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Quality Improvement Intervention to Promote Early Mobilization in Trauma ICU

NCT04203953 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2021-11-03

No results posted yet for this study

Summary

Background: Despite the fact that many lines of evidence point to the safety and feasibility of early mobilization in medical or surgical ICUs, there remains limited evidence regarding the efficacy or outcome of mobilizing patients in trauma ICU. Given the lack of published literature or routine protocol for mobilizing this population in our institution, the investigators developed a formal protocol and quality improvement project.

Objective: To determine the flexibility and effects of an early mobilization project in a trauma ICU.

Design: Observational, pre-post design.

Setting: A eight-bed trauma ICU in a medical center in Taipei.

Patients: Critically ill adults admitted to the trauma ICU.

Intervention: This project will involve a routine care baseline phase to promote early mobilization of critically ill patients. The bedside physical therapist (PT) will assess the appropriateness of the activity level throughout the day. The PT will provide guidelines for appropriate activities, with the option to perform more advanced activities using equipment. Early mobilization will be provided once daily 5 days/week during the 30-minute family visiting time.

Outcome: The primary outcome measures will be as follows: (1) the proportion of patients with occupational therapist (OT) and/or PT consultations per ICU days 3, 7 and 14; (2) the time and types of mobilization activities performed at the day of ICU admission, the day of ICU discharge and the day of hospital discharge, including passive and active activities; (3) the Perme intensive care unit mobility score at the day of ICU admission, the day of ICU discharge and the day of hospital discharge; Secondary outcome measures will include the following: (1) the number of times and reasons for suspended activities; (2) mobilization-related adverse events.

Statistical Analysis: Unadjusted comparisons before and after implementation of the project will be performed using chi-square analysis, Fisher exact test, or the Wilcoxon signed rank test, as appropriate. A two-sided p-value less than 0.05 will be used to determine statistical significance.

Conditions

  • Patients Admitted to the ICU More Than 3 Days Post-onset

Interventions

OTHER

Early mobilization program

Early mobilization will be defined as any active exercise where the patients could assist with the activity using their own muscle strength and control that occurred within the first 7 days of trauma ICU admission and will be intended to maintain or restore overall function as well as being scored using the ICU mobility scale.15 The ICU mobility scale includes rolling, bridging, sitting, standing and walking, and upper and lower limb flexion and extension. In-bed therapies will include active or active-assist range of motion, bridge exercise, quadriceps setting, straight leg raising, rolling exercises and facilitation.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-03
Primary Completion
2021-07-30
Completion
2021-08-21

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04203953 on ClinicalTrials.gov