NCT02533622

Brief Summary

Despite the known complications of immobility for ICU patients, compliance to mobility protocols is lacking in many institutions. Significant barriers have been described to compliance to up in chair and weight bearing orders in the ICU. Recent studies indicate that if progressive mobility is performed for acutely ill ICU patients they may have a reduced ICU length of stay, reduced overall hospital length of stay, incur lower hospital costs, and reduce the rate of some medical complications and increase functionality post ICU discharge. The current protocol seeks to understand whether or not the TotalCare® P500 Bed System and the Liko Lift can remove some of the barriers associated with progressive mobility compliance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

March 22, 2012

Last Update Submit

August 24, 2015

Conditions

Keywords

progressive mobility

Outcome Measures

Primary Outcomes (1)

  • First out of bed, which is to be defined as the first time that a patient stands whether assisted or not for > 1 minute.

    at ICU discharge (current avg LOS = 6 days)

Secondary Outcomes (7)

  • ICU length of stay

    at ICU discharge (current avg LOS = 6 days)

  • Days of Mechanical Ventilation assessed as time to extubation. Extubation is to be defined as the time when the ET tube is removed from the airway

    at ICU discharge (current avg LOS = 6 days)

  • Compliance with, Number and Duration of Up in Chair episodes. Patients will be considered compliant if they complete 100% of prescribed episodes.

    at ICU discharge (current avg LOS = 6 days)

  • ICU readmission rate (within 30 days)

    at ICU discharge (current avg LOS = 6 days)

  • Incidence of nosocomial pressure ulcers and change in existing pressure ulcers

    at ICU discharge (current avg LOS = 6 days)

  • +2 more secondary outcomes

Study Arms (2)

Standard of care

Patients admitted to the ICU will receive current standard of care related to mobility

Progressive mobility

patients admitted to the ICU will receive mobility per Progressive Mobility protocol using TotalCare beds and lifts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to the Medical ICU

You may qualify if:

  • Patient is ≥ 18 years old.
  • Patient has been admitted to the ICU for less than 3 days prior to study enrollment
  • Patients require mechanical ventilation for \> 48 hours

You may not qualify if:

  • Patient has an unstable spinal injury.
  • Patient weighs less than 70 pounds or more than 450 pounds
  • Mobilization is contraindicated by Patient's condition. Such as hip fractures or other injury that would impede standing posture.
  • Patient was unable to walk without assistance prior to ICU admission.
  • Patient was cognitively impaired prior to ICU admission.
  • Patient has experienced acute stroke with neurologic impairment
  • Patient's primary diagnosis is drug overdose.
  • Patient has Comfort Care Measures/End of Life orders and/or is at an end stage terminal disease state.
  • Patient requires a bed other than the standard care bed for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Mary J Tracy, RN, MSN

    Holy Name Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

August 27, 2015

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

January 1, 2013

Last Updated

August 27, 2015

Record last verified: 2015-08

Locations