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Trial registered on ANZCTR


Registration number
ACTRN12614000763640
Ethics application status
Approved
Date submitted
30/06/2014
Date registered
17/07/2014
Date last updated
16/04/2019
Date data sharing statement initially provided
16/04/2019
Date results information initially provided
16/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study of a randomised controlled study of the Awakening and Breathing trial Coordination; Delirium monitoring and management; and Early exercise and mobility (ABCDE) bundle to improve functional and cognitive capacity in ventilated critically ill patients
Scientific title
A feasibility study of a randomised controlled study of the Awakening and Breathing trial Coordination; Delirium monitoring and management; and Early exercise and mobility (ABCDE) bundle to improve functional and cognitive capacity in ventilated critically ill patients
Secondary ID [1] 284887 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 292328 0
Invasive mechanical ventilation 292329 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292664 292664 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Awakening and Breathing Trial Coordination- at 08.30 every day following a safety assessment:
A. The mechanically ventilated patient will undergo a spontaneous breathing trial daily.
B. The mechanically ventilated patient receiving a continuous sedative infusion will receive both a spontaneous awakening trial (SAT) and spontaneous breathing trial (SBT) daily.
C. An ICU Registered Nurse (RN) will perform the spontaneous awakening and breathing trial.
D. The Consultant Intensivist will make the decision to extubate the patient.

Delirium monitoring and management:
Every patient admitted to the ICU will undergo routine sedation and delirium assessment using standardized and validated assessment tools including Richmond Agitation and Sedation Scale (RASS) and Confusion Assessment Method (CAM) -ICU.

B. An RN will perform and record the results of the (RASS) every 4 hours.

C. An RN will perform and record the results of the Confusion Assessment Method-ICU (CAM-ICU) twice per day (tested at 08.00 and 20.00).

D. Each day during multidisciplinary rounds, the team will set a “target” RASS score for the patient to be maintained at for the following 24 hours.

E. Each day during multidisciplinary rounds, the team will use the acronym “THINK” if a patient is CAM positive (delirious).
Toxic situations and medications
Hypoxemia
Infection/sepsis (nosocomial), inflammation, immobilization
Non-pharmacological interventions (see below)
K+ or other electrolyte interventions

F. The multidisciplinary team will employ non-pharmacologic interventions when treating a delirious patient including:

1. Eliminate or minimize risk factors
Administer medications judiciously; treat infections, treat dehydration and electrolyte disturbances,provide adequate pain control, maximize oxygen delivery , use sensory aids as appropriate, provide adequate nutrition

2. Provide a therapeutic environment
Foster orientation, caregiver identification; explain all activities; communicate clearly, provide appropriate sensory stimulation, adequate light; one task at a time; noise-reduction strategies.
Facilitate sleep
Foster familiarity, bring familiar objects from home;
Maintain consistency of caregivers; minimize relocations
Maximize mobility: avoid physical and chemical restraints; ambulate or mobilize patient early and often
Communicate clearly, reassure and educate family
Consider psychotropic medication only as a last resort

Early mobility and exercise

A. Patients are candidates for mobilization and exercise when the following (minimum) safety criteria are met:


M – Myocardial Stability
* No evidence of active myocardial ischaemia in the last 24 hours
* No dysrrhythmia requiring the administration of a new antiarrhythmics in the last 24 hours
O – Oxygenation adequate on:
* FiO2< 0.6
* PEEP < 10 cm H2O
V – Vasopressors minimal
* No increase dose of any vasopressor infusion for at least 2 hours
E – Engage to Voice
* Patients who do not respond to verbal stimulation (RASS 4-5) – Passive range of motion
* Patient responds to verbal stimulation (i.e. RASS > -3) – Early mobility and exercise
S – Safety
* Not receiving therapies that restrict mobility (open-abdomen)
* No injuries in which mobility is contra-indicated (e.g. unstable fractures)

B. Any other justification for not implementing the protocol must be documented specifically by the Consultant Intensivist.

C. The registered nurse can assess the patient's readiness for mobility in consultation with a physiotherapist if this service is available. Otherwise, the Registered Nurse will assess whether the patient meets the mobilization and exercise criteria.

D. Each patient is assessed upon admission to the unit, and those who qualify immediately begin on the protocol. Those who are not eligible are reassessed daily at 08.30. If activity has been halted due to an acute event the patient is re-evaluated each day until the protocol can be reinstated.

E. Each eligible patient is encouraged to be mobile at least once a day, with the specific level of activity geared to his or her readiness. Patients progress through a four level process, embarking on the highest level of physical activity they can tolerate, as outlined below:

Level 1:
If unable to lift arm against gravity:
* Passive range of motion three times per day (tested at 06.00, 13.00, 20.00)
* Active resistance physiotherapy (tested at 10.00, 18.00)
* Sitting position in bed 20 minutes three times per day (tested at 06.00, 13.00, 20.00)

Level 2:
If able to lift arm against gravity:
* Passive range of motion three times per day (tested at 06.00, 13.00, 20.00)
* Active resistance physiotherapy (tested at 10.00, 18.00)
* Sitting position in bed 20 minutes three times per day (tested at 06.00, 13.00, 20.00)
* Sitting on edge of bed daily (tested at 10.00)

Level 3:
If able to move leg against gravity:
* Passive range of motion three times per day(tested at 06.00, 13.00, 20.00)
* Active resistance physiotherapy (tested at 10.00, 18.00)
* Sitting position in bed 20 minutes three times per day (tested at 06.00, 13.00, 20.00)
* Sitting on edge of bed daily (tested at 10.00)
* Active transfer to chair once per day

Level 4:
If able to move leg against gravity and managed Level 3 the previous day:
* Passive range of motion three times per day (tested at 06.00, 13.00, 20.00)
* Active resistance physiotherapy (tested at 10.00, 18.00)
* Sitting position in bed 20 minutes three times per day (tested at 06.00, 13.00, 20.00)
* Sitting on edge of bed daily (tested at 10.00)
* Active transfer to chair once per day
* Ambulation (marching in place, walking in ICU corridors etc)


Intervention code [1] 289699 0
Rehabilitation
Comparator / control treatment
Standard Treatment:
Participants in the control group will receive standard medical, nursing, and allied health care. Standard care includes decisions made on a daily basis with no use of protocols: spontaneous breathing and awakening trials as determined by the Consultant Intensivist on duty; ad hoc observation and management of pain and delirium; once or twice daily passive and active exercise as determined by the physiotherapist of the day with patients generally remaining in bed if they are ventilated.
Control group
Active

Outcomes
Primary outcome [1] 292508 0
Functional Outcomes: The Physical Function ICU Test (Scored) will be used to measure the patient’s functional outcomes.
Timepoint [1] 292508 0
At both Intensive Care Unit and Hospital discharge
Primary outcome [2] 292509 0
Cognitive capacity will be measured with the Montreal Cognitive Assessment tool.
Timepoint [2] 292509 0
At both Intensive Care Unit and Hospital discharge
Primary outcome [3] 292611 0
The Barthel Index will be used to measure the patient’s functional outcomes.
Timepoint [3] 292611 0
At both Intensive Care Unit and Hospital discharge
Secondary outcome [1] 309125 0
Sedation will be measured using the Richmond Agitation Sedation scale
Timepoint [1] 309125 0
Every 4 hours whilst mechanically ventilated
Secondary outcome [2] 309126 0
Delirium status will be measured using the Confusion Assessment Method for ICU.
Timepoint [2] 309126 0
Every 12 hours whilst mechanically ventilated.

Eligibility
Key inclusion criteria
Participants will be eligible for this trial if they are aged over 18 years and have been mechanically ventilated for at least 48 hours.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are unable to comply with the intervention therapy prior to ICU admission: are unable to mobilise 3 meters with or without mobility device before acute ICU illness; have been diagnosed with cognitive impairment before acute ICU illness; have been diagnosed with neuromuscular disease that could impair ventilator weaning; have suffered an acute stroke during this admission; had cardiopulmonary resuscitation or do not resuscitate at admission; were on mechanical ventilation greater than 48 hrs before admission; have been readmitted to ICU within the current hospitalization; or are not expected to survive the current ICU admission.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2686 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 8383 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 289511 0
Government body
Name [1] 289511 0
Health and Medical research
Queensland Health
Address [1] 289511 0
Department of Health
Level 16
Charlotte Street
Queenland Health building
Brisbane QLD 4000
Country [1] 289511 0
Australia
Primary sponsor type
Individual
Name
Kellie Sosnowski
Address
Intensive Care Unit
Logan Hospital
CNR Loganlea and Armstrong Roads
Meadowbrook QLD 4131
Country
Australia
Secondary sponsor category [1] 288197 0
None
Name [1] 288197 0
Address [1] 288197 0
Country [1] 288197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291257 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 291257 0
Princess Alexandra Hospital
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 291257 0
Australia
Date submitted for ethics approval [1] 291257 0
05/08/2014
Approval date [1] 291257 0
05/12/2014
Ethics approval number [1] 291257 0

Summary
Brief summary
The overall purpose is to evaluate the feasibility of conducting a study to find out whether ventilated adult patients admitted to the Intensive Care Unit (ICU) who receive a bundle of early rehabilitation strategies will have improved functional and cognitive capacity when they are discharged from both the ICU and hospital compared to a group receiving standard care
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49550 0
Ms Kellie Sosnowski
Address 49550 0
Intensive Care Unit
Logan Hospital
Cnr Armstrong & Loganlea Road
Meadowbrook QLD 4131
Country 49550 0
Australia
Phone 49550 0
+61 (07) 3299 8049
Fax 49550 0
Email 49550 0
Kellie.Sosnowski@health.qld.gov.au
Contact person for public queries
Name 49551 0
Ms Kellie Sosnowski
Address 49551 0
Intensive Care Unit
Logan Hospital
Cnr Armstrong & Loganlea Road
Meadowbrook QLD 4131
Country 49551 0
Australia
Phone 49551 0
+61 (07) 3299 8049
Fax 49551 0
Email 49551 0
Kellie.Sosnowski@health.qld.gov.au
Contact person for scientific queries
Name 49552 0
Ms Kellie Sosnowski
Address 49552 0
Intensive Care Unit
Logan Hospital
Cnr Armstrong & Loganlea Road
Meadowbrook QLD 4131
Country 49552 0
Australia
Phone 49552 0
+61 (07) 3299 8049
Fax 49552 0
Email 49552 0
Kellie.Sosnowski@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be available on request
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
In total, 30 (81.1%) of 37 eligible participants consented and were randomised to the intervention group (n=15) or the control group (n=15). Of these, 23 (76.6%) participants successfully completed the 90-day post discharge assessment. A lengthy recruitment period of 8 months was related to overly stringent inclusion and exclusion criteria. Intervention adherence exceeded defined success rates with participation in awakening and breathing trials, delirium monitoring and exercise interventions performed on 80.2, 97.4 and 90.2% of ventilated days respectively. Outcome assessments were successfully and accurately performed at ICU and hospital discharge and 90-day post-hospital discharge. Intervention participants were deemed to be delirious on 39.6% of mechanically ventilated days indicating a requirement for a scripted regime to prevent delirium.