Investigating Modes of Progressive Mobility

NCT00787098 | Completed Phase 2

• 1 other identifier: CR-0076
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Care; Mechanical Ventilation; Intensive Care; Muscular Atrophy

Keywords

therapeutic mobility; acute care; nursing; inflammatory markers

Outcome Measures

Primary Outcomes (1)

• Compare immediate molecular and physiological patient responses to activity with responses to an ETM protocol.

  1, 2, 3, 7, days then weekly

Secondary Outcomes (1)

• A secondary aim is to identify strategies and conditions that promote or prevent ETM.

  1, 3, 5, 7, days then weekly

Study Arms (2)

1

NO INTERVENTION

RA begins data collection with chart review for demographic and explanatory variables, collects data for baseline muscle strength. During standard care period, PM will obtain information about the plan for activity for enrolled patients (turning, complete or partial weight-bearing i.e., reverse Trendelenberg positioning, ROM, sitting and walking) through discussion with the direct providers. RA will interview one provider about factors which influence the decision to implement activity or provide bedrest, including the presence of orders for bedrest or physical therapy. If activity is planned, the PM will observe and record the type and duration of activity, drawing serum biomarkers 20 minutes before and 20 minutes after the activity. If no activity is planned or activity duration is less than 10 minutes, serum for only baseline inflammatory biomarkers will be drawn. The RA will collect outcomes data within 24 hours of discharge from the ICU.

2

EXPERIMENTAL

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.

Other: ETM protocol

Interventions

ETM protocol OTHER

ETM is 4 levels. Level 1, each receives repositioning from lateral to supine positions at even hours, totaling 60 minutes of activity/positioning over 24 hours. If tolerated, two periods of 20 minutes of supine position with a reverse trendelenberg position of 15-20 degrees will be used to promote orthostasis. Level 2 is turning every 2 hours, positioning in reverse trendelenberg at 15-25 degrees as tolerated, active resistance with ICU staff for 20 minutes daily for a total of 60-80 minutes of activity/positioning daily. At Level 3, 2 times 20 minutes of a sitting are added to active ROM and inbed turning (estimated 80-100 total minutes of activity daily). Sitting is in bed or with non-weightbearing assisted transfer to chair with backrest elevation at 75-90 degrees and legs in a dependent position. Level 3 interventions; minimal weight-bearing. Level 4, weight-bearing transfer to chair and ambulation are added to inbed turning.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hill-Rom: lead

Related Publications (1)

• Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.

  PMID: 18596631 BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Chris Winkelman, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 3, 2009

Record last verified: 2009-07