Quality of LifeNCT01817608
Weaning From Mechanical Ventilation in the ICU
An observational study of Quality of Life, run by Amal Jubran at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients receiving mechanical ventilation
Who may be able to join
- ICU patients who require mechanical ventilation for at least 2 days
- the ability to speak English
- willing to participate
Who cannot join
- patients who require mechanical ventilation at home before hospitalization
- patients previously requiring mechanical ventilation at an LTAC facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Chicago Health Sciences Division
Maywood, Illinois, 60153
About this study
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.
- Conditions
- Quality of Life
- Keywords
- sf-36, Katz
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life scores
SF-36, Katz, respiratory muscle strength and handgrip strength will be measured
Measured: up to one year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startSep 2004
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amal Jubran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amal Jubran, Loyola University
- Investigators
- Amal Jubran, MD, Principal investigator, Loyola Univ Chicago Health Sciences Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817608
- Sponsor's protocol ID
- 107589
- Status last verified
- Mar 2013
- First submitted
- 15 Mar 2013
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From Mechanical Ventilation in the ICU
- ClinicalTrials.gov ID
- NCT01817608
- Acronym / sponsor ID
- 107589
- Conditions
- Quality of Life
- Keywords
- sf-36, Katz
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Amal JubranUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients receiving mechanical ventilation
Key inclusion criteria (3 listed)
- ICU patients who require mechanical ventilation for at least 2 days
- the ability to speak English
- willing to participate
Key exclusion criteria (2 listed)
- patients who require mechanical ventilation at home before hospitalization
- patients previously requiring mechanical ventilation at an LTAC facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
quality of life scores
Time frame: up to one year after discharge
SF-36, Katz, respiratory muscle strength and handgrip strength will be measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Jubran, MD principal investigator
Loyola Univ Chicago Health Sciences Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Amal Jubran at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life scores (time frame: up to one year after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2013.