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Trial registered on ANZCTR


Registration number
ACTRN12613000611729
Ethics application status
Approved
Date submitted
15/05/2013
Date registered
28/05/2013
Date last updated
28/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Goal – directed Sedation and Mobilisation in Intensive Care (GoSaM)
Scientific title
Does a goal-directed sedation and mobilisation protocol improve functional activity levels (in ICU and at hospital discharge) in invasively ventilated adult intensive care patients compared to usual sedation and mobilisation management?
Secondary ID [1] 282512 0
Nil
Universal Trial Number (UTN)
U1111-1142-5516
Trial acronym
GoSaM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This study includes a heterogeneous group of ventilator-dependent patients, rather than 1 discrete health problem. However, the problems studies in this group include:

Functional impairment as a consequence of ICU admission 289169 0
Physical inactivity in ventilator-dependent adults 289170 0
Sedation in ventilator-dependent adults 289171 0
Delirium in ventilator-dependent adults 289172 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289493 289493 0 0
Physiotherapy
Anaesthesiology 289494 289494 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves three phases:

i. Observational Phase
Enrolled patients will be studied for five months of current usual practice using the unit’s current sedation and mobilisation practices.

ii. Mobilisation Target Phase
Enrolled patients will be studied for five months following the introduction of the physiotherapy mobilisation flowchart, targets and contraindications and the nursing mobilisation guidelines, targets and contraindications. Mobilisation procuderes outlined in the targeted mobilisation protocol does not differ from current practice by senior physiotherapy staff in the ICU. The aim is to provide consistency with the mobilisation procedures regardless of the presence of senior staff. The Physiotherapist Mobilisation Flow Chart commences with assessing whether the patient is awake and alert. If the patient is not awake and there are no contraindications to mobilisation the patient follows nursing mobilisation guidelines and is for passive mobilisation (PM) i.e. a sling transfer to sit-ou-of-bed (SOOB). If there is a contraindication to mobilisation the patient remains rest-in-bed. If the patient is awake and alert and there is no contrainidications to mobilisation a strength and functional assessment will be completed by physiotherapists. Based on this assessment patients will be allocated to either Phase 1 Rehabilitation (P1R) which will include sitting balance, strengthening exercises, tilt table etc or Phase 2 Rehabilitation Supported Weight Bearing (P2RSWB) which involves mobilisationu using gait harness or Phase 2 Rehabilitation Active Weight Bearing (P2RAW) which involves no gait harness. Phase 2 Rehabiliation will include sit-to-stand practice, marching on the spot and mobilisation away from the bedspace +/- gait aid. Mobilisation targets will be set daily for each patient after review by a physiotherapist. The target in the nursing mobilisation guidelines is for daily Passive Mobilisation (PM) i.e. sling transfer to SOOB for a minimum of 4 hours. P1R and P2R targets are as for a minimum daily episode of rehabilitation with a physiotherapist and SOOB for a minimum of 4 hours.

CONTRAINDICATIONS TO MOBILISATION
Neurological: 1/Receiving active treatment for intracranial hypertension e.g. EVD open to drainage, Codman’s monitor, sedation & paralysis, 2/ Presence of subgaleal drain, 3/Uncontrolled seizures, 4/Acute spinal cord injury prior to fixation and clearance from surgical team, 5/ Open lumbar drain 6/Vasospasm unless cleared to mobilise by neurosurgical team

Respiratory: 1/ PEEP >15, FiO2 >0.6, pre-treatment RR >35 breaths per minute 2/Acute respiratory deterioration requiring medical review 3/Suspected Deep Vein thrombosis or Pulmonary Embolism awaiting investigation / treatment
4/ Clinically significant pneumothorax or pleural effusion awaiting drainage 5/Unstable or unsecured airway
6/Recent tracheostomy insertion (wait until next calendar day) 7/Immediately before or after extubation (1 hour)
8/Presence of acute stridor

Cardiovascular: 1/Presence of Intra Aortic Balloon Pump (IABP) 2/New onset arrhythmia 3/New onset haemodynamic compromise 4/Acute myocardial infarction within 24 hours 5/Floated pulmonary artery catheter in situ 6/Vaso-active infusions (Noradrenaline infusion > 10 mcg/min, Dobutamine infusion >5 mcg/kg/min, Adrenaline >5 mcg/min, Any Vasopressin)

Prescribed Bed Rest: 1/ Spinal fractures / spinal precautions
2/Orthopaedic fractures (eg pelvis), 3/Post-op orders 4/Blunt abdominal trauma e.g. liver laceration, conservative management of splenic laceration (requires medical clearance)

Other: 1/Currently paralysed with muscle relaxants, or requiring ongoing muscle relaxants 2/Awaiting medical or surgical intervention to stabilise medical condition
3/Suspected active bleeding, Hb <70g/L, platelet count <20/microlitres unless cleared by ICU medical team 4/Likely imminent palliation

PRECAUTIONS TO CONSIDER:
Renal: 1/ Continuous Renal Replacement Therapy (CRRT)
2/ Femoral location for vascular access, 3/Active mobilisation contraindicated 4/ Passive mobilisation (sling transfer) ok if central location for vascular access

Nursing staff and Physiotherapist education and training will be conducted over one month between Phases i and ii. Education will be delivered to physiotherapy staff in a 1 hour in-service. Teaching and training will be conducted as per current physiotherapy department competency based assesment processes. Nursing education will be conducted in education sessions in the ICU Interprofessional Program. Training in mobilisation will be conducted as per current unit practices.

iii. Nurse Led Sedation Phase
Enrolled patients will be studied for five months following the introduction of a nurse led sedation protocol for impact on mobilisation targets.

This protocol uses structured targets and recommended medications for the management of analgesia, sedation and delirium using the numerical pain scale, the Richmond Agitation and Sedation Scale (RASS) and the Confusion Assessment Method for ICU (CAM-ICU). Current practice in the ICU adresses sedation and analgesia on an individual paitent basis.

Nursing staff education and training will be conducted over one month between Phases ii and iii. Nursing education and traing will be conducted in multiple education sessions in the ICU Interprofessional Education Program and individual education at the bedside.

Data will be collect on reaching mobilisation, analgesia, sedation and delirium targets.
Intervention code [1] 287167 0
Treatment: Other
Intervention code [2] 287168 0
Rehabilitation
Comparator / control treatment
Treatment (as per the sedation and mobilisation protocols) will be compared to baseline activity and sedation data (i.e. usual practice) measured in the first phase of the study.]
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289597 0
Primary Outcome 1: Functional activity levels measured using the Acute Care Index of Function tool.
Timepoint [1] 289597 0
1) ICU discharge and 2) hospital discharge
Secondary outcome [1] 302802 0
Secondary Outcome 1: Sedation levels measured using the Richmond Agitation Sedation Scale (RASS) tool.
Timepoint [1] 302802 0
4-hourly during ICU admission until discharged from ICU.
Secondary outcome [2] 302803 0
Secondary Outcome 2: Presence of delirium measured using the Confusion Assessment Method (CAM-ICU) tool.
Timepoint [2] 302803 0
Daily during ICU admission until discharged from ICU.
Secondary outcome [3] 302804 0
Secondary Outcome 3: Quality of life measured using the EQ5D tool.
Timepoint [3] 302804 0
Hospital discharge and 12 months follow-up.
Secondary outcome [4] 302805 0
Secondary Outcome 4: Achieving or suceeding mobilisation targets
Timepoint [4] 302805 0
Daily during ICU admission until discharged from ICU.
Secondary outcome [5] 302806 0
Secondary Outcome 5: Duration of mechanical ventilation measured as total days and number of ventilator- free days per month.
Timepoint [5] 302806 0
1) on discharge from ICU.
Secondary outcome [6] 302807 0
Secondary Outcome 6: Length of stay (ICU and total hospital)
Timepoint [6] 302807 0
1) on discharge from ICU and 2) on discharge from hospital.
Secondary outcome [7] 302808 0
Secondary Outcome 7: Survival (mortality)
Timepoint [7] 302808 0
1) on discharge from ICU 2) on discharge from hospital 3) at 12 months follow-up
Secondary outcome [8] 302809 0
Secondary Outcome 8: Discharge destination.
Timepoint [8] 302809 0
Timepoint: on discharge from hospital.
Secondary outcome [9] 302810 0
Secondary Outcome 9: Number of hospital readmissions after hospital discharge
Timepoint [9] 302810 0
At 12 months follow-up via phone interview
Secondary outcome [10] 302811 0
Secondary Outcome 10: occurrence of adverse events with mobilisation

Management of adverse events:
The following criteria would cause the treating therapist to cease therapist to cease mobilisation, return patient to chair or bed and alert on-site medical attention.
1/ Detachment of lines, 2/ Fall, 3/Detachment of ventilator equipment
4/ Extubation or decannulation 5/ Increasing ventilatory or vasopressor support in response to: *Alteration in blood pressure > or < 20% of resting, SBP < 90 mmHg or > 200 mmHg, *Alteration in heart rate < or > 20% of resting, *New arrhythmia, *Oxygen desaturation >10% or SpO2 <85%, unless altered by medical staff on an individual basis for patients with baselines severe chronic respiratory failure.
5/ Suspected pneumothorax, 6/Agitation/delirium severe enough to make the patient a danger to themselves and/or requiring increased sedation.
Timepoint [10] 302811 0
For each mobilisation episode

Eligibility
Key inclusion criteria
All adult (age greater or equal to 16 years) patients admitted to the Canberra Hospital ICU within the time period for each phase predicted to be mechanically ventilated for more than 2 calendar days on intensive care admission.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1/ Patients unable to mobilise prior to ICU admission, for example patient who are wheelchair bound or high level care nursing home patients
2/ Patients transferred from another ICU who were mechanically ventilated > 48 hours prior transfer
3/ Failure to obtain consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects who meet the inclusion criteria will be invited to participate in the study by the chief investigator (or delegated physiotherapist). Delayed informed consent from all patients or their next of kin may be necessary in this critically ill patient group who may not be awake enough to provide informed consent at the time of inclusion in the study. Patients will sign their own consent forms or if unable to do so, next of kin will sign the consent form on their behalf. Consent will be witnessed by the physiotherapist, the next of kin and a third person unrelated to the study. Information sheets will also be provided to the patients and families.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Prospective, single centre before and after intervention design
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be presented using means, standard deviations, medians and inter-quartile ranges, counts and percentages as appropriate. Comparisons of frequencies or rates will be performed using Poisson regression models. Hospital length of stay between the three periods will be compared using a log rank test. The relationship between functional status at hospital discharge, the two interventions and other variables will be determined using a multiple logistic regression analysis model using functional status as the response variable. Patients who die will be censored at the time of death. All analyses will use two-sided p-values. Data will be analysed a priori for the impact of a neurological diagnosis, chronic substance abuse and pre-existing co-morbidities likely to limit mobility.

Sample size justification:
Based on recent local pilot data, which assessed the ACIF at hospital discharge in a similar sample of ventilated critically ill patients, 45 subjects in each group will provide a power in excess of 90% to detect a 20% difference between groups with alpha of 0.05. This assumes a within groups standard deviation of 0.29, and provides a difference that would be clinically meaningful. A minimum sample size of 60 subjects in each group allows for patient drop out. Review of unit data for patients requiring mechanical ventilation for more than 48 hours reveals a mortality rate of approximately 20%. Currently the ICU admits over 250 patients per year who are mechanically ventilated for two days or more. Even if only 50% of patients are enrolled, the study will meet the above power requirements.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/02/2013
Actual
18/02/2013
Date of last participant enrolment
Anticipated
18/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
135
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 1013 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 6886 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 287293 0
Hospital
Name [1] 287293 0
Allied Health Advisors Office
Canberra Hospital
Country [1] 287293 0
Australia
Primary sponsor type
Individual
Name
Margot Green
Address
Physiotherapy Department
Canberra Hospital
Yamba Drive Garran ACT 2605
Country
Australia
Secondary sponsor category [1] 286047 0
Individual
Name [1] 286047 0
Dr I Anne Leditschke
Address [1] 286047 0
Intensive Care Unit
Yamba Drive
Canberra Hospital
Garran, ACT 2605
Country [1] 286047 0
Australia
Other collaborator category [1] 277405 0
Individual
Name [1] 277405 0
Dr Sean Chan
Address [1] 277405 0
Intensive Care Unit
Yamba Drive
Canberra Hospital
Garran, ACT, 2605
Country [1] 277405 0
Australia
Other collaborator category [2] 277406 0
Individual
Name [2] 277406 0
Bernie Bissett
Address [2] 277406 0
Physiotherapy Department
Canberra Hospital
Yamba Dr,
Garran ACT 2605
Country [2] 277406 0
Australia
Other collaborator category [3] 277407 0
Individual
Name [3] 277407 0
Associate Professor Imogen Mitchell
Address [3] 277407 0
Intensive Care Unit
Canberra Hospital
Yamba Dr
Garran ACT 2605
Country [3] 277407 0
Australia
Other collaborator category [4] 277408 0
Individual
Name [4] 277408 0
Dr Manoj Singh
Address [4] 277408 0
Intensive Care Unit
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country [4] 277408 0
Australia
Other collaborator category [5] 277409 0
Individual
Name [5] 277409 0
Dr Teresa Neeman
Address [5] 277409 0
Statistical Consulting Unit
John Dedman Building
Australian National University
Canberra
ACT 2600
Country [5] 277409 0
Australia
Other collaborator category [6] 277410 0
Individual
Name [6] 277410 0
Sarah Latham
Address [6] 277410 0
ANU Medical School
Canberra ACT 2600
Country [6] 277410 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289270 0
ACT Government Health Directorate Human Research Ethics Committee
Ethics committee address [1] 289270 0
Ethics committee country [1] 289270 0
Australia
Date submitted for ethics approval [1] 289270 0
Approval date [1] 289270 0
07/12/2012
Ethics approval number [1] 289270 0
ETH.10.12.237

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40102 0
Miss Margot Green
Address 40102 0
Margot Green
Physiotherapy Department
Canberra Hospital
Yamba Drive, Garran, ACT 2605
Country 40102 0
Australia
Phone 40102 0
+61 2 62442154
Fax 40102 0
Email 40102 0
margot.green@act.gov.au
Contact person for public queries
Name 40103 0
Margot Green
Address 40103 0
Margot Green
Physiotherapy Department
Canberra Hospital
Yamba Drive, Garran, ACT 2605
Country 40103 0
Australia
Phone 40103 0
+61 2 62442154
Fax 40103 0
Email 40103 0
margot.green@act.gov.au
Contact person for scientific queries
Name 40104 0
Margot Green
Address 40104 0
Margot Green
Physiotherapy Department
Canberra Hospital
Yamba Drive, Garran, ACT 2605
Country 40104 0
Australia
Phone 40104 0
+61 2 62442154
Fax 40104 0
Email 40104 0
margot.green@act.gov.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



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