Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
58 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-07-31
Study Completion Date
2022-08-31
Brief Summary
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An early intervention for swallowing disorders (i.e., dysphagia) during endotracheal intubation may improve patient outcomes. The investigators propose treatment sessions targeting sensorimotor integration, strength, and range of motion during oral endotracheal intubation with mechanical ventilation to reduce or prevent dysphagia and aspiration (food or liquids entering the airway), establish a solid foundation in understanding reasons for swallowing impairment after extubation from mechanical ventilation and learn new methods to reduce or prevent these problems.
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Detailed Description
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The overall goals of this study are to evaluate patients with acute respiratory failure from the time they are orally intubated in the ICU to: 1) investigate tongue weakness and other pathophysiological aspects of dysphagia, and 2) evaluate, in a Phase II clinical trial, a novel, multimodal, sensorimotor intervention conducted during intubation to reduce or prevent dysphagia after extubation. Patients who are expected to be intubated with mechanical ventilation for \>96 hours will be consecutively enrolled shortly after intubation. Laryngeal function, tongue strength, swallowing pathophysiology, and breathing-swallowing coordination will be evaluated with valid and reliable standardized measures. While orally intubated, patients in the treatment group will receive a novel, early, sensorimotor intervention for 60-minutes daily, 5 times per week, targeting improved swallowing physiology and kinematics to reduce aspiration and dysphagia. These daily sessions will continue until the completion of a modified barium swallow study conducted within approximately 2 days after extubation, and thereafter standard clinical care will resume. Patients in the control group will receive standard clinical care during intubation and throughout their hospital stay. All patients will be followed to hospital discharge to determine the pathophysiological and clinical impact of the proposed intervention. Knowledge from this study will provide important data for this novel intervention and provide a critical foundation for understanding the physiological mechanisms of dysphagia and aspiration after intubation in patients with acute respiratory failure. With success, this investigation will help shift clinical practice patterns to consider early intervention with the goal of reducing the frequency and severity of swallowing impairment leading to aspiration and additional medical complications.
Conditions
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Deglutition Disorders
Mechanical Ventilation Complication
Complication of Ventilation Therapy
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Exercise and sensory stimulation
60-minute sessions with sensory electrical stimulation (SES) applied 5 days per week with oromotor exercises completed when patient is able to participate
Group Type
EXPERIMENTAL
Exercise and sensory stimulation
Intervention Type
BEHAVIORAL
60-minute sessions with sensory electrical stimulation (SES) applied 5 days per week with oromotor exercises completed when patient is able to participate
Interventions
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Exercise and sensory stimulation
60-minute sessions with sensory electrical stimulation (SES) applied 5 days per week with oromotor exercises completed when patient is able to participate
Intervention Type
BEHAVIORAL
Other Intervention Names
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VitalStim (Chattanooga Group; Hixson, TN)
Eligibility Criteria
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Inclusion Criteria
* ≥18 years old
* Required mechanical ventilation via an oral endotracheal tube
* Required mechanical ventilation via an oral endotracheal tube
Exclusion Criteria
* Unable to understand or speak English due to a language barrier
* Unable to understand or speak English due to a cognitive impairment
* Barium sulfate allergy
* Pregnancy
* Presence of any cardiac pacing device (including temporary epicardial pacing) without an underlying cardiac rhythm as confirmed by treating physician or diaphragmatic pacer
* Nasal endotracheal intubation during the present admission
* Patient is not expected to require ≥48 hours of intubation
* Pre-existing dysphagia/aspiration, voice or cognitive disorder
* Reflux with history of known or suspected aspiration
* Presence of a central nervous system, neuromuscular or connective tissue disease (e.g., stroke, Guillain-Barre, scleroderma)
* Active seizure disorder
* Pain disorder of the jaw muscles or mandibular joint
* Ever tracheotomy or prior endotracheal intubation other than for surgery (≤ 1 year)
* Head and/or neck disease (e.g., oropharyngeal cancer)
* Head and/or neck surgery other than tonsillectomy
* Known or suspected anatomical abnormalities or pre-intubation trauma of the oral cavity, pharynx, larynx, or esophagus
* Known or suspected sleep apnea (treated or untreated)
* Prior major thoracic surgery (e.g., sternotomy, thoracotomy)
* Unplanned (e.g., self- or accidental) extubation or re-intubation before consent
* Weight exceeds capacity of the radiology equipment
* Expected tracheostomy tube placement while in hospital
* Moribund (\>90% probability of mortality in hospital), based on ICU team's assessment
* Unable to understand or speak English due to a cognitive impairment
* Barium sulfate allergy
* Pregnancy
* Presence of any cardiac pacing device (including temporary epicardial pacing) without an underlying cardiac rhythm as confirmed by treating physician or diaphragmatic pacer
* Nasal endotracheal intubation during the present admission
* Patient is not expected to require ≥48 hours of intubation
* Pre-existing dysphagia/aspiration, voice or cognitive disorder
* Reflux with history of known or suspected aspiration
* Presence of a central nervous system, neuromuscular or connective tissue disease (e.g., stroke, Guillain-Barre, scleroderma)
* Active seizure disorder
* Pain disorder of the jaw muscles or mandibular joint
* Ever tracheotomy or prior endotracheal intubation other than for surgery (≤ 1 year)
* Head and/or neck disease (e.g., oropharyngeal cancer)
* Head and/or neck surgery other than tonsillectomy
* Known or suspected anatomical abnormalities or pre-intubation trauma of the oral cavity, pharynx, larynx, or esophagus
* Known or suspected sleep apnea (treated or untreated)
* Prior major thoracic surgery (e.g., sternotomy, thoracotomy)
* Unplanned (e.g., self- or accidental) extubation or re-intubation before consent
* Weight exceeds capacity of the radiology equipment
* Expected tracheostomy tube placement while in hospital
* Moribund (\>90% probability of mortality in hospital), based on ICU team's assessment
Minimum Eligible Age
18 Years
Maximum Eligible Age
100 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Sponsor Role
collaborator
Johns Hopkins University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Dale M Needham, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Site Status
Countries
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United States
References
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Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
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Hussain SN, Mofarrahi M, Sigala I, Kim HC, Vassilakopoulos T, Maltais F, Bellenis I, Chaturvedi R, Gottfried SB, Metrakos P, Danialou G, Matecki S, Jaber S, Petrof BJ, Goldberg P. Mechanical ventilation-induced diaphragm disuse in humans triggers autophagy. Am J Respir Crit Care Med. 2010 Dec 1;182(11):1377-86. doi: 10.1164/rccm.201002-0234OC. Epub 2010 Jul 16.
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Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.
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BACKGROUND
Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
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Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
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Needham DM. Mobilizing patients in the intensive care unit: improving neuromuscular weakness and physical function. JAMA. 2008 Oct 8;300(14):1685-90. doi: 10.1001/jama.300.14.1685.
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Needham DM, Korupolu R, Zanni JM, Pradhan P, Colantuoni E, Palmer JB, Brower RG, Fan E. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. doi: 10.1016/j.apmr.2010.01.002.
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Orlikowski D, Terzi N, Blumen M, Sharshar T, Raphael JC, Annane D, Lofaso F. Tongue weakness is associated with respiratory failure in patients with severe Guillain-Barre syndrome. Acta Neurol Scand. 2009 Jun;119(6):364-70. doi: 10.1111/j.1600-0404.2008.01107.x. Epub 2008 Oct 22.
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BACKGROUND
Robbins J, Gangnon RE, Theis SM, Kays SA, Hewitt AL, Hind JA. The effects of lingual exercise on swallowing in older adults. J Am Geriatr Soc. 2005 Sep;53(9):1483-9. doi: 10.1111/j.1532-5415.2005.53467.x.
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Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, Taylor AJ. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehabil. 2007 Feb;88(2):150-8. doi: 10.1016/j.apmr.2006.11.002.
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Sharshar T, Ross ET, Hopkinson NS, Porcher R, Nickol AH, Jonville S, Dayer MJ, Hart N, Moxham J, Lofaso F, Polkey MI. Depression of diaphragm motor cortex excitability during mechanical ventilation. J Appl Physiol (1985). 2004 Jul;97(1):3-10. doi: 10.1152/japplphysiol.01099.2003. Epub 2004 Mar 12.
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Yeates EM, Molfenter SM, Steele CM. Improvements in tongue strength and pressure-generation precision following a tongue-pressure training protocol in older individuals with dysphagia: three case reports. Clin Interv Aging. 2008;3(4):735-47. doi: 10.2147/cia.s3825.
Reference Type
BACKGROUND
Other Identifiers
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IRB00029289
Identifier Type: -
Identifier Source: org_study_id
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