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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02363686
Other study ID # 12-0184
Secondary ID 5K24HL0892231R21
Status Completed
Phase N/A
First received
Last updated
Start date February 2012
Est. completion date November 30, 2020

Study information

Verified date June 2021
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
FEES
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.
BSE
Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test.

Locations

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

Sponsors (4)

Lead Sponsor Collaborator
University of Colorado, Denver Boston University, National Heart, Lung, and Blood Institute (NHLBI), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (33)

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 allClick here to view all references

Outcome

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
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