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

Swallowing Disorder Clinical Trial

Official title:

Determining Predictors of Adequate Upper Airway Function in Long-term Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618240
• Other study ID #: 2010P001919A
• Status: Completed
• Phase: N/A
• First received: June 6, 2012
• Last updated: October 2, 2014
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Age over 18 years.

3. Long-term ventilated patients (>10 days) with tracheotomies

Exclusion Criteria:

1. Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.

2. Non-cooperative patient, CAM score positive for delirium.

3. For women: pregnancy.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aspiration
• Deglutition Disorders
• Long Term Ventilation
• Swallowing Disorder

Intervention

Other:
• Muscle Strength Measurement
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
• Ventilator
A mechanical ventilator is used to assist or replace spontaneous breathing.

Locations

Country	Name	City	State
United States	Massachusetts general Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Kleyweg RP, van der Meché FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barré syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9. — View Citation

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: 10.1 — View Citation

Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration		Within 3 month follow-up	Yes