Dysphagia Clinical Trial
Official title:
Aspiration in Acute Respiratory Failure Survivors
Verified date | June 2021 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 248 |
Est. completion date | November 30, 2020 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects will be eligible to participate in the study if they meet all of the following criteria: 1. Admission to a University of Colorado Hospital ICU 2. Mechanical ventilation support through an endotracheal tube for greater than 24 hours Exclusion Criteria: - Subjects will be ineligible to participate in the study if they meet any of the following criteria 1. Age less than 18 years 2. Contraindication to enteral nutrition administration 3. Diagnosis of an acute or pre-existing central nervous system disorder (excluding a seizure disorder) 4. Pre-existing dysphagia 5. Previous surgery of the head, neck, or esophagus 6. Previous cancer of the head or neck 7. The presence of a tracheostomy 8. The presence of nasal or pharyngeal trauma or bleeding 9. Clinical team believes one of the protocols would be harmful to an individual patient 10. Expected survival less than 3 months 11. Pregnancy 12. Imprisoned at the time of admission, anytime during the hospitalization, or anytime during the followup period 13. Inability to give informed consent and proxy unavailable. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital | Aurora | Colorado |
United States | Boston University Medical Center | Boston | Massachusetts |
United States | Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Boston University, National Heart, Lung, and Blood Institute (NHLBI), National Institute of Nursing Research (NINR) |
United States,
Altman KW, Yu GP, Schaefer SD. Consequence of dysphagia in the hospitalized patient: impact on prognosis and hospital resources. Arch Otolaryngol Head Neck Surg. 2010 Aug;136(8):784-9. doi: 10.1001/archoto.2010.129. — View Citation
American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. — View Citation
Aviv JE, Kaplan ST, Thomson JE, Spitzer J, Diamond B, Close LG. The safety of flexible endoscopic evaluation of swallowing with sensory testing (FEESST): an analysis of 500 consecutive evaluations. Dysphagia. 2000 Winter;15(1):39-44. — View Citation
Behrendt CE. Acute respiratory failure in the United States: incidence and 31-day survival. Chest. 2000 Oct;118(4):1100-5. — View Citation
Bousquet J, Knani J, Dhivert H, Richard A, Chicoye A, Ware JE Jr, Michel FB. Quality of life in asthma. I. Internal consistency and validity of the SF-36 questionnaire. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 1):371-5. — View Citation
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. — View Citation
Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. Review. — View Citation
Chastre J, Wolff M, Fagon JY, Chevret S, Thomas F, Wermert D, Clementi E, Gonzalez J, Jusserand D, Asfar P, Perrin D, Fieux F, Aubas S; PneumA Trial Group. Comparison of 8 vs 15 days of antibiotic therapy for ventilator-associated pneumonia in adults: a randomized trial. JAMA. 2003 Nov 19;290(19):2588-98. — View Citation
Chen AY, Frankowski R, Bishop-Leone J, Hebert T, Leyk S, Lewin J, Goepfert H. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M. D. Anderson dysphagia inventory. Arch Otolaryngol Head Neck Surg. 2001 Jul;127(7):870-6. — View Citation
Chrispin PS, Scotton H, Rogers J, Lloyd D, Ridley SA. Short Form 36 in the intensive care unit: assessment of acceptability, reliability and validity of the questionnaire. Anaesthesia. 1997 Jan;52(1):15-23. — View Citation
Cohen MA, Setzen M, Perlman PW, Ditkoff M, Mattucci KF, Guss J. The safety of flexible endoscopic evaluation of swallowing with sensory testing in an outpatient otolaryngology setting. Laryngoscope. 2003 Jan;113(1):21-4. — View Citation
Ekberg O, Hamdy S, Woisard V, Wuttge-Hannig A, Ortega P. Social and psychological burden of dysphagia: its impact on diagnosis and treatment. Dysphagia. 2002 Spring;17(2):139-46. — View Citation
Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. — View Citation
Esteban A, Anzueto A, Frutos F, Alía I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguía C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. — View Citation
Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM. CDC definitions for nosocomial infections, 1988. Am J Infect Control. 1988 Jun;16(3):128-40. Erratum in: Am J Infect Control 1988 Aug;16(4):177. — View Citation
Goldsmith T. Evaluation and treatment of swallowing disorders following endotracheal intubation and tracheostomy. Int Anesthesiol Clin. 2000 Summer;38(3):219-42. Review. — View Citation
Guidelines and procedures for monitoring VAP. 2011. United States Centers for Disease Control and Prevention (CDC) and National Healthcare Safety Network (NHSN). 22 December 2011. http://www.cdc.gov/nhsn/psc_da.html. 2011; 1-12.
Hiss SG, Postma GN. Fiberoptic endoscopic evaluation of swallowing. Laryngoscope. 2003 Aug;113(8):1386-93. Review. — View Citation
Hospital-acquired pneumonia in adults: diagnosis, assessment of severity, initial antimicrobial therapy, and preventive strategies. A consensus statement, American Thoracic Society, November 1995. Am J Respir Crit Care Med. 1996 May;153(5):1711-25. Review. — View Citation
Langmore SE, Pelletier C, Nelson. Results of FEES survey on safety of endoscopy for swallowing assessment. Presented at Fourth Annual Meeting of the Dysphagia Research Society, McLean, VA, October 28, 1995.
Leder SB, Suiter DM, Warner HL, Acton LM, Siegel MD. Safe initiation of oral diets in hospitalized patients based on passing a 3-ounce (90 cc) water swallow challenge protocol. QJM. 2012 Mar;105(3):257-63. doi: 10.1093/qjmed/hcr193. Epub 2011 Oct 17. — View Citation
Lim SH, Lieu PK, Phua SY, Seshadri R, Venketasubramanian N, Lee SH, Choo PW. Accuracy of bedside clinical methods compared with fiberoptic endoscopic examination of swallowing (FEES) in determining the risk of aspiration in acute stroke patients. Dysphagia. 2001 Winter;16(1):1-6. — View Citation
Macht M, Wimbish T, Clark BJ, Benson AB, Burnham EL, Williams A, Moss M. Postextubation dysphagia is persistent and associated with poor outcomes in survivors of critical illness. Crit Care. 2011;15(5):R231. doi: 10.1186/cc10472. Epub 2011 Sep 29. — View Citation
Marik PE. Aspiration pneumonitis and aspiration pneumonia. N Engl J Med. 2001 Mar 1;344(9):665-71. Review. — View Citation
Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. Epub 2005 Nov 3. Review. — View Citation
Nacci A, Ursino F, La Vela R, Matteucci F, Mallardi V, Fattori B. Fiberoptic endoscopic evaluation of swallowing (FEES): proposal for informed consent. Acta Otorhinolaryngol Ital. 2008 Aug;28(4):206-11. — View Citation
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network, Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. Epub 2006 May 21. — View Citation
O'Neil KH, Purdy M, Falk J, Gallo L. The Dysphagia Outcome and Severity Scale. Dysphagia. 1999 Summer;14(3):139-45. — View Citation
Report on the ASHA Speech-Language Pathology Health Care Survey American Speech-Language-Hearing Association. 2011 SLP health care survey summary report: Number and type ofresponses. Available from: http://www.asha.org/uploadedFiles/HC11-Summary-Report.pdf. 2011; 1-49.
Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. — View Citation
Skoretz 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. Review. — View Citation
Suiter DM, Leder SB. Clinical utility of the 3-ounce water swallow test. Dysphagia. 2008 Sep;23(3):244-50. Epub 2007 Dec 4. — View Citation
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. — View Citation
* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Experiencing Aspiration | Aim: To develop a BSE-based non-invasive clinical prediction rule (CPR) that will accurately and efficiently diagnose aspiration in ARF survivors. Aspiration (PAS score of =6) on the FEES with any of the five feedings. This outcome measure will report the percentage of participants experiencing silent and non-silent aspiration, as visualized on the FEES. The FEES is a flexible fiberoptic camera that allows the investigators to visualize the patient swallowing each of the 5 different consistencies of food. | from extubation Day 1 through hospital discharge, expected to be within 28 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03711474 -
Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal)
|
Phase 4 | |
Enrolling by invitation |
NCT04074356 -
Non-invasive Markers of Esophageal Function in Adults
|
N/A | |
Suspended |
NCT04349462 -
Post Critical Illness Dysphagia in the Intensive Care Unit
|
N/A | |
Not yet recruiting |
NCT05982977 -
Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke
|
N/A | |
Recruiting |
NCT03605381 -
MORbidity PRevalence Estimate In StrokE
|
||
Active, not recruiting |
NCT03455608 -
PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
|
N/A | |
Active, not recruiting |
NCT03604822 -
Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS
|
N/A | |
Recruiting |
NCT03682081 -
Interventions for Patients With Alzheimer's Disease and Dysphagia
|
N/A | |
Completed |
NCT05700838 -
Refining Cough Skill Training in Parkinson's Disease and Dysphagia
|
Phase 1 | |
Not yet recruiting |
NCT04064333 -
Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
|
N/A | |
Completed |
NCT02927691 -
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
|
Phase 2 | |
Not yet recruiting |
NCT02724761 -
Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion
|
N/A | |
Completed |
NCT01919112 -
Fostering Eating After Stroke With Transcranial Direct Current Stimulation
|
N/A | |
Completed |
NCT01370083 -
Tongue Pressure Profile Training for Dysphagia Post Stroke
|
Phase 2 | |
Completed |
NCT01723358 -
Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia
|
Phase 2 | |
Withdrawn |
NCT01200147 -
Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation
|
N/A | |
Completed |
NCT00570557 -
Development of a Web-Based Course to Maintain Skills in Nurses Trained to Screen for Dysphagia
|
N/A | |
Recruiting |
NCT00166751 -
Sonographic Assessment of Laryngeal Elevation
|
N/A | |
Completed |
NCT00717028 -
Functional Endoscopic Evaluation of Swallowing
|
N/A | |
Completed |
NCT01476241 -
Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist
|
N/A |