TracheostomyNCT02469909
Comparison Between Immediate and Gradual Decannulation
A study testing Overnight observation, Pre-discharge evaluation and outpatient clinic follow ups in people with Tracheostomy, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
The investigators propose to examine the feasibility and safety of immediate (single stage) decannulation in adult patients in a controlled randomized trial. Patients who will be found fit for decannulation after an otolaryngologist and intensive care specialist assessment will be randomized into two groups: immediate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy
- What is being tested?
- Overnight observation, Pre-discharge evaluation and outpatient clinic follow ups
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2015to Jan 2019
- 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
- Patients who underwent tracheostomy with the following conditions:
- Tracheostomy tract is established more than 7 days
- Normal vital signs: heart rate 50-100, 90<systolic BP <180, respiratory rate <20. Saturation >90% in room air
- Effective cough
- Normal swallows \ feeding possibility
- # steps endoscopy test: through the tracheostomy tube, normal naso-laryngeal and through the tract with an upper look towards the subglottic area in order to detect subglottic stenosis.
- Ability of the patient to breath with a capped cannula.
Who cannot join
- Patients with a major complication in tracheostomy procedure (subcutaneous emphysema, pneumothorax, bleeding, false root)
- patient with anatomical neck abnormality
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Kaplan medical center
Rehovot, Rehovot
Oded Cohen, Dr, +972-54-468-2490, odedco@clalit.org.il
Yaara Haimovich, +972-528580806, yaaraha@clalit.org.il
About this study
Official title: Feasibility and Safety of Immediate Versus Gradual Decannulation: a Randomised Control Trial
The investigators propose to examine the feasibility and safety of immediate (single stage) decannulation in adult patients in a controlled randomized trial. Patients who will be found fit for decannulation after an otolaryngologist and intensive care specialist assessment will be randomized into two groups: immediate decannulation and gradual decrease in cannula size. Both groups of patients will be monitored after decannulation and in the outpatient clinic for any complications following the procedure.
Read the detailed description
Recruitment of the patients will be demands for decannulation evaluation of different departments in our institution. All patients who will agree to participate in the study and meet the inclusion criteria would undergo three major steps"
- Pre decannulation evaluation by otolaryngologist and intensive care specialist following inclusion criteria.
- Decannulation: In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient. In the gradual decannulation group: The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation.
- Follow up:
All patients would be followed in 7, 30, 90 days following decannulation in the outpatient clinic or in their departments if still hospitalized. In these visit questionnaires regarding possible respiratory complications will be documented.
- Conditions
- Tracheostomy
- Being tested
- Overnight observation, Pre-discharge evaluation, outpatient clinic follow ups, immediate decannulation, Gradual tracheostomy tube decrease
- Keywords
- Decannulation, tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overnight observationOther
patients in the immediate decannulation group would be admitted for an overnight in intensive care unit or the otolaryngology department. they would be monitored for any respiratory or airway complications.
Pre-discharge evaluationOther
After an overnight observation, patients in the immediate decannulation group would would undergo clinical and laboratory evaluation including vital signs and blood gases.
outpatient clinic follow upsOther
all patients would visit the otolaryngology outpatient clinic in 7, 30 and 90 days following decannulation for an evaluation of any respiratory complications following decannulation
immediate decannulationProcedure or surgery
the tracheostomy tube is removed at once
Gradual tracheostomy tube decreaseProcedure or surgery
The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation
| Study group | Role | What they receive |
|---|---|---|
| immediate decannulation | Other | In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient Receives: Other: Overnight observation; Other: Pre-discharge evaluation; Other: outpatient clinic follow ups; Procedure: immediate decannulation |
| Gradual tracheostomy tube decrease | Other | In the gradual decannulation group The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation Receives: Other: outpatient clinic follow ups; Procedure: Gradual tracheostomy tube decrease |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-insertion of the tracheostomy tube
number of patients who needed re-insertion of the tracheostomy tube due to respiratory distress within 7 days of decannulation
Measured: 7 days
mechanical ventilation
number of patients who needed mechanical ventilation due to respiratory distress within 7 days of decannulation
Measured: 7 days
Secondary outcomes (3)
Death from any cause
number of patients who died from any cause within 90 days of decannulation
Measured: 90 days
Respiratory distress
number of patients who reported difficulty breathing suggestive of stridor or by examination or intervention within 90 days of decannulation
Measured: up to 90 fays following decannulation
Pneumonia
number of patients who had a diagnosis of pneumonia in the period of 90 days following decannulation
Measured: 90 days following decannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Soroka University Medical Center
- Responsible party
- Principal investigator, Dr Oded Cohen, Kaplan Medical Center
- Investigators
- Nili Segal, Dr, Principal investigator, Soroka hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469909
- Sponsor's protocol ID
- ENTK 34-CTIL
- Status last verified
- Feb 2017
- First submitted
- 4 Jun 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Epstein SK. Anatomy and physiology of tracheostomy. Respir Care. 2005 Apr;50(4):476-82.
PubMed 15807905Delaney A, Bagshaw SM, Nalos M. Percutaneous dilatational tracheostomy versus surgical tracheostomy in critically ill patients: a systematic review and meta-analysis. Crit Care. 2006;10(2):R55. doi: 10.1186/cc4887.
PubMed 16606435Pierson DJ. Tracheostomy and weaning. Respir Care. 2005 Apr;50(4):526-33.
PubMed 15807916Christopher KL. Tracheostomy decannulation. Respir Care. 2005 Apr;50(4):538-41.
PubMed 15807918Heffner JE. The technique of weaning from tracheostomy. Criteria for weaning; practical measures to prevent failure. J Crit Illn. 1995 Oct;10(10):729-33.
PubMed 10155745Lewarski JS. Long-term care of the patient with a tracheostomy. Respir Care. 2005 Apr;50(4):534-7.
PubMed 15807917Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, Brown CA 3rd, Brandt C, Deakins K, Hartnick C, Merati A. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013 Jan;148(1):6-20. doi: 10.1177/0194599812460376. Epub 2012 Sep 18.
PubMed 22990518De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Association of Cardiothoracic Surgery. Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27.
PubMed 17588767
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Immediate Versus Gradual Decannulation: a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT02469909
- Acronym / sponsor ID
- ENTK 34-CTIL
- Conditions
- Tracheostomy
- Keywords
- Decannulation, tracheostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Collaborators
- Soroka University Medical Center
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 12 Jun 2015 (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 investigators propose to examine the feasibility and safety of immediate (single stage) decannulation in adult patients in a controlled randomized trial. Patients who will be found fit for decannulation after an otolaryngologist and intensive care specialist assessment will be randomized into two groups: immediate decannulation and gradual decrease in cannula size. Both groups of patients will be monitored after decannulation and in the outpatient clinic for any complications following the procedure.
Detailed description
Recruitment of the patients will be demands for decannulation evaluation of different departments in our institution. All patients who will agree to participate in the study and meet the inclusion criteria would undergo three major steps"
- Pre decannulation evaluation by otolaryngologist and intensive care specialist following inclusion criteria.
- Decannulation: In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient. In the gradual decannulation group: The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation.
- Follow up:
All patients would be followed in 7, 30, 90 days following decannulation in the outpatient clinic or in their departments if still hospitalized. In these visit questionnaires regarding possible respiratory complications will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate decannulation | Other | Other: Overnight observation, Other: Pre-discharge evaluation, Other: outpatient clinic follow ups, Procedure: immediate decannulationIn the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient |
| Gradual tracheostomy tube decrease | Other | Other: outpatient clinic follow ups, Procedure: Gradual tracheostomy tube decreaseIn the gradual decannulation group The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Tracheostomy tract is established more than 7 days
- Normal vital signs: heart rate 50-100, 90<systolic BP <180, respiratory rate <20. Saturation >90% in room air
- Effective cough
- Normal swallows \ feeding possibility
- # steps endoscopy test: through the tracheostomy tube, normal naso-laryngeal and through the tract with an upper look towards the subglottic area in order to detect subglottic stenosis.
Key exclusion criteria (3 listed)
- Patients with a major complication in tracheostomy procedure (subcutaneous emphysema, pneumothorax, bleeding, false root)
- patient with anatomical neck abnormality
- Pregnant women
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 |
|---|---|---|
| Overnight observationpatients in the immediate decannulation group would be admitted for an overnight in intensive care unit or the otolaryngology department. they would be monitored for any respiratory or airway complications. | Other | immediate decannulation |
| Pre-discharge evaluationAfter an overnight observation, patients in the immediate decannulation group would would undergo clinical and laboratory evaluation including vital signs and blood gases. | Other | immediate decannulation |
| outpatient clinic follow upsall patients would visit the otolaryngology outpatient clinic in 7, 30 and 90 days following decannulation for an evaluation of any respiratory complications following decannulation | Other | Gradual tracheostomy tube decrease, immediate decannulation |
| immediate decannulationthe tracheostomy tube is removed at once | Procedure or surgery | immediate decannulation |
| Gradual tracheostomy tube decreaseThe tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation | Procedure or surgery | Gradual tracheostomy tube decrease |
Primary outcome
re-insertion of the tracheostomy tube
Time frame: 7 days
number of patients who needed re-insertion of the tracheostomy tube due to respiratory distress within 7 days of decannulation
mechanical ventilation
Time frame: 7 days
number of patients who needed mechanical ventilation due to respiratory distress within 7 days of decannulation
3 secondary outcomes
Death from any cause
Time frame: 90 days
Respiratory distress
Time frame: up to 90 fays following decannulation
Pneumonia
Time frame: 90 days following decannulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Background: PubMed 15807905Epstein SK. Anatomy and physiology of tracheostomy. Respir Care. 2005 Apr;50(4):476-82.
- Background: PubMed 16606435Delaney A, Bagshaw SM, Nalos M. Percutaneous dilatational tracheostomy versus surgical tracheostomy in critically ill patients: a systematic review and meta-analysis. Crit Care. 2006;10(2):R55. doi: 10.1186/cc4887.
- Background: PubMed 15807916Pierson DJ. Tracheostomy and weaning. Respir Care. 2005 Apr;50(4):526-33.
- Background: PubMed 15807918Christopher KL. Tracheostomy decannulation. Respir Care. 2005 Apr;50(4):538-41.
- Background: PubMed 10155745Heffner JE. The technique of weaning from tracheostomy. Criteria for weaning; practical measures to prevent failure. J Crit Illn. 1995 Oct;10(10):729-33.
- Background: PubMed 15807917Lewarski JS. Long-term care of the patient with a tracheostomy. Respir Care. 2005 Apr;50(4):534-7.
- Results publication: PubMed 22990518Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, Brown CA 3rd, Brandt C, Deakins K, Hartnick C, Merati A. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013 Jan;148(1):6-20. doi: 10.1177/0194599812460376. Epub 2012 Sep 18.
- Results publication: PubMed 17588767De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Association of Cardiothoracic Surgery. Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27.
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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.
Nili Segal, Dr principal investigator
Soroka hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overnight observation, Pre-discharge evaluation and outpatient clinic follow ups in people with Tracheostomy, run by Kaplan 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 7 inclusion and 3 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 3 Mar 2017. 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?
Contact Oded Cohen, Dr (+972-544682490, oded915@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
re-insertion of the tracheostomy tube (time frame: 7 days). 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 NCT02469909, which also lists 8 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 3 Mar 2017.