Tracheostomy ComplicationNCT04637932
Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask
A study testing Percutaneous Dilatation Tracheostomy in people with Tracheostomy Complication, run by Eylem Yaşar at 1 site in Turkey (Türkiye).
Trial summary
In this study, our primary goal is to compare whether there is any difference in the complication of using pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure. Our secondary goal is to compare in terms of processing time. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tracheostomy Complication
- What is being tested?
- Percutaneous Dilatation Tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2020to 20 May 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- history of cervical trauma,
- high-pressure mechanical ventilation (inspiratory pressure above 40 cmH2O),
- pulmonary edema,
- acute respiratory distress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy
In this study, our primary goal is to compare whether there is any difference in the complication of using pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure. Our secondary goal is to compare in terms of processing time.
Read the detailed description
Following the approval of Muğla Sıtkı Koçman University Clinical Research Ethics Committee, 61 cases over the age of 18 who were scheduled for elective percutaneous dilatation tracheostomy in intensive care units were included in the study.
Elective percutaneous dilatation tracheostomy cases were randomly divided into two groups. Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.
In the endotracheal tube group, which is a conventional method, after entering the trachea with percutaneous technique, the intubation tube was removed before dilatation and percutaneous dilatation tracheostomy was performed with the Seldinger method.
In the pro-seal laryngeal mask group, the fiberoptic bronchoscope was advanced with a pro-seal laryngeal mask, and after the correct position was achieved, percutaneous dilatation tracheostomy was performed using the Seldinger Method.
Arterial blood pressure, oxygen saturation, heart rate, arterial blood gas, mechanical ventilation mode, positive end expiratory pressure and mean airway pressure values were recorded before and 30 minutes after the procedure.
The time until the end of the procedure and complications were determined.
- Conditions
- Tracheostomy Complication
- Being tested
- Percutaneous Dilatation Tracheostomy
- Keywords
- percutan tracheostomy, bronchoscopy, pro-seal Laryngeal mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Dilatation TracheostomyProcedure or surgery
Also called Bronchoscopy
pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Use of endotracheal tube During Percutaneous Dilatation Tracheostomy | Active comparator | Group 1 was determined as endotracheal tube Receives: Procedure: Percutaneous Dilatation Tracheostomy |
| Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy | Active comparator | group 2 as pro-seal laryngeal mask group. Receives: Procedure: Percutaneous Dilatation Tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication of percutan dilatation tracheostomy procedure.
blood gas analysis, physical examination, lung auscultation, hemodynamics parameters
Measured: 7 days
Secondary outcomes (1)
processing time.
Our secondary goal is to compare in terms of processing time.
Measured: minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start20 Nov 2020
- Primary completion20 Apr 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eylem Yaşar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eylem Yaşar, Muğla Sıtkı Koçman University
- Investigators
- semra Demirbilek, Study director, Mugla Sitki Kocman University Department of AnesthesiaDepartment of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637932
- Sponsor's protocol ID
- 2020/60
- Status last verified
- Dec 2021
- First submitted
- 3 Nov 2020
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy
- ClinicalTrials.gov ID
- NCT04637932
- Acronym / sponsor ID
- 2020/60
- Conditions
- Tracheostomy Complication
- Keywords
- percutan tracheostomy, bronchoscopy, pro-seal Laryngeal mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Eylem YaşarUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- 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.
In this study, our primary goal is to compare whether there is any difference in the complication of using pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure. Our secondary goal is to compare in terms of processing time.
Detailed description
Following the approval of Muğla Sıtkı Koçman University Clinical Research Ethics Committee, 61 cases over the age of 18 who were scheduled for elective percutaneous dilatation tracheostomy in intensive care units were included in the study.
Elective percutaneous dilatation tracheostomy cases were randomly divided into two groups. Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.
In the endotracheal tube group, which is a conventional method, after entering the trachea with percutaneous technique, the intubation tube was removed before dilatation and percutaneous dilatation tracheostomy was performed with the Seldinger method.
In the pro-seal laryngeal mask group, the fiberoptic bronchoscope was advanced with a pro-seal laryngeal mask, and after the correct position was achieved, percutaneous dilatation tracheostomy was performed using the Seldinger Method.
Arterial blood pressure, oxygen saturation, heart rate, arterial blood gas, mechanical ventilation mode, positive end expiratory pressure and mean airway pressure values were recorded before and 30 minutes after the procedure.
The time until the end of the procedure and complications were determined.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.
| Arm | Type | Receives |
|---|---|---|
| Use of endotracheal tube During Percutaneous Dilatation Tracheostomy | Active comparator | Procedure: Percutaneous Dilatation TracheostomyGroup 1 was determined as endotracheal tube |
| Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy | Active comparator | Procedure: Percutaneous Dilatation Tracheostomygroup 2 as pro-seal laryngeal mask group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- history of cervical trauma,
- high-pressure mechanical ventilation (inspiratory pressure above 40 cmH2O),
- pulmonary edema,
- acute respiratory distress
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 Dilatation TracheostomyAlso: Bronchoscopypro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure. | Procedure or surgery | Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy, Use of endotracheal tube During Percutaneous Dilatation Tracheostomy |
Primary outcome
complication of percutan dilatation tracheostomy procedure.
Time frame: 7 days
blood gas analysis, physical examination, lung auscultation, hemodynamics parameters
1 secondary outcome
processing time.
Time frame: 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 14 Dec 2021.
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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.
semra Demirbilek study director
Mugla Sitki Kocman University Department of AnesthesiaDepartment of Anesthesia
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 Dilatation Tracheostomy in people with Tracheostomy Complication, run by Eylem Yaşar at 1 site in Turkey (Türkiye).
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 0 inclusion and 4 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 14 Dec 2021. 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 Turkey (Türkiye). 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?
complication of percutan dilatation tracheostomy procedure. (time frame: 7 days). 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 Dec 2021.