Investigating Modes of Progressive Mobility

Phase 2

Completed

• Conditions: Critical Care; Mechanical Ventilation; Intensive Care; Muscular Atrophy
• Interventions: Other: ETM protocol

• Registration Number: NCT00787098
• Lead Sponsor: Hill-Rom

Brief 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.

Detailed 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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Primary Completion: 2009-04
• Status Verified: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-02
• Last Update Posted: 2009-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• P:F ratio > 100
• FiO2 < 60% and PEEP less than 10 cmH20
• hemodynamic stability ten minutes after turning (i.e., heart rate (HR) and/or systolic blood pressure (BP) changes less than 20% of baseline)
• baseline (rest) vitals signs of HR 50-110
• mean arterial pressure (MAP) 60-100 mmHg
• peripheral oxygenation saturation (SpO2) greater than 88%
• Sufficient cognition for progression to levels 2-4 of ETM to assist with out of bed positioning or movement
• a high degree of dependency on others for positioning is acceptable
• there are no exclusions based on gender or minority status.

Exclusion Criteria

• End-stage muscular dystrophy
• myasthenia gravis
• new quadriplegia
• coma
• increased intracranial pressure
• unrepaired hip fracture and multiple lower extremity fractures
• Patients experiencing active titration of intravenous vasoactive medications (e.g. dopamine, epinephrine, or norepinepherine) will be excluded
• concurrent use of a continuous lateral rotation bed
• patients for high risk of death will also be excluded
• MICU admission following a hospital stay of >9 days in the past months
• age >80 in the presence of 2 or more life-threatening illnesses
• diagnosis of an active stage IV malignancy
• status post cardiac arrest
• diagnosis of intracerebral hemorrhage requiring mechanical ventilation
• subjects over 400 pounds can be excluded from mobilization based on the judgment of the bedside nurse or project manager; if the risk for staff or patient harm from moving a patient with excessive weight is considered likely, mobilization will not occur.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	ETM protocol	Identical procedures for date recruitment, consent and data collection will occur. In this phase, the Project Manager will promote the use of the ETM protocol through coaching (e.g., reminding staff of benefits of mobility, identification of available resources, or suggesting cessation of bedrest orders) and by participating in planning at least one 20-minute activity.

Primary Outcome Measures

Name	Time	Method
Compare immediate molecular and physiological patient responses to activity with responses to an ETM protocol.	1, 2, 3, 7, days then weekly

Secondary Outcome Measures

Name	Time	Method
A secondary aim is to identify strategies and conditions that promote or prevent ETM.	1, 3, 5, 7, days then weekly