Observational Study of Expected ARF Recovery



Status:Enrolling by invitation
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:January 22, 2019
End Date:July 2022

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Observational Study of Expected Acute Respiratory Failure (ARF) Recovery

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 discharge.

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 expectations for functional recovery will be assessed before hospital
discharge via a standardized questionnaire containing a visual analogue scale and questions
about expected ability and importance of being able to perform activities of daily living and
instrumental activities of daily living in 6 months. At 6 months, participants will be
re-contacted by phone. Study staff will administer questionnaires to assess whether patient
expectations have been met. Quality of life will be assessed using the WHOQOL-BREF and the
EQ-5D-VAS.

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
4
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Somnath Bose, MD
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Principal Investigator: Samuel M Brown, MD MS
Phone: 801-507-4606
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Murray, UT
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: James Jackson, PhD
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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