Investigating Modes of Progressive Mobility

Status Completed

Clinical Trial Summary

The purpose of this study is to compare the effects of specific activities with and without an early therapeutic mobility (ETM) protocol among patients who experience three or more days of mechanical ventilation. A second purpose is to examine staff/delivery system and patient factors that influence the initiation and progression of activity with and without an ETM protocol. The hypothesis is that ETM protocols will result in improved patient outcomes.

Clinical Trial Description

The specific aims of this study are to:

1. Compare patient responses to selected modes of therapy (activity) without and with an ETM protocol

1. Molecular responses: markers of inflammation interleukin (IL)-6 and IL-10

2. Physiological responses: peripheral oxygen saturation, heart rate, blood pressure, new dysrhythmias

3. Safety/Unsafe events including pain, fatigue, line or tube dislodgement, fall or near fall

2. Determine the associations between duration and level of activity/ETM achieved and outcomes:

1. occurrence of delirium

2. occurrence of ventilator associated pneumonia

3. occurrence of deep vein thrombosis or pulmonary emboli

4. occurrence of acquired pressure ulcer

5. muscle strength

6. number of days mechanically ventilated

7. discharge location (after ICU)

3. Describe strategies used in the ICU to initiate and implement activity with and without an ETM protocol

1. use of personnel such as registered nurses, physical therapists, respiratory therapist and nursing assistants

2. use of equipment such as a walker, lift device, belt or bed

3. perception of sufficient time and abilities

4. Describe patient factors that are associated with implementation of ETM

1. Potentially modifiable exemplars: sedation, site of vascular access, physician orders

2. Potentially nonmodifiable exemplars: weight, consciousness, hemodynamic instability, terminal condition

This is a prospective, longitudinal, repeated measures study with a control period, run-in period and intervention period. Data will be collected during all three periods for comparison. During the control period, patients will receive standard care. Standard care in this institution does not include a program of progressive or early mobility but does include activities similar to the ETM protocol, implemented at the discretion of the staff. During the run-in period, subjects will receive a mix of standard care and the intervention. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00787098
Study type	Interventional
Source	Hill-Rom
Contact
Status	Completed
Phase	Phase 2
Start date	November 2007
Completion date	July 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.