PReventing the EffectS of Intubation on DEglutition

NCT02442102 | Terminated

• 2 other identifiers: IRB000292891K23DC013569-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deglutition Disorders; Mechanical Ventilation Complication; Complication of Ventilation Therapy

Keywords

deglutition disorders; therapeutics; rehabilitation; outcome assessment; intubation; critical care; larynx; voice

Outcome Measures

Primary Outcomes (1)

• Number of participants aspirating during fiberoptic endoscopic swallow study

  participants will be evaluated an expected average of 48 hours after extubation

Study Arms (1)

Exercise and sensory stimulation

EXPERIMENTAL

60-minute sessions with sensory electrical stimulation (SES) applied 5 days per week with oromotor exercises completed when patient is able to participate

Behavioral: Exercise and sensory stimulation

Interventions

Exercise and sensory stimulation BEHAVIORAL

60-minute sessions with sensory electrical stimulation (SES) applied 5 days per week with oromotor exercises completed when patient is able to participate

Also known as: VitalStim (Chattanooga Group; Hixson, TN)

Exercise and sensory stimulation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Required mechanical ventilation via an oral endotracheal tube

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

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MeSH Terms

Conditions

Deglutition Disorders; Laryngeal Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dale M Needham, MD PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 13, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 10, 2023

Record last verified: 2022-12

Locations

US (1)