dilatational tracheostomy in intensive care unit: a single-centre, randomized controlled study. Br J Anaesth. 2010 Jun;104(6):728-32. doi: 10.1093/bja/aeq087. Epub 2010 Apr 21.
PubMed 20413380
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Dilatational Tracheostomy: Ultra-perc Single Stage Dilator Technique Versus Ciaglia Blue Dolphin Ballon Dilatation Technique for Intubated Unweanable ICU Patients
- ClinicalTrials.gov ID
- NCT02754921
- Acronym / sponsor ID
- MSAT-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mohamed Sayed Mohamed AbbasUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- First posted
- 28 Apr 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.
The aim of this study is to compare Ultra-perc single stage dilator technique with Ciaglia Blue Dolphin ballon dilatation technique for intubated unweanable ICU patients with respect to procedure difficulties and complications.
Detailed description
The investigators conducted a prospective randomized trial to compare Ultra-perc single stage dilator technique (UP) and Ciaglia Blue Dolphin ballon dilatation technique (CBD) From January 2013 to December 2015.
The investigators compared the two groups as regards Procedure difficulties including difficult dilatation, difficult tube insertion, failed tube insertion, false passage and tracheal stoma over dilatation. and Procedure complications including cardiac arrest, pneumothorax, pneumomediastinum, subcutaneous emphysema, hemorrhage and lung atelectasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra-perc | Experimental | Procedure: percutaneous dilatational tracheostomy using Ultra-Perc |
| Ciaglia Blue Dolphin | Experimental | Procedure: Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- sepsis
- cerebrovascular accidents
- cervical cord injury
- traumatic brain injury
- post arrest and chronic obstructive pulmonary disease
Key exclusion criteria (8 listed)
- patient or family refusal
- emergency tracheostomy
- distorted abnormal anatomy
- bleeding diathesis
- morbid obesity
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 dilatational tracheostomy using Ultra-PercProcedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ultra-Perc | Procedure or surgery | Ultra-perc |
| Percutaneous dilatational tracheostomy using Ciaglia Blue DolphinProcedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin | Procedure or surgery | Ciaglia Blue Dolphin |
Primary outcome
Procedure difficulties including difficult dilatation, difficult tube insertion, failed tube insertion, false passage and tracheal stoma over dilatation.
Time frame: within 2 years
Procedure complications including cardiac arrest, pneumothorax, pneumomediastinum, subcutaneous emphysema, hemorrhage and lung atelectasis.
Time frame: within 2 years
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 28 Apr 2016.
- Results publication: PubMed 20413380Cianchi G, Zagli G, Bonizzoli M, Batacchi S, Cammelli R, Biondi S, Spina R, Peris A. Comparison between single-step and balloon dilatational tracheostomy in intensive care unit: a single-centre, randomized controlled study. Br J Anaesth. 2010 Jun;104(6):728-32. doi: 10.1093/bja/aeq087. Epub 2010 Apr 21.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous dilatational tracheostomy using Ultra-Perc and Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin in people with ICU Patients Dependant on Mechanical Ventilation : Safest Mode of Performing Percutaneous Tracheostomy Among ICU Ventilated Unweanable Patients, run by Mohamed Sayed Mohamed Abbas.
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 5 inclusion and 8 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 28 Apr 2016. 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 difficulties including difficult dilatation, difficult tube insertion, failed tube insertion, false passage and tracheal stoma over dilatation. (time frame: within 2 years). The study lists 2 primary outcomes in all. 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 NCT02754921, 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 28 Apr 2016.