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

NCT ID: NCT01618240

Last Updated: 2014-10-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Swallowing Disorder Aspiration Long Term Ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Long term ventilated subjects

Muscle Strength Measurement, ventilator

Muscle Strength Measurement

Intervention Type 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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Ventilator

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthias Eikermann

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Eikermann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

MGH, Harvard Medical School

Locations

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Massachusetts general Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8721066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19374150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1745285 (View on PubMed)

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.

Reference Type RESULT
PMID: 23584384 (View on PubMed)

Other Identifiers

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2010P001919A

Identifier Type: -

Identifier Source: org_study_id

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