Swallowing DisorderNCT01618240
Predictors of the Ability to Protect the Airway in Long-term Ventilated Patients
An observational study of Swallowing Disorder and Aspiration, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
First part of a 2 part study with the same IRB protocol #, and labeled 'A'. Investigators hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the ability to protect the airway during swallowing in long-term ventilated subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swallowing Disorder, Aspiration, Long Term Ventilation
- What is being tested?
- Muscle Strength Measurement and Ventilator
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Long term ventilated and tracheostomized patients in the Respiratory Acute and Surgical Intensive Care Unit
Who may be able to join
- Patients admitted to the Respiratory Acute Care Unit and Surgical Intensive Care Unit, units with a mixed collection of long term ventilated patients in a major academic teaching hospital.
- Age over 18 years.
- Long-term ventilated patients (>10 days) with tracheotomies
Who cannot join
- Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.
- Non-cooperative patient, CAM score positive for delirium.
- For women: pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts general Hospital
Boston, Massachusetts, 02114
About this study
Official title: Determining Predictors of Adequate Upper Airway Function in Long-term Ventilated Patients
First part of a 2 part study with the same IRB protocol #, and labeled 'A'. Investigators hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the ability to protect the airway during swallowing in long-term ventilated subjects. More specifically, the investigators hypothesized that low muscle strength is associated with the inability to clear secretions from the peri-laryngeal area (valleculae and pyriform sinus residue scale (VPSR scale [NRS: 0-4] of > 1) and entering the materials into airway (PAS scale [1-8]> 1), which should predispose to endotracheal aspiration.
- Conditions
- Swallowing Disorder, Aspiration, Long Term Ventilation
- Being tested
- Muscle Strength Measurement, Ventilator
- Keywords
- FEES, PAS, VPSR, MRC
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Strength MeasurementOther
MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
VentilatorOther
A mechanical ventilator is used to assist or replace spontaneous breathing.
| Study group | Role | What they receive |
|---|---|---|
| Long term ventilated subjects | Muscle Strength Measurement, ventilator Receives: Other: Muscle Strength Measurement; Other: Ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients.
Measured: Within 24 hours of fiberoptic endoscopic evaluation of swallow
Secondary outcomes (1)
Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration
Measured: Within 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Eikermann, Massachusetts General Hospital
- Investigators
- Matthias Eikermann, MD, PhD, Principal investigator, MGH, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618240
- Sponsor's protocol ID
- 2010P001919A
- Status last verified
- May 2013
- First submitted
- 6 Jun 2012
- Last updated
- 13 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
PubMed 8721066Butler SG, Stuart A, Markley L, Rees C. Penetration and aspiration in healthy older adults as assessed during endoscopic evaluation of swallowing. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):190-8. doi: 10.1177/000348940911800306.
PubMed 19374150Kleyweg RP, van der Meche FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barre syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9. doi: 10.1002/mus.880141111.
PubMed 1745285Mirzakhani H, Williams JN, Mello J, Joseph S, Meyer MJ, Waak K, Schmidt U, Kelly E, Eikermann M. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013 Aug;119(2):389-97. doi: 10.1097/ALN.0b013e31829373fe.
PubMed 23584384
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Predictors of Adequate Upper Airway Function in Long-term Ventilated Patients
- ClinicalTrials.gov ID
- NCT01618240
- Acronym / sponsor ID
- 2010P001919A
- Conditions
- Swallowing Disorder, Aspiration, Long Term Ventilation
- Keywords
- FEES, PAS, VPSR, MRC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Posted 27 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First part of a 2 part study with the same IRB protocol #, and labeled 'A'. Investigators hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the ability to protect the airway during swallowing in long-term ventilated subjects. More specifically, the investigators hypothesized that low muscle strength is associated with the inability to clear secretions from the peri-laryngeal area (valleculae and pyriform sinus residue scale (VPSR scale [NRS: 0-4] of > 1) and entering the materials into airway (PAS scale [1-8]> 1), which should predispose to endotracheal aspiration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long term ventilated subjects | – | Other: Muscle Strength Measurement, Other: VentilatorMuscle Strength Measurement, ventilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Long term ventilated and tracheostomized patients in the Respiratory Acute and Surgical Intensive Care Unit
Key inclusion criteria (3 listed)
- Patients admitted to the Respiratory Acute Care Unit and Surgical Intensive Care Unit, units with a mixed collection of long term ventilated patients in a major academic teaching hospital.
- Age over 18 years.
- Long-term ventilated patients (>10 days) with tracheotomies
Key exclusion criteria (3 listed)
- Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.
- Non-cooperative patient, CAM score positive for delirium.
- For women: pregnancy.
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 |
|---|---|---|
| Muscle Strength MeasurementMRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement | Other | Long term ventilated subjects |
| VentilatorA mechanical ventilator is used to assist or replace spontaneous breathing. | Other | Long term ventilated subjects |
Primary outcome
Muscle Strength
Time frame: Within 24 hours of fiberoptic endoscopic evaluation of swallow
We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients.
1 secondary outcome
Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration
Time frame: Within 3 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8721066Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
- Background: PubMed 19374150Butler SG, Stuart A, Markley L, Rees C. Penetration and aspiration in healthy older adults as assessed during endoscopic evaluation of swallowing. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):190-8. doi: 10.1177/000348940911800306.
- Background: PubMed 1745285Kleyweg RP, van der Meche FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barre syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9. doi: 10.1002/mus.880141111.
- Results publication: PubMed 23584384Mirzakhani H, Williams JN, Mello J, Joseph S, Meyer MJ, Waak K, Schmidt U, Kelly E, Eikermann M. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013 Aug;119(2):389-97. doi: 10.1097/ALN.0b013e31829373fe.
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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.
Matthias Eikermann, MD, PhD principal investigator
MGH, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Swallowing Disorder and Aspiration, run by Massachusetts General Hospital at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 13 Oct 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Muscle Strength (time frame: Within 24 hours of fiberoptic endoscopic evaluation of swallow). 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 NCT01618240, which also lists 4 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 13 Oct 2014.