Predictors of the Ability to Protect the Airway in Long-term Ventilated Patients

NCT01618240 | Completed Results DMC

• 1 other identifier: 2010P001919A
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

First part of a 2 part study with the same IRB protocol #, and labeled 'A'. Investigators hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the ability to protect the airway during swallowing in long-term ventilated subjects. More specifically, the investigators hypothesized that low muscle strength is associated with the inability to clear secretions from the peri-laryngeal area (valleculae and pyriform sinus residue scale (VPSR scale \[NRS: 0-4\] of \> 1) and entering the materials into airway (PAS scale \[1-8\]\> 1), which should predispose to endotracheal aspiration.

Conditions

Swallowing Disorder; Aspiration; Long Term Ventilation

Keywords

FEES; PAS; VPSR; MRC

Outcome Measures

Primary Outcomes (1)

• Muscle Strength

  We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients.

  Within 24 hours of fiberoptic endoscopic evaluation of swallow

Secondary Outcomes (1)

• Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration

  Within 3 month follow-up

Study Arms (1)

Long term ventilated subjects

Muscle Strength Measurement, ventilator

Other: Muscle Strength Measurement; Other: Ventilator

Interventions

Muscle Strength Measurement OTHER

MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement

Long term ventilated subjects

Ventilator OTHER

A mechanical ventilator is used to assist or replace spontaneous breathing.

Long term ventilated subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Long term ventilated and tracheostomized patients in the Respiratory Acute and Surgical Intensive Care Unit

You may qualify if:

• Patients admitted to the Respiratory Acute Care Unit and Surgical Intensive Care Unit, units with a mixed collection of long term ventilated patients in a major academic teaching hospital.
• Age over 18 years.
• Long-term ventilated patients (\>10 days) with tracheotomies

You may not qualify if:

• Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.
• Non-cooperative patient, CAM score positive for delirium.
• For women: pregnancy.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.

  PMID: 8721066 BACKGROUND

• Butler SG, Stuart A, Markley L, Rees C. Penetration and aspiration in healthy older adults as assessed during endoscopic evaluation of swallowing. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):190-8. doi: 10.1177/000348940911800306.

  PMID: 19374150 BACKGROUND

• Kleyweg RP, van der Meche FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barre syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9. doi: 10.1002/mus.880141111.

  PMID: 1745285 BACKGROUND

• Mirzakhani H, Williams JN, Mello J, Joseph S, Meyer MJ, Waak K, Schmidt U, Kelly E, Eikermann M. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013 Aug;119(2):389-97. doi: 10.1097/ALN.0b013e31829373fe.

  PMID: 23584384 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Ventilators, Mechanical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Hooman Mirzakhani
• Organization: Massachusetts General Hospital

hmirzakhani@partners.org

617-291-9779

Study Officials

• Matthias Eikermann, MD, PhD

  MGH, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 13, 2012
• Study Start: January 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 13, 2014
• Results First Posted: August 27, 2013

Record last verified: 2013-05

Locations

US (1)