Observational Study of Expected ARF Recovery (OSEAR)

Johns Hopkins University

Status: Completed

Conditions: Post Intensive Care Syndrome; Acute Respiratory Failure

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03797313

00181895 (Other Identifier)

IRB00197235

K01HL141637-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 2 patient groups

Patient's expectations met at Hospital discharge

Description:

ARF survivors whose expectations for recovery at hospital discharge are fully met 6 months later.

Patient's with unmet expectations at Hospital Discharge

Description:

ARF survivors whose expectations for recovery at hospital discharge are not fully met 6 months later.