Status:
COMPLETED
Observational Study of Expected ARF Recovery
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Acute Respiratory Failure
Post Intensive Care Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational cohort study of the association between patient expectations for functional recovery and quality of life among acute respiratory failure survivors 6 months after hospital disc...
Detailed Description
This study will enroll adults who are diagnosed with acute respiratory failure during an ICU admission and discharged from the ICU alive. All participants will receive usual clinical care. Participant...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Respiratory failure managed in the ICU, where respiratory failure is defined as ≥1 of the following:
- Mechanical ventilation via an endotracheal tube ≥ 24 hours OR
- Non-invasive ventilation (CPAP, BiPAP) ≥ 24 consecutive hours\* provided for acute respiratory failure (not for Obstructive Sleep Apnea or other stable use) OR
- High flow nasal cannula with FIO2 ≥ 0.5 and flow rate ≥ 30 LPM for ≥ 24 consecutive hours\*
- \*Occasional rest periods of ≤ 1 hour each are not deducted from the calculation of consecutive hours.
- Expected by the clinical team to be discharged home alive
Exclusion
- Patient in ICU \< 24 hours
- Mechanical ventilation at baseline or mechanical ventilation solely for airway protection or obstruction
- Residing in a medical institution at the time of hospital admission
- Homeless / Prisoner / Primary residence not in the USA / Unable to communicate by telephone in English
- More than mild dementia (either known diagnosis of moderate or worse dementia or IQ-CODE \> 3.6; screening performed on patients \> 50 years old or with family reports of possible memory decline)
- Patient on hospice at or before time of enrollment
- Patients who, based solely on pre-existing medical problems (such as poorly controlled neoplasm or other end stage disease, including Stage IV heart failure or severe burns), would not be expected to survive 6 months in the absence of the acute respiratory failure.
- Patients with neurological injury either receiving treatment for intracranial hypertension or who are not expected to return to consciousness.
- Pregnancy
Key Trial Info
Start Date :
January 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03797313
Start Date
January 22 2019
End Date
December 1 2021
Last Update
December 15 2021
Active Locations (4)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Vanderbilt University
Nashville, Tennessee, United States, 37235
4
Intermountain Medical Center
Murray, Utah, United States, 84107