DysphagiaPhase 2NCT01496924
Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU
A Phase 2 study testing speech therapy in people with Dysphagia, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
There is an association between increased risk of oropharyngeal dysphagia and artificial ventilation through endotracheal tube, followed by tracheostomy. The aim of the present study is to analyze the outcomes of an early swallowing rehabilitation program of dysphagic tracheostomized patients under mechanical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- speech therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Jun 2012
- Phase
- Phase 2
- 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
- admission in an ICU
- mechanical ventilation and tracheostomy for at least 48 hours
- appropriate level of consciousness (Glasgow coma scale ≥ 11)
- hemodynamic stability without need for vasoactive drugs
- minimum mechanical ventilation parameters characterized by pressure support ventilation (PSV) ≤ 20 cm H2O, positive end-expiratory pressure (PEEP) ≤ 8 cm H2O, fraction of inspired oxygen (FiO2) ≤ 50 and respiratory rate ≤ 30 inspirations per minute.
Who cannot join
- surgery with resection of structures of oral cavity, pharynx, larynx and/or esophagus
- nasal fracture or skull base fracture preventing otorhinolaryngological exam
- possible surgical treatment after ICU admission with no reasonable time for carrying out the planned intervention
- degenerative diseases characterized by outbreaks and remissions
- past history of oropharyngeal dysphagia
- previous speech therapy
Show all 11Show fewer
- excessive amount of thick tracheal secretion requiring frequent tracheal suctioning
- end-stage of chronic obstructive pulmonary disease
- tracheoesophageal fistula
- allergy to dyes
- low survival expectancy.
Trial locations and contacts
1 site in 1 country.
Maria Inez Goncalves, PHD contact
Brazil1 site, 1 recruiting
- Recruiting
Intensive Care Unit - Hospital Sao Paulo
São Paulo, São Paulo, 04024900
Katia Alonso, PHD, 55 11 92119858
Katia Alonso, PHD
About this study
Official title: Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at Intensive Care Unit
There is an association between increased risk of oropharyngeal dysphagia and artificial ventilation through endotracheal tube, followed by tracheostomy. The aim of the present study is to analyze the outcomes of an early swallowing rehabilitation program of dysphagic tracheostomized patients under mechanical ventilation at the intensive care unit.
Read the detailed description
This prospective study will be conduct in seven intensive care units of the university public hospital Inclusion criteria are: patients under mechanical ventilation and tracheostomy for at least 48 hours, appropriate level of consciousness (Glasgow coma scale ≥ 11), hemodynamic stability without need for vasoactive drugs; minimum mechanical ventilation parameters characterized by: pressure support ventilation (PSV) ≤ 20 cm H2O, positive end-expiratory pressure (PEEP) ≤ 8 cm H2O, fraction of inspired oxygen (FiO2) ≤ 50 and respiratory rate ≤ 30 inspirations per minute. Primary exclusion criteria are: patients who underwent surgery with resection of structures of oral cavity, pharynx, larynx and/or esophagus; nasal fracture or skull base fracture preventing otorhinolaryngological exam; possible surgical treatment after ICU admission with no reasonable time for carrying out the planned intervention; degenerative diseases characterized by outbreaks and remissions; past history of oropharyngeal dysphagia, previous speech therapy, excessive amount of thick tracheal secretion requiring frequent tracheal suctioning, end-stage of chronic obstructive pulmonary disease, tracheoesophageal fistula, allergy to dyes, and low survival expectancy.
The study consist of three stages: (1) sample selection with a test of the speaking valve and initial assessments, (2) swallowing rehabilitation and (3) post-treatment reassessments. Clinical assessments will be performed by speech-pathologists and otorhinolaryngologists with patients under mechanical ventilation. Subsequently, patients with dysphagia will be submitted to a rehabilitation program with standardized intervention, followed by a new assessment of abnormalities. The efficacy of swallowing treatment will be assessed by comparing the scores before and after treatment. Paired Student's test or Wilcoxon-test will be applied, according to data distribution. Categorical variables will be expressed as number and percentage and analyzed through McNemar test. All p-values will be two-sided and a p-value < 0.05 considered statistically significant.
- Conditions
- Dysphagia
- Being tested
- speech therapy
- Keywords
- Dysphagia, Intensive care units, Deglutition disorders, Rehabilitation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech therapyOther
A single oral-motor technique will be used in a 10-times series intercalated with rest. Swallowing training techniques comprised indirect therapy (swallowing of saliva) and direct therapy (swallowing of food).
| Study group | Role | What they receive |
|---|---|---|
| speech therapy group | Other | All dysphagic patients will be submitted to speech therapy Receives: Other: speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
dysphagia improvement
Otorhinolaryngological assessment will be carried out before and after treatment by means of a bedside video nasal endoscopic examination of swallowing, and included the evaluation of the following aspects: mobility of vocal folds, saliva and food swallowing, swallowing trigger time, food stasis in pharyngeal recesses, laryngeal penetration, tracheal aspiration, pharyngeal clearance after swallowing, laryngeal sensitivity and cough reflex, both by the speech-language pathologist and the otorrhinolaryngologist
Measured: participants will be followed for the duration of ICU stay, an expected average of 2 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startJan 2008
- Primary completionJan 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 DysphagiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katia Alonso Rodrigues, Federal University of São Paulo
- Investigators
- Katia Alonso, PHD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496924
- Sponsor's protocol ID
- CEP1802/06
- Status last verified
- Dec 2011
- First submitted
- 21 Nov 2011
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01496924
- Acronym / sponsor ID
- CEP1802/06
- Conditions
- Dysphagia
- Keywords
- Dysphagia, Intensive care units, Deglutition disorders, Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 21 Dec 2011 (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.
There is an association between increased risk of oropharyngeal dysphagia and artificial ventilation through endotracheal tube, followed by tracheostomy. The aim of the present study is to analyze the outcomes of an early swallowing rehabilitation program of dysphagic tracheostomized patients under mechanical ventilation at the intensive care unit.
Detailed description
This prospective study will be conduct in seven intensive care units of the university public hospital Inclusion criteria are: patients under mechanical ventilation and tracheostomy for at least 48 hours, appropriate level of consciousness (Glasgow coma scale ≥ 11), hemodynamic stability without need for vasoactive drugs; minimum mechanical ventilation parameters characterized by: pressure support ventilation (PSV) ≤ 20 cm H2O, positive end-expiratory pressure (PEEP) ≤ 8 cm H2O, fraction of inspired oxygen (FiO2) ≤ 50 and respiratory rate ≤ 30 inspirations per minute. Primary exclusion criteria are: patients who underwent surgery with resection of structures of oral cavity, pharynx, larynx and/or esophagus; nasal fracture or skull base fracture preventing otorhinolaryngological exam; possible surgical treatment after ICU admission with no reasonable time for carrying out the planned intervention; degenerative diseases characterized by outbreaks and remissions; past history of oropharyngeal dysphagia, previous speech therapy, excessive amount of thick tracheal secretion requiring frequent tracheal suctioning, end-stage of chronic obstructive pulmonary disease, tracheoesophageal fistula, allergy to dyes, and low survival expectancy.
The study consist of three stages: (1) sample selection with a test of the speaking valve and initial assessments, (2) swallowing rehabilitation and (3) post-treatment reassessments. Clinical assessments will be performed by speech-pathologists and otorhinolaryngologists with patients under mechanical ventilation. Subsequently, patients with dysphagia will be submitted to a rehabilitation program with standardized intervention, followed by a new assessment of abnormalities. The efficacy of swallowing treatment will be assessed by comparing the scores before and after treatment. Paired Student's test or Wilcoxon-test will be applied, according to data distribution. Categorical variables will be expressed as number and percentage and analyzed through McNemar test. All p-values will be two-sided and a p-value < 0.05 considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| speech therapy group | Other | Other: speech therapyAll dysphagic patients will be submitted to speech therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- admission in an ICU
- mechanical ventilation and tracheostomy for at least 48 hours
- appropriate level of consciousness (Glasgow coma scale ≥ 11)
- hemodynamic stability without need for vasoactive drugs
- minimum mechanical ventilation parameters characterized by pressure support ventilation (PSV) ≤ 20 cm H2O, positive end-expiratory pressure (PEEP) ≤ 8 cm H2O, fraction of inspired oxygen (FiO2) ≤ 50 and respiratory rate ≤ 30 inspirations per minute.
Key exclusion criteria (11 listed)
- surgery with resection of structures of oral cavity, pharynx, larynx and/or esophagus
- nasal fracture or skull base fracture preventing otorhinolaryngological exam
- possible surgical treatment after ICU admission with no reasonable time for carrying out the planned intervention
- degenerative diseases characterized by outbreaks and remissions
- past history of oropharyngeal dysphagia
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 |
|---|---|---|
| speech therapyA single oral-motor technique will be used in a 10-times series intercalated with rest. Swallowing training techniques comprised indirect therapy (swallowing of saliva) and direct therapy (swallowing of food). | Other | speech therapy group |
Primary outcome
dysphagia improvement
Time frame: participants will be followed for the duration of ICU stay, an expected average of 2 weeks"
Otorhinolaryngological assessment will be carried out before and after treatment by means of a bedside video nasal endoscopic examination of swallowing, and included the evaluation of the following aspects: mobility of vocal folds, saliva and food swallowing, swallowing trigger time, food stasis in pharyngeal recesses, laryngeal penetration, tracheal aspiration, pharyngeal clearance after swallowing, laryngeal sensitivity and cough reflex, both by the speech-language pathologist and the otorrhinolaryngologist
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 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.
Maria Inez Goncalves, PHD contact
Katia Alonso, PHD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing speech therapy in people with Dysphagia, run by Federal University of São Paulo at 1 site in Brazil.
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 11 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 21 Dec 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Katia Alonso, PHD (55 11 92119858, katiaalonso@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dysphagia improvement (time frame: participants will be followed for the duration of ICU stay, an expected average of 2 weeks"). 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 21 Dec 2011.