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Active Not Recruiting
NCT03738774
Addressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID)
Conditions: Post Intensive Care Syndrome
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: Vanderbilt University Medical Center
Location: Johns Hopkins Hospital Baltimore Maryland
Summary
This study will assess the relationship between early unmet needs after hospital discharge and subsequent clinical outcomes among survivors of acute respiratory failure. The investigators hypothesize that early unmet needs are associated with poor outcomes at three months.
Eligibility Criteria
Inclusion Criteria:
1. Respiratory failure:
* Mechanical Ventilation via endotracheal tube/tracheostomy ≥ 24hrs
* continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP) ≥ 24 consecutive hrs (provided for acute respiratory failure not for Obstructive Sleep Apnea or other stable use)
* High flow nasal cannula ≥ 24 consecutive hrs (FIO2 ≥ 0.5 and flow rate ≥ 30 L/min)
2. Expected to be discharged home alive
3. Within the pandemic expansion cohort, COVID-19 status (defined as a positive result on an appropriately validated molecular diagnostic assay for infection with SARS-CoV-2) will be used to guide enrollment
Exclusion Criteria:
* Lack of informed consent
* Patient in the ICU \< 24hrs
* Mechanical ventilation at baseline
* Residing at a medical institution at the time of hospital admission
* Homelessness
* Primary residence not in USA
* Prisoner
* More than mild dementia (either known diagnosis of moderate or worse dementia or Informant Questionnaire on Cognitive Decline in the Elderly (IQ-CODE) \> 3.6; screening performed on patient \> 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 six months in the absence of the acute respiratory failure.
* Patient with neurological injury either receiving treatment for intracranial hypertension or who are not expected to return to consciousness.
* Unable to communicate by telephone in English or Spanish
* Patients mechanically ventilated solely for airway protection or obstruction
Source: ClinicalTrials.gov (NCT03738774). StuddyBuddy aggregates publicly available trial information.