Swallowing DisorderPhase 3NCT01268423
Early Percutaneous Tracheostomy and Swallowing Dysfunction
A Phase 3 study testing Percutaneous tracheostomy and Prolonged translaryngeal intubation in people with Swallowing Disorder, run by University of Chile at 1 site in Chile.
Trial summary
The aim of the study is to determine if performing an early tracheostomy (within the first 4 days of endotracheal intubation) in critically ill patients on mechanical ventilation, reduces the incidence of swallowing dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swallowing Disorder
- What is being tested?
- Percutaneous tracheostomy and Prolonged translaryngeal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChile
- Study dates
- Jan 2011to Jun 2012
- Phase
- Phase 3
- 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
- Written informed consent has been obtained for the procedure
- Patients whose need of mechanical ventilation is estimated in ≥ 7 days and require a percutaneous tracheostomy
Who cannot join
- Patients younger than 18 years old
- Patients with neurologic pathology
- Patients with dysphagia history
- Patients whose MV duration is estimated in < 7 days
- Patients with airway obstruction requiring an emergency tracheostomy
- Patients already having a tracheostomy in situ
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- Pregnancy
- Patients who have already been enrolled on another trial
- Patients with absolute contraindication to perform a percutaneous tracheostomy
- Patients with high risk of dying, life expectancy of < 48 hours
- Patients in whom limitation of therapy has been decided
- Family rejection to participate in the study
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan
Carlos M Romero, MD
About this study
Official title: Impact of Early Percutaneous Tracheostomy on the Incidence of Swallowing Dysfunction in Critically Ill Patients on Mechanical Ventilation. A Randomized Clinical Trial
The aim of the study is to determine if performing an early tracheostomy (within the first 4 days of endotracheal intubation) in critically ill patients on mechanical ventilation, reduces the incidence of swallowing dysfunction.
Read the detailed description
The development of initial resuscitation maneuvers, associated with a better knowledge of the physiopathology of critical illnesses and the technological development experienced by critical care medicine, allow us to give vital support to patients for long periods of time. In this scenario, a considerable proportion of critically ill patients may require translaryngeal intubation and invasive mechanical ventilation. Patients who require prolonged translaryngeal intubation have a high risk of developing swallowing dysfunction, a condition predisposing to secretions aspiration. Until now, there has been no demonstration of a causal association between the duration of translaryngeal intubation and development of swallowing dysfunction. However, all the studies about this topic have been performed on patients submitted to prolonged translaryngeal intubation. Clinical studies have documented the development of early laryngotracheal lesions after intubation, which might explain post extubation dysfunction of swallowing reflex, probably as consequence of alteration of mechanic and chemo-receptors of the pharyngeal and laryngeal mucosa. There are no studies evaluating the impact of an early percutaneous tracheostomy on the incidence of swallowing dysfunction in critical care patients. The investigators have documented a 38% of swallowing dysfunction in our critically ill patients submitted to prolonged mechanical ventilation. The hypothesis of the study is that performance of an early percutaneous tracheostomy, within the first 4 days of translaryngeal intubation, in critical care patients on mechanical ventilation, reduces the incidence of swallowing dysfunction. The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) by a trained otolaryngologist, 3 to 5 days after weaning of mechanical ventilation.
- Conditions
- Swallowing Disorder
- Being tested
- Percutaneous tracheostomy, Prolonged translaryngeal intubation
- Keywords
- Percutaneous tracheostomy, Swallowing dysfunction, Mechanical ventilation, Intensive Care
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous tracheostomyProcedure or surgery
Also called Percutaneous dilatational tracheostomy
Percutaneous tracheostomy within the first 4 days of mechanical ventilation.
Prolonged translaryngeal intubationProcedure or surgery
Also called Prolonged endotracheal intubation
Prolonged endotracheal intubation, and reevaluation at day 10 to establish the requirement of percutaneous tracheostomy. If clinical condition determines that the patient needs a percutaneous tracheostomy, this will be performed between days 11 and 14.
| Study group | Role | What they receive |
|---|---|---|
| Early percutaneous tracheostomy | Experimental | Not described Receives: Procedure: Percutaneous tracheostomy |
| Prolonged translaryngeal intubation | Active comparator | Not described Receives: Procedure: Prolonged translaryngeal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of swallowing dysfunction
The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) 3 to 5 days after weaning of mechanical ventilation.
Measured: 3 to 5 days after weaning of mechanical ventilation
Secondary outcomes (8)
Ventilator-free days
Measured: 28 days
Incidence of ventilator-associated pneumonia
Measured: 28 days
Delirium-free and coma-free days
Measured: 28 days
Daily dose of sedatives
Measured: 28 days
ICU-free days
Measured: 28 days
Critical Care Unit-free days
Length of stay at Critical Care Unit involve days of stay in thre Intensive Care Unit, plus the days of stay in the Intermediate Care Unit.
Measured: 90 days
Hospital length of stay
Measured: 90 days
All cause mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisorderStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Investigators
- Carlos M Romero, MD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268423
- Sponsor's protocol ID
- FONIS SA10I20012
- Status last verified
- Dec 2010
- First submitted
- 29 Dec 2010
- Last updated
- 5 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Percutaneous Tracheostomy on the Incidence of Swallowing Dysfunction in Critically Ill Patients on Mechanical Ventilation. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01268423
- Acronym / sponsor ID
- FONIS SA10I20012
- Conditions
- Swallowing Disorder
- Keywords
- Percutaneous tracheostomy, Swallowing dysfunction, Mechanical ventilation, Intensive Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 30 Dec 2010 (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 the study is to determine if performing an early tracheostomy (within the first 4 days of endotracheal intubation) in critically ill patients on mechanical ventilation, reduces the incidence of swallowing dysfunction.
Detailed description
The development of initial resuscitation maneuvers, associated with a better knowledge of the physiopathology of critical illnesses and the technological development experienced by critical care medicine, allow us to give vital support to patients for long periods of time. In this scenario, a considerable proportion of critically ill patients may require translaryngeal intubation and invasive mechanical ventilation. Patients who require prolonged translaryngeal intubation have a high risk of developing swallowing dysfunction, a condition predisposing to secretions aspiration. Until now, there has been no demonstration of a causal association between the duration of translaryngeal intubation and development of swallowing dysfunction. However, all the studies about this topic have been performed on patients submitted to prolonged translaryngeal intubation. Clinical studies have documented the development of early laryngotracheal lesions after intubation, which might explain post extubation dysfunction of swallowing reflex, probably as consequence of alteration of mechanic and chemo-receptors of the pharyngeal and laryngeal mucosa. There are no studies evaluating the impact of an early percutaneous tracheostomy on the incidence of swallowing dysfunction in critical care patients. The investigators have documented a 38% of swallowing dysfunction in our critically ill patients submitted to prolonged mechanical ventilation. The hypothesis of the study is that performance of an early percutaneous tracheostomy, within the first 4 days of translaryngeal intubation, in critical care patients on mechanical ventilation, reduces the incidence of swallowing dysfunction. The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) by a trained otolaryngologist, 3 to 5 days after weaning of mechanical ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early percutaneous tracheostomy | Experimental | Procedure: Percutaneous tracheostomy |
| Prolonged translaryngeal intubation | Active comparator | Procedure: Prolonged translaryngeal intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent has been obtained for the procedure
- Patients whose need of mechanical ventilation is estimated in ≥ 7 days and require a percutaneous tracheostomy
Key exclusion criteria (12 listed)
- Patients younger than 18 years old
- Patients with neurologic pathology
- Patients with dysphagia history
- Patients whose MV duration is estimated in < 7 days
- Patients with airway obstruction requiring an emergency tracheostomy
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 tracheostomyAlso: Percutaneous dilatational tracheostomyPercutaneous tracheostomy within the first 4 days of mechanical ventilation. | Procedure or surgery | Early percutaneous tracheostomy |
| Prolonged translaryngeal intubationAlso: Prolonged endotracheal intubationProlonged endotracheal intubation, and reevaluation at day 10 to establish the requirement of percutaneous tracheostomy. If clinical condition determines that the patient needs a percutaneous tracheostomy, this will be performed between days 11 and 14. | Procedure or surgery | Prolonged translaryngeal intubation |
Primary outcome
Incidence of swallowing dysfunction
Time frame: 3 to 5 days after weaning of mechanical ventilation
The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) 3 to 5 days after weaning of mechanical ventilation.
8 secondary outcomes
Ventilator-free days
Time frame: 28 days
Incidence of ventilator-associated pneumonia
Time frame: 28 days
Delirium-free and coma-free days
Time frame: 28 days
Daily dose of sedatives
Time frame: 28 days
ICU-free days
Time frame: 28 days
Critical Care Unit-free days
Time frame: 90 days
Hospital length of stay
Time frame: 90 days
All cause mortality
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2011.
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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.
Carlos M Romero, MD principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous tracheostomy and Prolonged translaryngeal intubation in people with Swallowing Disorder, run by University of Chile at 1 site in Chile.
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 12 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 5 Jan 2011. 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 Chile. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Carlos M Romero, MD (0562 - 9788264, caromero@redclinicauchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of swallowing dysfunction (time frame: 3 to 5 days after weaning of mechanical ventilation). 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 5 Jan 2011.