Dynamic Laryngotracheal Separation for Aspiration

NCT00580346 | Withdrawn

• 3 other identifiers: 01-01-02NIH DC-006703-01IDE G980179
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. Vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.

Conditions

Aspiration Pneumonia

Keywords

Aspiration pneumonia; Implanted laryngeal stimulator; Vocal cord closure; Modified barium swallow

Outcome Measures

Primary Outcomes (1)

• Videotaping vocal cords and modified barium swallows

  several months

Secondary Outcomes (2)

• Tolerance of implanted device

  immediate to several years

• comfort in swallowing

  one year

Study Arms (1)

2

EXPERIMENTAL

Device: Placement of laryngeal implant

Interventions

Placement of laryngeal implant DEVICE

Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both

Also known as: Modified Finetech Vocare Bladder stimulator, Huntington perineural electrodes

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aspiration pneumonia after neurological insults (e.g. stroke)
• Ability to understand the purpose of the research
• Appropriate hand motor control
• Inability to improve under standard treatments (speech-language pathologists)
• Acceptance of a tracheostomy

You may not qualify if:

• Lack of understanding the research
• Poor hand motor coordination
• Uncontrolled seizures
• Pregnancy
• Refusal to accept a tracheostomy

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Health System

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Broniatowski M, Grundfest-Broniatowski S, Tyler DJ, Scolieri P, Abbass F, Tucker HM, Brodsky S. Dynamic laryngotracheal closure for aspiration: a preliminary report. Laryngoscope. 2001 Nov;111(11 Pt 1):2032-40. doi: 10.1097/00005537-200111000-00031.

  PMID: 11801992 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Broniatowski, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 24, 2007
• Study Start: August 1, 2004
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

US (1)