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Three Part Question

Are [patients post SAH with EVD] able to [commence early mobilisation with an EVD clamped] without [experiencing adverse events]?

Clinical Scenario

A Physiotherapist would like to know if the benefits of participation in early mobilisation with patients post SAH with EVD outweigh the risks of adverse events relating to EVD and mobilisation

Search Strategy

AMED (1)
CINAHL (2)
EMBASE (19)
MEDLINE (10)

Date range used (5 years, 10 years): -
Limits used (gender, article/study type, etc.): English language
Search terms and notes (full search strategy for database searches below):
Medline, Embase, CINAHL and AMED via HDAS, and Cochrane CENTRAL and CDSR, were searched with the concepts of EVD AND mobilisation, in free text and thesaurus terms. EVD is also an acronym for Ebola Virus Disease, so results with "ebola" in the title or abstract were excluded.
PEDRO was searched for synonyms of EVD, with no results.

Search Outcome

34 studies were identified, 23 were inappropriate to the clinical question, duplicates or letter to the editor in response to a published study. Of the remaining 11, 4 again were duplicates of a Quality Improvement project /discussion and therefore omitted.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Bethany Young, Megan Moyer, William Pino, David Kung, Eric Zager & Monisha A. Kumar 18th Jan 2019 USA	Acute admission of SAH onto ITU post EVD insertion The primary outcome measure was frequency of patient mobilisation. Safety outcomes included elevation of ICP, acute onset of headache during mobilisation, and acute focal/worsening of neurologic deficits. Secondary outcomes included ICU and hospital length of stay, rates of tracheostomy and ventriculoperitoneal shunt placement, discharge disposition, and ventilator days. PHASE 0: Patients diagnosed with SAH admitted to Neuro ICU from 2013 to 2014 were retrospectively identified via query of Electronic Medical Record (EMR). [Exclusion: comfort measures or hospice care not included]. Result: No mobilisation took place while an EVD was in place. No PT/OT consulted until after drain removed with an order of strict bed rest until that time. Phase 1: Subjects for Phases I and II were prospectively identified from an IRB-approved cohort of SAH patients admitted to the Neuro ICU between 2014 and 2016. Phase 1 lasted 12 months from 2014 to 2015 and characterised by PT/OT driven protocol. Mobilisation occurred only during formal PT/OT sessions with continuous presence of both the therapist and the bedside nurse. Activities included sitting at the edge of the bed, standing in place, and marching in place. No independent time out-of-bed occurred in Phase I. Phase 2: Began from Jan 2016 for 8 months and defined by a Nurse Driven Protocol and could occur prior to initial PT/OT evaluation. Patients were permitted to remain out of bed in a chair with drain clamped for up to 3hrs at a time with the drain clamped for the entirety of the mobilisation session in order to prevent over drainage of CSF and vital signs assessed Hourly. Intensity and duration of activity and time out of bed was subject to patient preference/tolerance and nursing workflow.	Phase 0: Retrospective review Phase 1/2: Cross sectional Study Design	Frequency of patient mobilisation:	Phase 0: No patients (n =15) in the phase were mobilised with an EVD. Phase 1 (n = 24), first mobilisation occurred 14 days earlier (hospital day 6 vs hospital day 20, p < 0.0001) with implementation of the therapy driven protocol. A total of 71 mobilisation sessions were completed for the 24 patients in Phase 1, all of which were completed by PT/OT and nurses to focus on transition from lie to sit/step transfer to chair. Phase 2 (n =17), mobilistion occurred on average 1 day earlier than with the therapy driven protol. Patient were mobilised more frequently with each iteration of the trial, from complete bed rest in Phase O to an avergae of 3 mobilisation sessions per ICE stay in Phase 1 (p < 0.0001) and 7 sessions per ICU stay in Phase II (p < 0.0001)	This is a quality improvement initiative in a single Neuro ICU, restricting analysis to a specific patient population = Small sample size and power lacking to establish a veritable effect on outcomes. Data regarding duration of mobilisation sessions, employed mobilisation manoeuvres and functional milestones recorded inconsistently. Assessor Bias Data collection for Phase 0 occurred retrospectively. Nil assessor blinding.
			Safety Outcomes (Elevation of ICP, acute onsent of headache during session and acute focal/worsening of neurological deficits	Phase 1: 23 instances where PT/OT consultation was intended but no mobilisation actually occurred. Reasons included: acute worsening of neurologic examination, hyper- or hypotension, and increased ICP. 4 sessions were aborted mid session due to pain/increased ICP, and hypotension. Phase 2: 11 attempted but never initiated mobilisation sessions, reasons for withholding included: traveling for testing or procedures, hypertension, increased ICP, and symptomatic vasospasm. Only one session was aborted mid-session due to elevated ICP. Overall, No falls, incidental medical device dislodgement (central venous catheters, arterial lines, endotracheal tubes, enteric feeding tubes, indwelling urinary catheters), acute hypoxia, new onset arrhythmias, prolonged elevated ICP, or neurologic changes occurred in association with early mobilisation throughout the duration of data collection for our quality improvement initiative. Nil EVD dislodgement occurred as a result of mobilisation or directly related to mobilisation.
			Secondary Outcomes (ICU and hospital length of stay, rates of tracheostomy and ventriculoperitoneal shunt placement, discharge disposition, and ventilator days) :	In a multivariate analysis, the odds of discharge to home or rehab versus LTACH or SNF were 3.83 (95% confidence interval, 1.14–9.16) for mobilized patients, independent of age, Glasgow Coma score (GCS) at first mobility session, and high HH grade (Table 3). Mobilization of patients was not significantly independently associated with hospital length of stay, tracheostomy placement, or ventilator days.
Moyer, Megan; Young, Bethany; Wilensky, Eileen Maloney; Borst, Joseph; Pino, William; Hart, Marisa; April 2017 Canada	Patients were recruited from the neuro-ICU at an academic medical center. Patients with SAH with EVDs (n = 26) were prospectively enrolled for the 12 months after implementation of the EVD mobility algorithm and compared with an age- and sex- matched historical control group from the 12 months before algorithm adoption (n = 19). Patients who were placed on comfort care measures and/or hospice were excluded. Individuals requiring mechanical ventilation were not excluded. Demographics between the control and intervention groups were not statistically different. - Seventeen women (90%) were in the control group, whereas 22 (85%) were in the intervention group. - Mean age was 59.6 years for the control group and 55.7 years for the intervention group. Four patients in both the control group (21%) and the intervention group (15%) had a Hunt and Hess grade of 4 to 5. Seventeen patients in the control group (90%) and 26 patients in the intervention group (100%) had a Fisher grade of 3 or higher. At the time of first mobilisation, 7 patients in both the control group (36.8%) and the intervention group (26.9%) had a Glasgow Coma Scale score of less than 13. Richmond Agitation Sedation Score at the first mobilisation was -1 to +1 in 16 of the control group patients (84%) and 23 of the intervention group patients (88%). During the Intervention phase, daily comprehensive, interdisciplinary patient screening resulted in earlier entry of PT/OT consult orders and significantly decreased the mean length of time to the first mobilisation from 18.7 to 6.5 days (PG .0001). In the intervention group, drains remained in place for a mean of 15 days, compared with 16.3 days in the control group (P = .422).	Cohort Study consisting of Prospective interventional design and retrospective control group , observational study.	Frequency of patient mobilisation:	From December 2014 to December 2015, 26 patients with SAH with an EVD were mobilised according to the pathway. These were compared with 19 patients with SAH with an EVD from the previous 12 months who, according to department policy, were confined to strict bed rest for the duration of time that their drain was in place For the 12 months after the implementation of the mobility algorithm, 101 activity sessions were attempted in the neuro-ICU with patients with SAH. Of these attempts, 24 sessions were withheld for reasons including worsening neurologic examination (10), pulmonary instability (2), hemodynamic instability (2), provider request (1), or other conditions of medical instability (3). Six sessions were initiated but aborted mid-session for increased lethargy (1), pain (1), elevated ICP (1), drain malfunction (1), and hypotension (2). On average, patients were mobilized 3 times (1Y5) while their EVD was in place. The mean length of a single therapy session was 32 (20Y55) minutes. Day of 1st mobilisation within the Control group (18.7 days) compared to phase 1 intervention 6.5 days (P < 0.0001)	Assessor bias/ not blinded - intervention group were undergoing/experience implementation pathway of early mobilisation therefore inherent bias. Single centre study
Rebekah A. Yataco, Scott M. Arnold, Suzanne M. Brown, W. David Freeman, C. Carmen Cononie, Michael G 24th October 2018 USA	Retrospective electronic health record review to include all patients in the neurosurgical ITU who underwent placement of an EVD between Jan 2013 to May 2016 at the Mayo Clinic in Jacksonville, Florida. Inclusion criteria: patients deemed haemodynamically and medically/neurosurgically stable by the treating NSICU team. They were then considered for early functional mobilisation by OT/PT and able to actively engage in evaluation and treatment session. Exclusion Criteria: Haemodynically unstable, active bleeding, HR > 120 , ICP > 25 , CPP < 50 , Resting HR of 50% age predicted max or less, SBP < 9 or > 180, Diastolic > 105, peripheral O2 < 90% , marked diaphoresis, facial pallor, intense anxiety or painful facial expressions or active bleeding from lines, catheters or wounds.	Single-site, retrospective chart review of 153 patients who underwent placement of an EVD.	OUTCOME	153 patients received EVDs during the 40 Month Time Period. DATA COLLECTION: Mobility events included transfer from supine to sitting on side of the bed, rising from sitting to standing by side of bed, transfer from bed to bedside chair and ambulating any distance away from the bed. Potential adverse events: Unstable ICP (> 20 for more than 2mins), CPP < 50mmHg, SBP <90 or > 180 , Diastolic >105, orthostatic SPB drop of > 20mmHg following positional change , persistent saturation of peripheral O2 < 90%, increased headache, nausea and emesis. Serious Adverse events included EVD dislodgement or removal from the head or an event that leads to serious health detection such as patient collapse, syncope, elevated ICP requiring ITU input or major new neurological deficits and death. [Mobilised] = 117 patients were mobilised with the median time from EVD placement to initial mobilisation in 117 patients were 38hrs (range 4-537) and mean time 83hrs. Among the 36 patients that weren’t mobilised, the most common reason was decreased patient responsiveness.	Recall Bias or misclassification bias, cannot determine causation (only association), need larger sample sizes,
			Level of Mobility Achieved	Progressive functional mobilisation by PT/OT of patients with recently placed EVD can be achieved safely and earlier with a relatively low rate of AEs. The highest level of patient mobility activity achieved by the group was ambulation for 51 patients (43.6%) , supine to sitting for 36 patients (30.8%) , from bed to a chair for 20 patients (17.1%) and from sitting to standing for 10 patients (8.5%).
			Adverse Effects to mobilisation:	[AE] to mobilisation was rare and transient (6.9%, CI 3.5-12.9%) which included diastolic BP > 105 (0.9%, 95% CI 0.2 -4.7%) , increased headaches (0.9%, 95%CI 0.2-4.7%) , Emesis (2.6%, 95% CI 0.9-7.3%), nausea (0.9%, 95%CI 0.2-4.7%) and other AEs (1.7%, 95% CI 0.5-6.0%). No EVD dislodgement occurred during patient mobilisation. Summary: nil Adverse effects however limited evidence. Need strict conditions to be met and close monitoring pre, during and post.
Gaspari, Clara H.; Lafayette, Sabrina; Jaccoud, Anna Carolina; Kurtz, Pedro; Lavradas, Luiz A. Jr; C October 2018 Brazil	Purpose:To review the occurrence of adverse events related to Out of beD mobilisation in patients with EVDs. The single centre mobility protocol states that each patient is screened daily to identify any contraindications to mobility during medical rounds with interdisciplinary team (neurointensivists, neurosurgeons, physical therapists and nurses). The contraindications include acute myocardial infarction, active bleeding, unstable seizure activity within 24hrs, ICP 20mmHg or more, agitation (RASS > +2) or MCA mean flow velocity < 120cm/s), heamodynamic instability or the use of any vassopressor medication.	Retrospective Study	OUTCOME:	The hospital’s protocol specifies that at least 2 physical therapists must be present during OOB mobilisation in patients who have EVDs or who have multiple lines and catheters, as nursing does not participate in any OOB mobilisation. The policy further delineates once cleared to mobilised, a physical therapist requests the clamping of the EVD, which is performed by either the nursing staff or a resident of the neurosurgical team. During this procedure, the proper fixation of the catheter on the scalp is ensured. Following the clamping of the device, the therapist secures the catheter onto the patient’s shoulder with tape to minimise the movement of the line during the therapy session. Securing the catheter by placing a firm piece of tape on the patient’s shoulder and instituting a triple- check of the EVD system before and after each session, as described earlier, ensured the integrity of the drain during OOB mobilisation.	As per institution policy, patients who are on any dose of vasopressors are not cleared for OOB mobilization, making this set of criteria very specific and possibly somewhat conservative compared with other centers. Small sample size, retrospective, single-center nature of the study. There is an inherent bias of evaluating only those patients who had PT, and the analysis did not adjust for the severity of illness of a given patient Two patients notably had a high number of PT mobilization sessions (47 and 17 OOB treatments). In both cases, the patients were EVD dependent and required prolonged antibiotic treatment for a central nervous system infection prior to the placement of a permanent shunt. This high number of mobilization events from 2 individuals may have skewed the data and should be considered when interpreting the results.
			Frequency of Patient mobilisation:	One hundred two patients underwent EVD placement from October 2014 to November 2016. Nineteen of these patients had medical clearance to perform OOB mobilisation while the EVD was in place. Eighty-three patients did not have medical clearance for OOB mobilisation because they did not meet the institutional criteria for OOB mobilisation. One patient was excluded because the highest level of mobility achieved was sitting on the edge of bed (due to agitation), which did not classify as OOB mobilisation.
			Highest Level of OOB mobility achieved	Eighteen patients performed OOB mobilizations. The highest level of activity tolerated included 3 patients (16.6%) who were able to perform sitting on bedside chair, 5 patients (27.8%) who performed active standing, 3 patients (16.6%) who stood using a tilt table, and 7 patients (38.9%) who ambulated. These 18 patients performed a total of 108 OOB activities while the EVD was in place. In the event that a patient performed more than 1 OOB activity, only the highest level (as described earlier) was taken into account. 10 PT sessions (9.3%) of tilt-table standing, 11 sessions (10.2%) of sitting on bedside chair, 23 sessions (21.3%) of standing, and 64 sessions (59.2%) of walking. The average time between EVD placement and the initial OOB treatment was 4.2 ± 4.3 days.
			Occurrence of Adverse Events	No serious adverse events during or immediately following the treatment sessions were recorded. No observations of CSF leaking, bleeding, or hematoma. No events of line dislodgement/accidental catheter removal or evidence of catheter malfunction occurred. None of the patients developed any new neurologic deficit.
Syed O Shah, Jacqueline Kraft, Nethra Ankam, Paula Bu, Navid Tabibzadeh, Ilya Levin, Amandeep Dolla, 2015 USA	Patients with EVD that were awake, able to follow commands, MAP > 80 and ICP consistently < 20.	Prospective, observational study at one institution (NeuroCritical Care)	OUTCOME	57 patients with a total of 124 patient encounters recorded over a 6-month period. Average time between EVD placement and PT session was 8.7+/- 5.6 days. 87 Encounters out of 124 were at least standing or better with 52 encounters were walking with assistance. Two adverse events recorded (1.6%) however did not result to permanent neurological changes.	Single centre study, assessor bias/ external validity, small sample size, not replicated in multi-centred trials,
			Safety:	2 out of 124 patient encounters resulted in adverse event ( vital signs outside of norm, raised ICP) however nil occurrences of EVD dislodgement.
			Feasibility:	Majority of patient encounters resulted in standing or at minimum out of bed activities to reduce periods of prolonged bed rest.
Stout K. April 2019 Canada	Physical and Occupational Therapist and the number of years/experience needed to mobilise patients in Neuro-intensive Care units with EVDs. If 2 therapists were involved in mobilising the patient, the experience (in years) of the therapist leading the session was recorded.	Retrospective review of prospective quality improvement database	OUTCOME	Date of admission and EVD placement, type of activity, years of experience of the primary therapist, the number of people required to mobilise a patient and any adverse advents were recorded ( vital signs, arrhythmia, changes in ICP and/or dislodging lines. Binary OUTCOMES: OUT of bed vs in bed, high vs low skill level therapy, absence vs presence of adverse event.	Selection bias on our patient population as only patients referred to OT/PT were mobilised and therefore medically stable or motivated to attempt PT/OT. Selection bias or more experienced therapists to more difficult cases Small sample size , nil control group
			Experience vs Mobilisation encounters	90 patients with 185 encounters. Median of 2 encounters per patient. 81% mobilised Out of Bed , 53% mobilised with aid or better. Mixed-models regression, accounting for multiple encounters per patient, showed that years of experience were negatively associated with highest level of activity with beta estimate (95% CI) of -0.097 (-.17 to -0.02) (P= 0.14). Overall, analysis showed that level of therapist experience was independent from binary outcomes (out of bed vs bed exercises or high vs low level skills activities) (P > 0.05).
			Adverse events as a result of mobilisation	2.2% of encounters experienced adverse events however nil changes upon post neurological exam or resulted in significant harm.
			Number of PT/OT therapist required to mobilise patients with EVD	Majority of encounters required 2 professionals for mobilisation (57%) and 95% of encounters required 1 or 2 professionals for mobilisation. Cochrane-Mantel Hansel test showed no evidence of an association between number of people required to mobilise and the highest activity achieved (p= 0.11)
Hale Chelsea 2013 Canada	Responses from 25 physiotherapists currently working in neurosurgical centres across Canada. 56% had < 10years experience and the rest > 10 years.	Quantitative, descriptive, cross-sectional study design using an online questionnaire via survey monkey. Email invitation and questionnaire link distributed in March 2010	OUTCOME:	69% response rate however during the study, reduced to 59%. Of the total 25 useable questionnaires , only 16 were fully completed and 9 partially completed.	Small response rate , small sample size and therefore not representative of practice among several provinces/neurosurgical centres. Descriptive quantitative study, participation/recruitment bias Incomplete surveys result in further reduction in sample size and therefore limited outcomes. Participation bias, those with more confidence/experience in mobilising EVD patients will be more inclined to participate than others that don’t.
			Canadian physiotherapist mobilising patients and intensity level in relation to therapist experience	76% of respondents felt comfortable mobilising patients with EVD and that it was safe to do so. 96% cited clinical experience and safety concerns as guiding practice. 80% ranked ICP as the most important factor and saturation of O2 as the least important to consider before mobilisation. 63% of respondents stated that other health professionals represent a barrier to mobilisation of a patient with an EVD may not always be supported by staff. CONCLUSION: We found that physiotherapist with more experiecnce were more likely to conduct higher level out of bed mobilisation practices when a patient was stable.

Comment(s)

High quality evidence for early mobilisation within ITU setting to reduce hospital LOS and associated with improved mortality rate post discharge from ITU. Encouraging buy in/participation within MDT setting helped create a culture change to encourage early mobilisation for patients with EVD . I.e. Supporting Nursing staff to buy into early mobilisation and encourage patients to be out of bed. Implementing a pathway and ongoing mentorship to junior therapy members will facilitate early mobilisation with reduced adverse events. Implementing a clear Standard of Operation Procedure prompts staff members to monitor vitals and reduce risk of EVD dislodgement during mobilisation practice Any adverse events identified were related to vital signs and none resulted in permanent neurological alterations Best average out of bed mobilisation achieved was step transfer out to a chair Early mobilisation pathway can feasibly be implemented with 1 qualified/trained therapist

Clinical Bottom Line

The current best evidence suggests that a clear algorithm for safe mobilisation, with consent gained by primary medical team and ongoing education/mentorship for junior therapy members will allow patients post SAH with EVD, commence early mobilisation with an EVD clamped without experiencing adverse events.

References

1. Bethany Young, Megan Moyer, William Pino, David Kung, Eric Zager & Monisha A. Kumar Safety and feasibility of Early Mobilisation in patients with Subarachnoid Haemorrhage and External Ventricular Drain Neurocritical Care 31 88-96 (2019) ,
2. Moyer, Megan; Young, Bethany; Wilensky, Eileen Maloney; Borst, Joseph; Pino, William; Hart, Marisa; Implementation of an Early Mobility Pathway in Neurointensive Care Unit Patients With External Ventricular Devices Journal of Neuroscience Nursing 49, 102-107
3. Rebekah A. Yataco, Scott M. Arnold, Suzanne M. Brown, W. David Freeman, C. Carmen Cononie, Michael G. Heckman, Luke W. Partridge, Craig M. Stucky, Laurie N. Mellon, Jennifer L. Birst, Kristien L. Daro Early Progressive Mobilization of Patients with External Ventricular Drains: Safety and Feasibility Neurocritical Care 30 414-420 (2019)
4. Gaspari, Clara H.; Lafayette, Sabrina; Jaccoud, Anna Carolina; Kurtz, Pedro; Lavradas, Luiz A. Jr; Cavalcanti, Daniel D. Safety and Feasibility of Out-of-Bed Mobilisation for patients with External Ventricular Drains in Neurosurgical ITU Journal of Acute Care Physical Therapist
5. Syed O Shah, Jacqueline Kraft, Nethra Ankam, Paula Bu, Navid Tabibzadeh, Ilya Levin, Amandeep Dolla, Rodney Bell, Fred Rincon, Matthew Vibbert, Michelle Ghobrial, Muhammad K Atha Safety and Feasibilty of Early Amulation in patients with External Ventricular Drains: An Observational Study Neurocrit Care Journal
6. Stout K. Early Mobilization of Patients with External Ventricular Drains: Does Therapist Experience Matter? Journal of Acute Care Physical Therapy 10(2):39-45
7. Hale Chelsea Practice patterns of canadian physiotherapists mobilizing patients with external ventricular drains Physiotherapy Canada ;65(4):365-373