RecruitingACTRN12613000611729

Goal – directed Sedation and Mobilisation in Intensive Care (GoSaM)

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?


Sponsor

Margot Green

Enrollment

135 participants

Start Date

Feb 18, 2013

Study Type

Interventional

Conditions

Summary

Sedative medications are commonly used for ICU patients who require a breathing machine (ventilator). Side effects of the ventilator and sedatives include decreased muscle strength resulting in increased time in ICU and hospital, and decreased functioning on discharge. Recent studies suggest early mobilisation of patients while they are on a ventilator leads to better functioning. However, too much sedative medication makes this difficult. This study investigates the effect of protocols for mobilisation and sedatives on function at hospital discharge in intensive care patients expected to need a breathing machine for more than 2 days. Our hypothesis is that the addition of a nurse led targeted sedation protocol to a targeted mobilisation protocol in critically ill mechanically ventilated patients will lead to improvement in functional status at ICU and hospital discharge. The results will help physiotherapists and intensive care doctors improve the way that they use sedation and mobilisation and will be highly relevant internationally.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a structured nurse-led sedation protocol combined with an early mobilisation (movement and exercise) protocol helps ICU patients on breathing machines recover better physical function before leaving the hospital. Patients in the ICU often receive high doses of sedatives that can cause muscle weakness and longer hospital stays. Researchers want to know if reducing sedation in a structured way while getting patients moving earlier leads to better outcomes. You may be eligible if: - You are 16 years or older - You are admitted to the ICU and are expected to be on a mechanical ventilator (breathing machine) for more than 2 days You may NOT be eligible if: - You were unable to walk or move on your own before your current hospital admission - You were transferred from another ICU after already being on a ventilator for more than 48 hours - Consent cannot be obtained Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.

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.


Locations(1)

The Canberra Hospital - Garran

ACT, Australia

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ACTRN12613000611729