Early Progressive Mobility in the CVICU: Assessing Current Status

NCT ID: NCT01295541

Last Updated: 2011-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The current study is proposed to assess the frequency and type of progressive mobility procedures currently performed in the CVICU The study will evaluate the type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing. Other outcome measures will be the days of required mechanical ventilation, and current ICU length of stay and cost to treat.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This will be a descriptive 4 month study of standard care practice. Patients who meet the inclusion / exclusion criteria for study will be enrolled (Waiver of informed consent is requested) and followed for a maximum of 28 days. The type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing will be recorded. Weight bearing will be defined as standing for at least 1 minute. ICU LOS, Ventilator Days will be assessed at ICU discharge for study patients. Barriers to PM procedures will also be assessed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immobility and Weakness Associated With Long Intensive Care Unit Stays

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

4 months of observation

CVICU

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Mobilization is contraindicated by Patient's condition. Such as hip fractures or other injury that would impede standing posture.
* Patient weighs less than 70 pounds or more than 440 pounds
* Mobilization is contraindicated by patient's condition or physician's orders exist that prevent the patient from participating in the mobility protocol.
* Patient was unable to walk or stand without assistance prior to ICU admission.
* Patient was cognitively unable to follow verbal commands prior to ICU admission.
* Patients current diagnosis includes acute stroke with neurologic impairment
* Patient's current diagnosis includes drug overdose.
* Patient has "Do not resuscitate" orders and/or is at an end stage terminal disease state.
* Patient requires a specialty bed or mattress.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hill-Rom

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hill-Rom

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Leslie Culpepper, MSN, RN

Role: PRINCIPAL_INVESTIGATOR

The Medical Cneter of Central Georgia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical College of Central Georgia

Macon, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CR-2009-05a

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Post-stroke Perturbation Training
NCT04855032 COMPLETED NA