Study of Therapeutic Exercise in Acute Respiratory Failure to Improve Neuromuscular Disability Trial

Not Applicable

Completed

• Conditions: Critical Illness; Acute Respiratory Failure
• Interventions: Behavioral: Early mobilization intervention

• Registration Number: NCT03863470
• Lead Sponsor: University of Pennsylvania

Brief Summary

This is a stepped-wedge, cluster randomized, trial evaluating the effect of an early goal-directed mobilization intervention for ICU patients with acute respiratory failure within 12 medical and surgical ICUs across 4 hospitals in the University of Pennsylvania Health System. The investigators will conduct a 54-week trial to measure the effect of the intervention on multiple patient-centered outcomes of patient physical function and cognition, in addition to ICU and hospital length of stay and duration of mechanical ventilation compared to usual care.

Detailed Description

The STAND trial aims to measure the effect of an early goal-directed mobilization algorithm versus usual care for ICU patients with acute respiratory failure in the medical and surgical ICUs across University of Pennsylvania Health System (UPHS) with respect to patient-centered outcomes of patient physical function and cognition as well as multiple secondary clinical outcomes. To achieve this goal, the investigators will conduct a 54-week stepped-wedge, cluster randomized, trial to test the intervention during the course of providing usual care among a large and diverse population of patients admitted to 12 ICUs across 4 hospitals within UPHS. The intervention is an early mobilization protocol implemented during a patient's stay in the ICU. It involves three steps: 1) the clinical team will set a standardized mobility goal for each patient during morning rounds and display the goal on the patient's door; 2) a facilitator will be established in the ICU to communicate mobility goals and activities across clinical personnel shifts; 3) patient mobility scores will be displayed to clinical and administrative staff in the ICU via the ICU board. Approximately 1,500 adult patients with continuous mechanical ventilation for ≥48 hours (without interruption) and baseline independent ambulatory status will be enrolled. Participating ICUs will be randomized into 6 clusters of 2 ICUs each. Each ICU contributes a minimum of 12 weeks of data under the usual care control condition prior to implementing the early mobilization intervention. Then, using the stepped-wedge design, all ICUs will implement the intervention in 6-week intervals with the order and timing of implementation determined by random assignment. By the end of the trial, all ICUs will have utilized the intervention for at least 12 weeks. The primary outcome is peak patient activity level as measure by the ICU mobility score (IMS) at ICU discharge. Secondary outcomes include an array of clinical outcomes.

Study Timeline

• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-03-01
• Study Start: 2019-03-04
• Study First Posted: 2019-03-05
• Primary Completion: 2020-03-15
• Study Completion: 2020-07-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1917

Inclusion Criteria

• Age ≥18 years old; AND
• Admission to 1 of 12 participating ICUs; AND
• Continuous mechanical ventilation for ≥ 48 hours (without interruption); AND
• Baseline independent ambulatory status

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Exclusion Criteria

• Admitting diagnosis of any of the following conditions:

  • Cardiopulmonary arrest
  • Raised intracranial pressure
  • Acute neurological admission diagnosis
  • Subarachnoid hemorrhage
  • Ischemic stroke

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early mobilization intervention	Early mobilization intervention	The clinical team will set a standardized mobility goal for each patient during morning rounds and display the goal on the patient's door. A facilitator will be established in the ICU to communicate mobility goals and activities across clinical personnel shifts. Patient mobility scores will be displayed to clinical and administrative staff in the ICU via the ICU board.

Primary Outcome Measures

Name	Time	Method
Peak hour patient activity level	Within 48 hours of ICU discharge	Peak hour patient activity level as measured by the ICU mobility score (IMS) at ICU discharge. IMS score ranges from 0 to 10.

Secondary Outcome Measures

Name	Time	Method
ICU length of stay	From ICU admission to ICU discharge, approximately 3 days	ICU length of stay (days)
Neurological function	From hospital admission to hospital discharge, approximately 5 days	Composite measure of delirium and coma free days
Hospital length of stay	From hospital admission to hospital discharge, approximately 5 days	Hospital length of stay (days)
Richmond Agitation-Sedation Scale (RASS)	From hospital admission to hospital discharge, approximately 5 days	RASS score at time of first spontaneous breathing trial. RASS score ranges from -5 (unarousable) to +4 (combative); A score of 0 = alert and calm.
ICU mortality	From ICU admission to ICU discharge, approximately 3 days	ICU Mortality
Duration of mechanical ventilation	From hospital admission to hospital discharge, approximately 5 days	Duration of time spent on continuous mechanical ventilation (hours)
Duration of time spent in deep sedation	From hospital admission to hospital discharge, approximately 5 days	Duration of time spent in deep sedation (hours)

Trial Locations

Locations (4)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Chester County Hospital; 🇺🇸 West Chester, Pennsylvania, United States

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States