DysphagiaNCT05108896
Aspiration in Acute Respiratory Failure Survivors 2
A study testing 3-Screenings Protocol, FEES and Tracheal Ultrasound in people with Dysphagia and Aspiration, run by University of Colorado, Denver at 5 sites in United States.
Trial summary
The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Aspiration
- What is being tested?
- 3-Screenings Protocol, FEES and Tracheal Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 855 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Dec 2021to 15 Dec 2025
- 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
- Admission to an ICU.
- Mechanical ventilation with an endotracheal tube for greater than 48 hours.
Who cannot join
- Likely persistent contraindications to enteral/oral nutrition administration.
- Pre-existing history of dysphagia or aspiration.
- Pre-existing or acute primary central or peripheral neuromuscular disorder.
- Presence of a chronic tracheostomy (present prior to ICU admission).
- Pre-existing head and neck cancer or surgery.
- Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.
Show all 10Show fewer
- Delirium for more than 96 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU).
- Extubated for greater than 96 hours.
- Inability to obtain informed consent from patient or an appropriate surrogate.
- Age < 18 years.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Anna Matheson, RN, BSN, 303-724-6377, anna.matheson@cuanschutz.edu
Jeffrey McKeehan, RN, MSN, 3037246080, Jeffrey.McKeehan@cuanschutz.edu
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Nicholas Hill, MD, nicholas.hill@tuftsmedicine.org
Nicholas Hill, MD
- Recruiting
Boston University
Boston, Massachusetts, 02118
Gintas Krisciunas, MPH, MS, Gintas.Krisciunas@bmc.org
Gintas Krisciunas, MPH, MS
- Recruiting
Yale University
New Haven, Connecticut, 06519
Jonathan Siner, MD, Jonathan.Siner@yale.edu
Jonathan Siner, MD
- Recruiting
Stanford Univerity
Stanford, California, 94305
Joseph Levitt, MD, MS, JLevitt@stanford.edu
Joseph Levitt, MD, MS
About this study
Official title: Aspiration in Acute Respiratory Failure Survivors
The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.
Read the detailed description
The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. Patients are asked to be in this study because they had problems breathing on their own and therefore needed the help of a machine called a ventilator. In order for this ventilator to push air into the lungs, patients need a tube placed in the throat called an endotracheal tube. The process of placing this endotracheal tube was called intubation. The tube has now been removed, which is a process called extubation. Sometimes, people who have had endotracheal tubes can have difficulty swallowing food and liquids for a period of time. This disease is called post-extubation dysphagia (PED). PED is a serious condition and may result in food or liquid going from the mouth into the lungs. This could cause further lung problems. Given this risk, doctors sometimes suggest that patients with PED either avoid eating or drinking, or get a feeding tube. Currently, nobody knows how often patients develop PED, why they develop it, or the best method to detect it. Standard care involves clinicians making educated guesses. This study looks to determine if watching the patient swallow, both with and without a small camera, is an accurate method for detecting PED.
- Conditions
- Dysphagia, Aspiration
- Being tested
- 3-Screenings Protocol, FEES, Tracheal Ultrasound
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Screenings ProtocolDiagnostic test
Also called Modified bedside swallow exam (BSE), Three Screening Tests
The 3-Screenings Protocol is a modified bedside swallow exam (BSE) consisting of a study developed five-item decision tree algorithm including voice quality assessment and a 2-ounce water consistency assessment, the Yale Swallow Test, with a scored 3-ounce Water Swallow Test (3-WST), and the Toronto Bedside Swallowing Screening Test (TOR-BSST).
FEESDiagnostic test
Also called Fiberoptic Endoscopic Evaluation of Swallowing
A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.
Tracheal UltrasoundDiagnostic test
Ultrasound imaging of the trachea, measuring tracheal diameter and endotracheal tube (ETT) size ratio within 72 hours prior to extubation
| Study group | Role | What they receive |
|---|---|---|
| Aspiration in Acute Respiratory Failure Survivors | Other | All participants will receive a tracheal ultrasound within 72 hours prior to extubation, collection of demographic and hospital clinical information, administration of 3 screening tests (study defined algorithm test, 3-ounce water swallow test, TOR-BSST) addressing swallowing function within 24 hours post-extubation, and a fiberoptic endoscopic examination of swallowing (FEES) exam. Receives: Diagnostic Test: 3-Screenings Protocol; Diagnostic Test: FEES; Diagnostic Test: Tracheal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies
Aspiration (PAS score of ≥6) on the FEES with any of the feeding consistencies. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of ≥6 on FEES, patients will be stratified by aspiration on any of the five consistencies.
Measured: from extubation day 1 through hospital discharge, expected to be within 28 days
Secondary outcomes (5)
Percentage of participants experiencing non-silent aspiration
We will stratify patients who aspirate into non-silent (PA = 6- 7) and silent (PAS=8) aspiration, and also determine maximum PAS scores across bolus and consistency types. Aspiration (PAS score of ≥6) on the FEES with any of the feeding consistencies. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of ≥6 on FEES, patients will be stratified by aspiration on any of the five consistencies. We will also determine the maximum PAS scores across bolus and consistency types.
Measured: from extubation day 1 through hospital discharge, expected to be within 28 days
Percentage of participants experiencing silent aspiration
We will stratify patients who aspirate into non-silent (PA = 6- 7) and silent (PAS=8) aspiration, and also determine maximum PAS scores across bolus and consistency types. Aspiration (PAS score of ≥6) on the FEES with any of the feeding consistencies. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of ≥6 on FEES, patients will be stratified by aspiration on any of the five consistencies. We will also determine the maximum PAS scores across bolus and consistency types.
Measured: from extubation day 1 through hospital discharge, expected to be within 28 days
Percentage of participants experiencing post-extubation clinical laryngeal edema
We will define laryngeal edema as upper-airway obstruction within 24 hours after extubation. Minor laryngeal edema will be defined as stridor associated with a respiratory distress defined as a prolonged inspiratory phase and the presence of edema on FEES examination. Major laryngeal edema will defined as severe respiratory distress needing tracheal reintubation secondary to upper-airway obstruction that was visualized during the FEES examination
Measured: Within 24 hours after extubation
Duration of mechanical ventilation
We will also collect the overall length of mechanical ventilation in days
Measured: from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average
Duration required for liberation from mechanical ventilation
We will also collect the overall length of the liberation process from mechanical ventilation in days
Measured: from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start15 Dec 2021
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (112)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-center prospective single cohort study
- Masking
- None (open label)
- Enrolment
- 855 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Marc Moss, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108896
- Sponsor's protocol ID
- 21-3873
- Other IDs
- R01NR019989
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2021
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kempker JA, Abril MK, Chen Y, Kramer MR, Waller LA, Martin GS. The Epidemiology of Respiratory Failure in the United States 2002-2017: A Serial Cross-Sectional Study. Crit Care Explor. 2020 Jun 10;2(6):e0128. doi: 10.1097/CCE.0000000000000128. eCollection 2020 Jun.
PubMed 32695994Wunsch H, Linde-Zwirble WT, Angus DC, Hartman ME, Milbrandt EB, Kahn JM. The epidemiology of mechanical ventilation use in the United States. Crit Care Med. 2010 Oct;38(10):1947-53. doi: 10.1097/CCM.0b013e3181ef4460.
PubMed 20639743Barker J, Martino R, Reichardt B, Hickey EJ, Ralph-Edwards A. Incidence and impact of dysphagia in patients receiving prolonged endotracheal intubation after cardiac surgery. Can J Surg. 2009 Apr;52(2):119-24.
PubMed 19399206El Solh A, Okada M, Bhat A, Pietrantoni C. Swallowing disorders post orotracheal intubation in the elderly. Intensive Care Med. 2003 Sep;29(9):1451-5. doi: 10.1007/s00134-003-1870-4. Epub 2003 Aug 2.
PubMed 12904855Macht M, White SD, Moss M. Swallowing dysfunction after critical illness. Chest. 2014 Dec;146(6):1681-1689. doi: 10.1378/chest.14-1133.
PubMed 25451355Macht M, Wimbish T, Bodine C, Moss M. ICU-acquired swallowing disorders. Crit Care Med. 2013 Oct;41(10):2396-405. doi: 10.1097/CCM.0b013e31829caf33.
PubMed 23939361Skoretz SA, Flowers HL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010 Mar;137(3):665-73. doi: 10.1378/chest.09-1823.
PubMed 20202948Moss M, White SD, Warner H, Dvorkin D, Fink D, Gomez-Taborda S, Higgins C, Krisciunas GP, Levitt JE, McKeehan J, McNally E, Rubio A, Scheel R, Siner JM, Vojnik R, Langmore SE. Development of an Accurate Bedside Swallowing Evaluation Decision Tree Algorithm for Detecting Aspiration in Acute Respiratory Failure Survivors. Chest. 2020 Nov;158(5):1923-1933. doi: 10.1016/j.chest.2020.07.051. Epub 2020 Jul 25.
PubMed 32721404Borders JC, Fink D, Levitt JE, McKeehan J, McNally E, Rubio A, Scheel R, Siner JM, Taborda SG, Vojnik R, Warner H, White SD, Langmore SE, Moss M, Krisciunas GP. Relationship Between Laryngeal Sensation, Length of Intubation, and Aspiration in Patients with Acute Respiratory Failure. Dysphagia. 2019 Aug;34(4):521-528. doi: 10.1007/s00455-019-09980-1. Epub 2019 Jan 29.
PubMed 30694412Krisciunas GP, Langmore SE, Gomez-Taborda S, Fink D, Levitt JE, McKeehan J, McNally E, Scheel R, Rubio AC, Siner JM, Vojnik R, Warner H, White SD, Moss M. The Association Between Endotracheal Tube Size and Aspiration (During Flexible Endoscopic Evaluation of Swallowing) in Acute Respiratory Failure Survivors. Crit Care Med. 2020 Nov;48(11):1604-1611. doi: 10.1097/CCM.0000000000004554.
PubMed 32804785DePippo KL, Holas MA, Reding MJ. Validation of the 3-oz water swallow test for aspiration following stroke. Arch Neurol. 1992 Dec;49(12):1259-61. doi: 10.1001/archneur.1992.00530360057018.
PubMed 1449405Martino R, Silver F, Teasell R, Bayley M, Nicholson G, Streiner DL, Diamant NE. The Toronto Bedside Swallowing Screening Test (TOR-BSST): development and validation of a dysphagia screening tool for patients with stroke. Stroke. 2009 Feb;40(2):555-61. doi: 10.1161/STROKEAHA.107.510370. Epub 2008 Dec 12.
PubMed 19074483Suiter DM, Leder SB. Clinical utility of the 3-ounce water swallow test. Dysphagia. 2008 Sep;23(3):244-50. doi: 10.1007/s00455-007-9127-y. Epub 2007 Dec 4.
PubMed 18058175Suiter DM, Sloggy J, Leder SB. Validation of the Yale Swallow Protocol: a prospective double-blinded videofluoroscopic study. Dysphagia. 2014 Apr;29(2):199-203. doi: 10.1007/s00455-013-9488-3. Epub 2013 Sep 12.
PubMed 24026519Langmore SE. Role of flexible laryngoscopy for evaluating aspiration. Ann Otol Rhinol Laryngol. 1998 May;107(5 Pt 1):446. doi: 10.1177/000348949810700516. No abstract available.
PubMed 9596227
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspiration in Acute Respiratory Failure Survivors
- ClinicalTrials.gov ID
- NCT05108896
- Acronym / sponsor ID
- 21-3873
- Conditions
- Dysphagia, Aspiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 855 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 5 Nov 2021 (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.
The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.
Detailed description
The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. Patients are asked to be in this study because they had problems breathing on their own and therefore needed the help of a machine called a ventilator. In order for this ventilator to push air into the lungs, patients need a tube placed in the throat called an endotracheal tube. The process of placing this endotracheal tube was called intubation. The tube has now been removed, which is a process called extubation. Sometimes, people who have had endotracheal tubes can have difficulty swallowing food and liquids for a period of time. This disease is called post-extubation dysphagia (PED). PED is a serious condition and may result in food or liquid going from the mouth into the lungs. This could cause further lung problems. Given this risk, doctors sometimes suggest that patients with PED either avoid eating or drinking, or get a feeding tube. Currently, nobody knows how often patients develop PED, why they develop it, or the best method to detect it. Standard care involves clinicians making educated guesses. This study looks to determine if watching the patient swallow, both with and without a small camera, is an accurate method for detecting PED.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-center prospective single cohort study
| Arm | Type | Receives |
|---|---|---|
| Aspiration in Acute Respiratory Failure Survivors | Other | Diagnostic Test: 3-Screenings Protocol, Diagnostic Test: FEES, Diagnostic Test: Tracheal UltrasoundAll participants will receive a tracheal ultrasound within 72 hours prior to extubation, collection of demographic and hospital clinical information, administration of 3 screening tests (study defined algorithm test, 3-ounce water swallow test, TOR-BSST) addressing swallowing function within 24 hours post-extubation, and a fiberoptic endoscopic examination of swallowing (FEES) exam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admission to an ICU.
- Mechanical ventilation with an endotracheal tube for greater than 48 hours.
Key exclusion criteria (10 listed)
- Likely persistent contraindications to enteral/oral nutrition administration.
- Pre-existing history of dysphagia or aspiration.
- Pre-existing or acute primary central or peripheral neuromuscular disorder.
- Presence of a chronic tracheostomy (present prior to ICU admission).
- Pre-existing head and neck cancer or surgery.
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 |
|---|---|---|
| 3-Screenings ProtocolAlso: Modified bedside swallow exam (BSE), Three Screening TestsThe 3-Screenings Protocol is a modified bedside swallow exam (BSE) consisting of a study developed five-item decision tree algorithm including voice quality assessment and a 2-ounce water consistency assessment, the Yale Swallow Test, with a scored 3-ounce Water Swallow Test (3-WST), and the Toronto Bedside Swallowing Screening Test (TOR-BSST). | Diagnostic test | Aspiration in Acute Respiratory Failure Survivors |
| FEESAlso: Fiberoptic Endoscopic Evaluation of SwallowingA thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed. | Diagnostic test | Aspiration in Acute Respiratory Failure Survivors |
| Tracheal UltrasoundUltrasound imaging of the trachea, measuring tracheal diameter and endotracheal tube (ETT) size ratio within 72 hours prior to extubation | Diagnostic test | Aspiration in Acute Respiratory Failure Survivors |
Primary outcome
Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies
Time frame: from extubation day 1 through hospital discharge, expected to be within 28 days
Aspiration (PAS score of ≥6) on the FEES with any of the feeding consistencies. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of ≥6 on FEES, patients will be stratified by aspiration on any of the five consistencies.
5 secondary outcomes
Percentage of participants experiencing non-silent aspiration
Time frame: from extubation day 1 through hospital discharge, expected to be within 28 days
Percentage of participants experiencing silent aspiration
Time frame: from extubation day 1 through hospital discharge, expected to be within 28 days
Percentage of participants experiencing post-extubation clinical laryngeal edema
Time frame: Within 24 hours after extubation
Duration of mechanical ventilation
Time frame: from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average
Duration required for liberation from mechanical ventilation
Time frame: from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 32695994Kempker JA, Abril MK, Chen Y, Kramer MR, Waller LA, Martin GS. The Epidemiology of Respiratory Failure in the United States 2002-2017: A Serial Cross-Sectional Study. Crit Care Explor. 2020 Jun 10;2(6):e0128. doi: 10.1097/CCE.0000000000000128. eCollection 2020 Jun.
- Background: PubMed 20639743Wunsch H, Linde-Zwirble WT, Angus DC, Hartman ME, Milbrandt EB, Kahn JM. The epidemiology of mechanical ventilation use in the United States. Crit Care Med. 2010 Oct;38(10):1947-53. doi: 10.1097/CCM.0b013e3181ef4460.
- Background: PubMed 19399206Barker J, Martino R, Reichardt B, Hickey EJ, Ralph-Edwards A. Incidence and impact of dysphagia in patients receiving prolonged endotracheal intubation after cardiac surgery. Can J Surg. 2009 Apr;52(2):119-24.
- Background: PubMed 12904855El Solh A, Okada M, Bhat A, Pietrantoni C. Swallowing disorders post orotracheal intubation in the elderly. Intensive Care Med. 2003 Sep;29(9):1451-5. doi: 10.1007/s00134-003-1870-4. Epub 2003 Aug 2.
- Background: PubMed 25451355Macht M, White SD, Moss M. Swallowing dysfunction after critical illness. Chest. 2014 Dec;146(6):1681-1689. doi: 10.1378/chest.14-1133.
- Background: PubMed 23939361Macht M, Wimbish T, Bodine C, Moss M. ICU-acquired swallowing disorders. Crit Care Med. 2013 Oct;41(10):2396-405. doi: 10.1097/CCM.0b013e31829caf33.
- Background: PubMed 20202948Skoretz SA, Flowers HL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010 Mar;137(3):665-73. doi: 10.1378/chest.09-1823.
- Background: PubMed 32721404Moss M, White SD, Warner H, Dvorkin D, Fink D, Gomez-Taborda S, Higgins C, Krisciunas GP, Levitt JE, McKeehan J, McNally E, Rubio A, Scheel R, Siner JM, Vojnik R, Langmore SE. Development of an Accurate Bedside Swallowing Evaluation Decision Tree Algorithm for Detecting Aspiration in Acute Respiratory Failure Survivors. Chest. 2020 Nov;158(5):1923-1933. doi: 10.1016/j.chest.2020.07.051. Epub 2020 Jul 25.
- Background: PubMed 30694412Borders JC, Fink D, Levitt JE, McKeehan J, McNally E, Rubio A, Scheel R, Siner JM, Taborda SG, Vojnik R, Warner H, White SD, Langmore SE, Moss M, Krisciunas GP. Relationship Between Laryngeal Sensation, Length of Intubation, and Aspiration in Patients with Acute Respiratory Failure. Dysphagia. 2019 Aug;34(4):521-528. doi: 10.1007/s00455-019-09980-1. Epub 2019 Jan 29.
- Background: PubMed 32804785Krisciunas GP, Langmore SE, Gomez-Taborda S, Fink D, Levitt JE, McKeehan J, McNally E, Scheel R, Rubio AC, Siner JM, Vojnik R, Warner H, White SD, Moss M. The Association Between Endotracheal Tube Size and Aspiration (During Flexible Endoscopic Evaluation of Swallowing) in Acute Respiratory Failure Survivors. Crit Care Med. 2020 Nov;48(11):1604-1611. doi: 10.1097/CCM.0000000000004554.
- Background: PubMed 1449405DePippo KL, Holas MA, Reding MJ. Validation of the 3-oz water swallow test for aspiration following stroke. Arch Neurol. 1992 Dec;49(12):1259-61. doi: 10.1001/archneur.1992.00530360057018.
- Background: PubMed 19074483Martino R, Silver F, Teasell R, Bayley M, Nicholson G, Streiner DL, Diamant NE. The Toronto Bedside Swallowing Screening Test (TOR-BSST): development and validation of a dysphagia screening tool for patients with stroke. Stroke. 2009 Feb;40(2):555-61. doi: 10.1161/STROKEAHA.107.510370. Epub 2008 Dec 12.
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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.
Marc Moss, MD principal investigator
University of Colorado, Denver
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-Screenings Protocol, FEES and Tracheal Ultrasound in people with Dysphagia and Aspiration, run by University of Colorado, Denver at 5 sites 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 2 inclusion and 10 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeff McKeehan, RN,MSN (3037246080, jeffrey.mckeehan@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies (time frame: from extubation day 1 through hospital discharge, expected to be within 28 days). 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 NCT05108896, which also lists 112 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 8 Oct 2024.