Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300248
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2006-03-07
Brief Title:
Long-Term Results in Mechanically Ventilated Individuals With Acute Lung InjuryAcute Respiratory Distress Syndrome
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
The Improving Care of Acute Lung Injury Patients ICAP Study
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute lung injuryacute respiratory distress syndrome ALIARDS is a severe lung condition that causes respiratory failure Individuals with ALIARDS often require the use of a respirator or artificial breathing machine known as a mechanical ventilator while in an intensive care unit ICU Past research has shown that improved short-term clinical outcomes result from the use of a protective mechanical ventilation technique for the lungs This study will evaluate the effects of lower tidal volume ventilation and other aspects of critical illness and ICU care on the long-term clinical outcomes of individuals with ALIARDS
Detailed Description:
ALIARDS is a life-threatening condition that involves inflammation of the lungs and fluid accumulation in the air sacs which leads to low blood oxygen levels and respiratory failure Common causes include pneumonia septic shock and lung trauma Symptoms usually develop within 24 to 48 hours of the original injury or illness and most patients require immediate care in an intensive care unit ICU The main form of treatment for ALIARDS is the delivery of oxygen and a continuous level of pressure to the damaged lungs through mechanical ventilation Past research has shown that lower tidal volume ventilation LTVV a protective ventilator management technique in which lower volumes of oxygen are administered improves short-term clinical outcomes in individuals with ALIARDS However the long-term impact of LTVV remains unknown The purpose of this study is to evaluate the effects of LTVV on long-term outcomes in individuals with ALIARDS
This study will enroll individuals admitted to an ICU who have been recently diagnosed with ALIARDS Once enrolled participants medical records will be reviewed for demographic and medical information Participants will be examined to determine level of cognition and delirium Questionnaires will be used to assess the participants status prior to ICU admittance including level of hearing physical functioning quality of life employment and living status Questionnaires will be given to participants as well as a close contact to increase the reliability of feedback While in the ICU participants will receive normal clinical care Data on laboratory tests mechanical ventilator settings arterial blood gas values and medical status will be collected throughout the ICU stay Information regarding the medical staff-to-patient ratio and the use of different medical treatments and therapies will also be collected by reviewing medical records and interviewing nurses Follow-up evaluations lasting approximately four hours each will occur 3 6 12 24 36 48 and 60 months following the ALIARDS diagnosis At each follow-up visit participants will undergo a physical examination and standardized surveys and tests will be used to assess medical outcomes organ impairment pulmonary function mental function and quality of life If participants are unable to return to the research clinic for the follow-up evaluations visits may occur at their home or over the phone
The original 2-year follow-up duration for which participants were consented was subsequently extended to allow 5-year follow-up In recruiting these previously consented participants into the 5-year follow-up extension they will be randomized to selected recruitment strategies eg different mailing and telephone strategies in order to gain insight regarding the most effective methods of recruiting participants
This study will enroll individuals admitted to an ICU who have been recently diagnosed with ALIARDS Once enrolled participants medical records will be reviewed for demographic and medical information Participants will be examined to determine level of cognition and delirium Questionnaires will be used to assess the participants status prior to ICU admittance including level of hearing physical functioning quality of life employment and living status Questionnaires will be given to participants as well as a close contact to increase the reliability of feedback While in the ICU participants will receive normal clinical care Data on laboratory tests mechanical ventilator settings arterial blood gas values and medical status will be collected throughout the ICU stay Information regarding the medical staff-to-patient ratio and the use of different medical treatments and therapies will also be collected by reviewing medical records and interviewing nurses Follow-up evaluations lasting approximately four hours each will occur 3 6 12 24 36 48 and 60 months following the ALIARDS diagnosis At each follow-up visit participants will undergo a physical examination and standardized surveys and tests will be used to assess medical outcomes organ impairment pulmonary function mental function and quality of life If participants are unable to return to the research clinic for the follow-up evaluations visits may occur at their home or over the phone
The original 2-year follow-up duration for which participants were consented was subsequently extended to allow 5-year follow-up In recruiting these previously consented participants into the 5-year follow-up extension they will be randomized to selected recruitment strategies eg different mailing and telephone strategies in order to gain insight regarding the most effective methods of recruiting participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL088045 | NIH | None | httpsreporternihgovquickSearchR01HL088045 |
| P50HL073994-03 | NIH | None | None |