NCT01817608

Brief Summary

The investigators objective is to assess quality of life and functional outcome in patients requiring short-term mechanical ventilation. Additionally, the investigators plan to measure the recovery of peripheral muscle strength and respiratory muscle strength during recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2004

Longer than P75 for all trials

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

September 1, 2004

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
Last Updated

March 25, 2013

Status Verified

March 1, 2013

Enrollment Period

6.8 years

First QC Date

March 15, 2013

Last Update Submit

March 20, 2013

Conditions

Quality of Life

Keywords

sf-36Katz

Outcome Measures

Primary Outcomes (1)

  • quality of life scores

    SF-36, Katz, respiratory muscle strength and handgrip strength will be measured

    up to one year after discharge

Eligibility Criteria

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

ICU patients receiving mechanical ventilation

You may qualify if:

  • ICU patients who require mechanical ventilation for at least 2 days
  • the ability to speak English
  • willing to participate

You may not qualify if:

  • patients who require mechanical ventilation at home before hospitalization
  • patients previously requiring mechanical ventilation at an LTAC facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Chicago Health Sciences Division

Maywood, Illinois, 60153, United States

Location

Study Officials

  • Amal Jubran, MD

    Loyola Univ Chicago Health Sciences Division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Faculty

Study Record Dates

First Submitted

March 15, 2013

First Posted

March 25, 2013

Study Start

September 1, 2004

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 25, 2013

Record last verified: 2013-03

Locations

US(1)