Clinical trial NCT01618240: Predictors of the Ability to Protect the Airway in Long-term Ventilated Patients
Official title: Determining Predictors of Adequate Upper Airway Function in Long-term Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Swallowing Disorder
Aspiration
Long Term Ventilation
Keywords: FEES
PAS
VPSR
MRC
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long term ventilated and tracheostomized patients in the Respiratory Acute and Surgical Intensive Care Unit

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Muscle Strength
timeFrame: Within 24 hours of fiberoptic endoscopic evaluation of swallow
Secondary outcomes:
measure: Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration
timeFrame: Within 3 month follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts general Hospital
state: Massachusetts
Study officials:
affiliation: MGH, Harvard Medical School
name: Matthias Eikermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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: 10.1097/ALN.0b013e31829373fe.