Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04203953 |
| Other study ID # |
201910048RINB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 3, 2019 |
| Est. completion date |
August 21, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
National Taiwan University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Background:
Early mobilization is a component of the ABCDE bundle (Awaken from sedation; Breathe
independently from ventilator; Choice of sedation; Delirium management; Early mobilization),
an interdisciplinary, patient-centered strategy to facilitate evidence-based practices in
intensive care unit (ICU) settings. In patients who underwent early mobilization, specific
benefits were fewer ventilator days, fewer ICU and hospital days, fewer hospital
complications, less sedation and delirium days, and improved in-hospital functional outcomes.
Despite the fact that several lines of evidence demonstrated the safety and efficacy of early
mobilization in the ICU, studies conducted in neurological or trauma ICU settings are scarce,
possibly because of safety considerations such as physiologic instability (hemodynamic or
intracranial pressure) and invasive device integrity. It has only recently been suggested
that such programs are effective, safe, and potentially beneficial in critically ill
neurological patients. Nevertheless, there is no set protocol in place for moving these
patients, nor any suggested parameters to monitor.
Evidence regarding early mobilization has been based on reports from general medical and
surgical ICU environments, rather than from neurosurgical ICU (NSICU) or trauma ICU settings.
In NSICU patients with acute brain injury mostly, safety during mobilization could be
compromised because of hemiparesis or hemiplegia, cognitive impairment, tenuous intracerebral
pressure and cerebral perfusion, or dislodgement of cerebral monitoring or other indwelling
devices. In trauma ICU, trauma patients often have extensive orthopedic and neurosurgical
injuries, creating additional barriers to mobility. Little is known about the potential
effects of mobilizing patients with acute brain or server injuries admitted to the trauma
ICU. In one pre- and post-intervention research study of early mobilization in patients with
neurologic injury treated in a ICU, mobility levels increased post-intervention, without
adverse events. The results also supported the notion that progressive early mobilization
program leads to shorter ICU and hospital length of stay (LOS), fewer patient restraint days,
and fewer hospital-acquired infections. Another relevant study showed that implementation of
a progressive mobility algorithm was safe and was associated with a higher likelihood of
mobilization in the first week after spontaneous intracerebral hemorrhage (ICH) in the
neurological ICU. For trauma patients, previous studies demonstrated the safety of a mobility
protocol in a trauma and burn ICU and, additionally, showed a decrease in airway, pulmonary,
and vascular complications. Results from another study revealed favorable functional outcomes
for patients involved in a structured mobility program with physical therapy in the
neuro/trauma ICU. Overall, the lack of available evidence highlights the fact that there
remains much research to be done regarding early rehabilitation for patients in the trauma
ICU and there are specific questions to be answered regarding the timing of intervention, the
intensity and the type of exercises.
Previously, in the trauma ICU of National Taiwan University Hospital (NTUH), the referral of
patients for physical therapy and mobilization occurred at the discretion of the medical
providers with very low the proportion of patients with physical therapist (PT)
consultations. Therefore, the overall objective of this quality improvement (QI) project will
be to evaluate a structured and interdisciplinary early rehabilitation and progressive
mobility protocol for critically ill patients in a trauma ICU.
Purpose： The goals of the project will be to provide a standardized, evidence-based,
interdisciplinary mechanism to increase each patient's activity level safely while
simultaneously initiating and promoting a culture of mobility. The investigators will also
conduct this project to evaluate the effects of this early mobilization program on the
outcomes of patients in the trauma ICU.
Intervention： Overview of Project Setting, Design, and Patients The project initiative will
be developed using an established and structured QI framework (described below in "QI
Process") and evaluate using an observational, pre-post design. A nonprobability, convenience
sampling strategy will be used for program evaluation. The setting will be the trauma ICU in
National Taiwan University Hospital, 8-bed trauma ICU unit. PT and Occupational therapist
(OT) consultations and treatments will be available when ordered by medical providers. Both
the assessment method and training program (progressive mobility protocol for all critically
ill patients) are current procedure of the early rehabilitation team. The project will be
implemented using equipment resources, the Sara Combilizer or Sara Plus (Arjo Huntleigh,
GETINGE group).
This study will consist of a retrospective, pre- QI Process period (January 1, 2018, through
June 30, 2019) followed by a prospective QI-Process phase (December 31, 2019-December 31,
2022). We conducted a retrospective review covering the period from January 1, 2018, through
June 30, 2019, of patients >20 years of age admitted to the trauma ICU (more than 3 days),
who were alive more than 7 days after ICU admission. Charts from the first consecutive 100
patients who meet aforementioned criteria will be reviewed retrospectively before
implementation of the QI Process by using the daily medical records and daily assessment
reports of nursing built into the electronic medical records of NTUH. The prospective
population will consist of patients above 20 years old who required trauma ICU admission for
three or more days with PT or/with OT consultations from December, 2019, through December 31,
2022.
QI Process The structured QI model of the project initiative will create a change in practice
using the "four Es" approach: engage, educate, execute, and evaluate. To achieve this, a
collaborative interdisciplinary QI team, the EM Working Group, will be created. Participation
in the EM Working Group will be open to all interested the ICU staff. Active participants
will include at least one champion from each of the following groups: physicians, nurse
practitioners, nurses, OT, PT and rehabilitation physicians. This core group of individuals
will meet on a weekly basis over 2 months to plan (engage and educate) the QI project prior
to its execution and evaluation. First, champions from the rehabilitation team will conduct
focus groups with all stakeholders from their respective disciplines to present the problem
and identify trauma ICU -based facilitators and barriers to early mobilization. Explain why
the interventions are important. Bedside staff will better understand the importance of
mobility if there is a clear understanding that mobility will increase safety, decrease
secondary complications and improve outcomes, ultimately shortening hospital stays and cost
of care. Second, the rehabilitation team will develop guidelines for mobilization in the
trauma ICU based on the feedback provided from the focus groups and prior literature
regarding early mobilization. Third, educational resources will be developed for all trauma
ICU staff. Finally, the interdisciplinary team will determine valid and feasible outcome
measures based on previously published early mobilization QI studies to evaluate performance.
Staff Educational Resources To ensure competence in treating this patient population,
literature will be reviewed on the efficacy and safety of early mobilization and
interventions. Then, educational resources will be presented in meetings, presentations, or
online communications. A formal written procedure will also be available to staff. A relevant
online learning module regarding early rehabilitation in critically ill patients will be
created.
The 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.
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. Safety criteria for early mobilization will be evaluated the following
before intervention: Glasgow Coma Scale (GCS) above 6; raised intracranial pressure<20mmHg;
no cardiopulmonary arrest; no acute myocardial infarction; no rapidly developing
neuromuscular disease; no pregnancy; no ruptured or leaking aortic aneurysm; and no ICU
admission for palliative care or no medical orders specifying alternate activities.
It does not preclude the patient receiving assistance from staff or equipment. The protocol
will include an initial assessment by the physician on service to determine readiness to
participate in PT. If deemed appropriate, PT and OT consults will be requested. It will be
determined whether each patient's activity level will evaluated by the rehabilitation team.
PTs will facilitate active mobility, while range of motion, seating, and positioning will be
the purview of PTs, with OT collaboration as needed. The bedside PT will record this
information in the electronic record daily performances and goals note. The bedside PT will
also assess the appropriateness of the activity level throughout the day by the ICU mobility
scale. Activities may be implemented by nurses and/or therapists based on their specific
skills and provided equipment. The PT will provide guidelines for appropriate activities,
with the option to perform more advanced activities using equipment (Sara Combilizer or Sara
Plus) Note: individualized to the patient. PTs will teach the family how to do passive or
active range of motion, bed exercises, and sitting position in bed for the patient as well as
encourage the family to assist with these exercises when they visit. Early mobilization will
be provided once daily 5 days/week during the 30-minute family visiting time (morning or
afternoon visits).
Severe adverse events will be prospectively defined as falls, unplanned extubation, cardiac
arrest, loss of an invasively-inserted line and new-onset atrial or ventricular
tachyarrhythmia; all these will be recorded during mobilization sessions. The investigators
will define adverse events that will require a mobilization session to be suspended
prematurely a priori. These events include decrease in mean arterial pressure <60 mmHg or
decrease in oxygen saturation <88% for more than 3 minutes or occurrence of a new oxygen
requirement with a fraction of inspired oxygen >0.6. If an adverse event occurs during a
therapy session, the session will be immediately stopped and the attending physician will be
notified.
