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Completed

NCT Number: NCT01618240

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

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.

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Key information

Conditions

Swallowing Disorder Aspiration Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Long Term Ventilation Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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

Ventilator

Other

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

Primary outcomes

  1. Muscle Strength

    Time frame: Within 24 hours of fiberoptic endoscopic evaluation of swallow

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

Secondary outcomes

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

    Time frame: Within 3 month follow-up

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2012
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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