Observational Study of Expected ARF Recovery

Acute Respiratory Failure Clinical Trial

— OSEAR  

Official title:

Observational Study of Expected Acute Respiratory Failure (ARF) Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797313
• Other study ID #: IRB00197235
• Secondary ID: 00181895K01HL141
• Status: Completed
• Start date: January 22, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 discharge.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Post Intensive Care Syndrome
• Respiratory Distress Syndrome
• Respiratory Insufficiency

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Intermountain Medical Center	Murray	Utah
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (29)

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Kamdar BB, Huang M, Dinglas VD, Colantuoni E, von Wachter TM, Hopkins RO, Needham DM; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network. Joblessness and Lost Earnings after Acute Respiratory Distress Syndrome in a 1-Year National Multicenter Study. Am J Respir Crit Care Med. 2017 Oct 15;196(8):1012-1020. doi: 10.1164/rccm.201611-2327OC. — View Citation

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life measured using the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF) after hospital discharge	WHOQOL-BREF is a measure of overall quality of life that evaluates satisfaction with important aspects of life rather than of health. The instrument contains 26 items across 4 domains, and requires approximately 5 minutes to administer over the phone. The 26 items in the WHOQOL-BREF are scored in four domains: physical, psychological, social relations, and environment, with between 3 and 8 items in each domain and two "benchmark" items addressing overall QoL. Transforming the raw scores results in a domain score between 0 - 100, enabling comparisons between domains with different numbers of items. Higher scores indicate greater participant satisfaction with their quality of life and lower scores indicate worse satisfaction with quality of life.	6 months after hospital discharge
Secondary	Patient expectation error measure using EQ-5D VAS	A secondary analysis will estimate patient expectation error, defined as the difference between the health-related quality of life score expected at hospital discharge and the actual health related quality of life score assessed using the EQ-5D VAS 6 months after hospital discharge. The EQ-5D VAS ranges from 0 to 100 with 0 representing the worst imaginable health state and 100 representing the best imaginable health state.	6 months after hospital discharge