CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Muscle Strength Measurement +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01618240
NCT01618240N/ACompleted

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

Massachusetts General Hospital·observational·Posted Jun 13, 2012·Updated Oct 13, 2014

In Brief

An observational study evaluating Muscle Strength Measurement and Ventilator for Swallowing Disorder and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 13, 2012
Enrollment StartJan 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.1 years ago

Interventions

Muscle Strength Measurementother

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

Ventilatorother

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