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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01618240
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Swallowing Disorder; Aspiration; Long Term Ventilation	Other: Muscle Strength Measurement; Other: Ventilator

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Determining Predictors of Adequate Upper Airway Function in Long-term Ventilated Patients
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Long term ventilated subjects Muscle Strength Measurement, ventilator	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; Other: Ventilator; A mechanical ventilator is used to assist or replace spontaneous breathing.

Outcome Measures

Primary Outcome Measures

1. Muscle Strength [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 Outcome Measures

1. Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration [Within 3 month follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts general Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Matthias Eikermann, MD, PhD, MGH, Harvard Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Matthias Eikermann, Assistant Professor, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01618240
• Other Study ID Numbers: 2010P001919A
• First Posted: Jun 13, 2012
• Last Update Posted: Oct 13, 2014
• Last Verified: May 1, 2013

• Keywords provided by Matthias Eikermann, Assistant Professor, Massachusetts General Hospital: FEES; PAS; VPSR; MRC
• Additional relevant MeSH terms: Deglutition Disorders

Study Results

Participant Flow

Arm/Group Title	Long-term Ventilated Subjects
Arm/Group Description	Long-term (>10 days hours) ventilated subjects were included.
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Baseline Population
Arm/Group Description	Thirty long-term ventilated patients admitted in two intensive care units at Massachusetts General Hospital.
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	23 76.7%
>=65 years	7 23.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (14)
Sex: Female, Male (Count of Participants)
Female	14 46.7%
Male	16 53.3%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Muscle Strength
Description	We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients.
Time Frame	Within 24 hours of fiberoptic endoscopic evaluation of swallow

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Muscle Strength Measurement
Arm/Group Description	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
Measure Participants	30
Clinically significant muscle weakness (<48)	20 66.7%
No clinically significant muscle weakness (>=48)	10 33.3%

2. Secondary Outcome

Title	Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration
Time Frame	Within 3 month follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Muscle Strength Measurement
Arm/Group Description	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
Measure Participants	20
Symptomatic aspiration	14 46.7%
No symptomatic aspiration	6 20%

Adverse Events

Arm/Group Title	Long-term Ventilated Subjects
Arm/Group Description	30 consented long-term ventilated patients
All Cause Mortality
	Long-term Ventilated Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Long-term Ventilated Subjects
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Long-term Ventilated Subjects
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.