Safety of Protocolized Motorized Verticalization in Critically Ill Patients With Impaired Consciousness and Invasive Devices, Including External Ventricular Drains

Abstract

OBJECTIVES:

Critically ill patients with impaired consciousness and concurrent invasive devices remain understudied in ICU mobilization research. Motorized verticalization enables graded upright weight bearing without requiring active patient participation, but device safety in high-acuity neurocritical care populations is not well characterized. We evaluated the safety of a protocolized motorized verticalization program with invasive device dislodgement as the primary outcome.

DESIGN:

Single-center retrospective cohort study.

SETTING:

Neurocritical care unit at a Level 1 trauma and comprehensive stroke center.

PATIENTS:

Adults receiving motorized verticalization therapy between October 1, 2024, and October 1, 2025, according to the institutional protocol.

INTERVENTIONS:

Protocolized motorized verticalization therapy using a graded upright weight-bearing approach with the VitalGo Total Lift Bed, beginning at 10° and progressing incrementally based on physiologic tolerance. Sessions occurred three to four times daily with individualized duration and angle advancement. Angle intensity was categorized as low (< 30°), moderate (30°–45°), or high (> 45°).

MEASUREMENTS AND MAIN RESULTS:

Thirty-three patients underwent 153 treatment sessions comprising 409 verticalization angle exposures. The cohort was high acuity (mean Glasgow Coma Scale 8 ± 3); 90.9% were intubated, 93.9% had central venous catheters (CVCs), and 36.4% had concurrent endotracheal tubes (ETTs), CVCs, and external ventricular drains (EVDs) . No device dislodgements occurred across any session or exposure, and no session termination due to ICP crisis or hemodynamic instability. Applying the rule-of-three statistical analysis, using angle exposures as the event opportunity denominator, the upper bound adverse event risk was less than 0.7% overall, less than 1.1% for moderate angles, and less than 2% for EVD-associated exposure. Most exposures (65.2%) occurred at moderate angles, totaling 14,443 minutes. A subset of EVD patients tolerated angles greater than 45°, including up to 75°.

CONCLUSIONS:

Protocolized motorized verticalization therapy was implemented without observed ETT, CVC, or EVD dislodgement in this high-acuity cohort. Findings support further multicenter evaluation of motorized verticalization effects on device safety, physiologic tolerance, neurologic recovery, and patient-centered outcomes.

KEY POINTS.

Question: Can protocolized motorized verticalization be performed in critically ill patients with impaired consciousness and invasive devices without device dislodgement?

Findings: In 33 patients undergoing 153 sessions and 409 angle exposures, no ETT, CVC, or EVD dislodgements were observed, including among patients with EVDs exposed to higher verticalization angles.

Meanings: These findings provide preliminary safety data supporting prospective multicenter evaluation of motorized verticalization in high-acuity neurocritical care populations.

Patients with impaired consciousness and substantial invasive device burden remain understudied in ICU mobilization research. In neurocritical care, concerns for device displacement, physiologic intolerance, and management of external ventricular drains (EVDs) may limit progression beyond conventional repositioning or head of bed elevation (1, 2). Mobilization is recommended in critical care and endorsed by current clinical practice guidelines to mitigate immobility-related complications such as ICU-acquired weakness, muscle atrophy, and functional decline (3, 4). Critically ill patients, particularly those with neurologic injury, may lose 2–3% of skeletal muscle mass per day during immobilization, underscoring the urgency of weight-bearing interventions (5–7). Yet, guideline recommendations and real-world practice remain misaligned in neurocritical care, where hemodynamic instability, impaired consciousness, and invasive device burden create barriers that standard mobility protocols cannot overcome. A conventional mobility approach is challenging when patients cannot follow commands or actively participate (8, 9). Motorized verticalization offers a different approach by providing graded upright positioning and lower extremity weight bearing without requiring active patient participation (10, 11). Motorized verticalization may therefore provide a structured means of delivering upright positioning while maintaining continuous physiologic and device monitoring (12). Published experience with verticalization in patients with severe acquired brain injury supports the feasibility of this approach, but safety data in patients with impaired consciousness and concurrent invasive neuromonitoring devices remain limited (13). Prior reports of mobilization in patients with EVDs have demonstrated feasibility under structured protocols, but much of the literature has focused on patients able to participate in conventional mobility activities (14–16). The safety of repeated motorized verticalization exposures in patients with impaired consciousness and substantial concurrent device burden therefore warrants direct evaluation.

This study aimed to evaluate the safety of protocolized motorized verticalization therapy in neurocritical care patients with impaired consciousness and high invasive device burden, with endotracheal tube (ETT), central venous catheter (CVC), or EVD dislodgement as the primary outcome.

MATERIALS AND METHODS

Study Design and Participants

This single-center retrospective cohort study was conducted in the neurocritical care unit of a large community teaching hospital, a Level 1 trauma center, and a comprehensive stroke center in Georgia, United States. The study was conducted in accordance with ethical standards and was approved and deemed exempt by the Brenau University Review Board (#2398283-1). This report adheres to the Strengthening the Reporting of Observational Studies in Epidemiology guidelines for observational studies.

All adult patients (≥ 18 yr) admitted to the neurocritical care unit between October 1, 2024, and October 1, 2025, with active orders for motorized verticalization therapy and who met eligibility criteria per the institutional protocol were included. Eligibility criteria, relative contraindications, prescribed frequency, angle and duration options, and protocol-defined physiologic monitoring thresholds are summarized in Table 1. The study window was limited to the first year following protocol maturation, completion of standardized nursing education and competency validation, and adoption of uniform documentation practices. Nursing staff completed structured competency training covering equipment operation, physiologic monitoring thresholds, EVD management, and recognition of intolerance.

TABLE 1.

Motorized Verticalization Bed Therapy Protocol

Exclusion criteria	Hospice consulted Contraindications for verticalization therapy (relative contraindications—these may be approved at provider discretion) Weight limit of total lift bed, 425 pounds Height limit of bed, 6 ft 7 inch. Unstable lower limb, pelvis and spinal fractures with non–weight-bearing orders, traction Active angina and/or cardiac ischemia Hemodynamic instability refractory to inotropic/vasoactive support at rest Acute life-threatening arrhythmias Unsecured airway/unstable life-threatening airway RASS +3 to +4
Frequency	□ 3 × daily□ 4 × daily
Angle	□ 10°□15°□ 20°□ 30°□ 45° □ Other
Time	□ 5 min□ 10 min□ 15 min□ 20 min□ 30 min
Nursing instructions	Notify physician if MAP > 130 mm Hg MAP < 55 mm Hg HR > 150 beats/min HR < 50 beats/min Respiratory rate > 45 beats/min Spo2 < 95 (Neuro ICU), < 88 (other ICUs) If patient unable to complete therapy for three consecutive trials, consider discontinuation Obtain baseline vital signs Assess for signs of intolerance with every angle change Assess vital signs every 5 min during therapy Obtain peak angle vital signs Obtain posttherapy vital signs

HR = heart rate, MAP = mean arterial pressure, RASS = Richmond Agitation Sedation Scale.

Patient selection and initiation of verticalization therapy were determined by multidisciplinary clinical consensus after protocol eligibility and clinical readiness were established. Six motorized verticalization beds were available during the study period and were allocated on a rotating basis. Priority was generally given to patients expected to require prolonged neurocritical care, those with severe neurologic injury or impaired consciousness, and those with invasive device burden limiting conventional mobility. Patients with protocol-defined contraindications were excluded. No additional fixed time to the first session criterion was used beyond protocol eligibility, clinical readiness, and bed availability.

Artificial intelligence (AI)-assisted tools were used solely for grammar, punctuation, and reduction of redundancy within the article. No AI tools were used to generate scientific content, interpret data, or influence study design or conclusions. All content was reviewed and approved by the authors, who take full responsibility for the article.

Interventions

Eligibility for motorized verticalization therapy was assessed by the neurocritical care and rehabilitation teams. Initial treatment sessions were multidisciplinary and typically involved physical therapy and occupational therapy with bedside nursing; a neurocritical care physician or advanced practice provider participated when clinically indicated. Subsequent treatment sessions were performed by the nursing staff with provider participation based on clinical circumstances. The number and composition of personnel therefore varied according to the phase of treatment, patient acuity, invasive device burden, and clinical needs. During selected sessions, additional nonprocedural sensory input could be provided by family members or members of the supportive care team, including music-based engagement or chaplain-led prayer as part of routine individualized care. Before each session, invasive lines and devices were secured. For patients with EVDs, drains were clamped before positioning and re-leveled after each angle adjustment, and ICP was monitored before, during, and after therapy according to the institutional protocol. When an arterial catheter was present, its pressure transducer was re-leveled at angles of 30° or greater.

Motorized verticalization therapy was performed using the VitalGo Total Lift Bed (17) (Fig. 1) according to the institutional protocol (Table 1). Sessions began at 10° and progressed incrementally according to physiologic tolerance. The protocol prescribed treatment sessions were performed three to four times daily, with session duration and angle progression individualized within protocol limits. Angle intensity was categorized as low (< 30°), moderate (30°–45°), or high (> 45°). Exposure time was defined as the duration in minutes that each documented verticalization angle was maintained.

Figure 1.

The VitalGo Total Lift Bed is used for motorized verticalization therapy. The system enables progressive transition from supine to upright standing posture with graded weight-bearing through the lower extremities. The total lift mechanism redistributes gravitational load from the sacrum and posterior pelvis to the plantar surface, supporting simultaneous pressure relief and multimodal sensory stimulation in patients unable to participate in active rehabilitation.

Outcome Measures

The primary outcome was device dislodgement (ETT, CVC, or EVD) during or immediately after therapy. Secondary outcomes included session duration and tolerated angle intensity. Categorical variables were summarized as counts and percentages; continuous variables as mean ± sd or median (interquartile range [IQR]). No formal hypothesis testing was performed given the descriptive nature of this safety study. Adverse event rate upper bounds were estimated using the rule-of-three statistical method. Angle exposure was selected as the predefined event opportunity denominator because each discrete angle transition or maintained verticalization exposure may introduce an opportunity for device displacement or EVD leveling error. Exposure level estimates were interpreted descriptively because repeated exposures were clustered within patients.

Verticalization sessions and discrete angle exposures were retrospectively abstracted from structured nursing and rehabilitation documentation. Standardized session documentation captured pretreatment and posttreatment physiologic parameters, each verticalization angle achieved, duration at each angle, and documented patient tolerance. A representative blank, de-identified verticalization documentation template is provided as Supplemental Figure 1 (https://links.lww.com/CCX/B689). Each documented angle maintained during a session was counted as one discrete angle exposure for exposure level analysis.

RESULTS

Thirty-three patients met inclusion criteria. The mean age was 59 ± 14.6 years, 48.5% were male, and mean body mass index was 28 ± 6.5. Hemorrhagic stroke was the most common admission diagnosis (54.4%). This cohort had a mean Glasgow Coma Scale (GCS) of 8 ± 3, and 90.9% were mechanically ventilated. More than one-third of patients (36.4%) had simultaneous ETT, CVC, and EVD. Baseline characteristics are presented in Table 2. Median time to therapy initiation was 9 days (IQR, 6–12 d).

TABLE 2.

Baseline Characteristics

Variable	N = 33
Age (yr), mean ± sd	59 ± 14.6
Sex (male), n (%)	16 (48.5)
Race n (%)
Black or African American	4 (12.1)
White	24 (72.8)
Multi-racial	5 (15.1)
Ethnicity n (%)
Hispanic or Latino	4 (12.1)
Not Hispanic or Latino	29 (87.9)
Body mass index, mean ± sd	28 ± 6.5
Admission diagnosis, n (%)
Hemorrhagic stroke	18 (54.4)
Ischemic stroke	5 (15.2)
Neuromuscular diseases	5 (15.2)
Other	5 (15.2)
Invasive device, mean ± sd
Endotracheal tube	30 (90.9)
Central venous catheter	31 (93.9)
External ventricular drain	12 (36.4)
All three lines	12 (36.4)
Time to therapy initiation, d, median (interquartile range)	9 (6–12)

Results are presented as mean ± sd, median and interquartile range and number and percentage as appropriate.

A total of 153 verticalization sessions comprising 409 discrete angle exposures were analyzed, representing a mean of 4.6 sessions and 12.4 angle exposures per patient (409/33 = 12.39, rounded to 12.4). Across all sessions and exposures, no ETT, CVC, or EVD dislodgements or unplanned extubations occurred. Applying the rule-of-three with angle-specific exposure counts, the upper bound for adverse event risk remained below 0.7% overall, 1.1% for moderate angle exposures, and 2% for EVD-associated exposures. Because exposures were repeated within patients, these bounds serve as descriptive estimates rather than formal inferential limits, contextualized by the substantial cumulative verticalization time (14,443 min). No session termination due to the ICP crisis occurred. In available nursing and rehabilitation documentation, no session termination attributable to hemodynamic instability or acute clinical deterioration was identified in temporal association with verticalization therapy, including in the EVD subgroup. Exposure distribution by angle intensity is shown in Figure 2. Most exposures (65.2%) occurred at moderate intensity, followed by low intensity (31.3%) and high intensity (3.3%). Median session duration was 30 minutes (IQR, 23–30 min). Total cumulative verticalization time was 14,443 minutes (240.7 hr), with a mean of 438 minutes per patient. Cumulative time was greatest at moderate angles (13,170 min) compared with low (900 min) and high angles (373 min), as shown in Figure 3.

Figure 2.

Distribution of verticalization exposures (n = 409) by angle intensity category: low (< 30°), moderate (30–45°), and high (> 45°). Most exposures occurred at moderate intensity (65.2%), with no device dislodgements observed at any angle category.

Figure 3.

Cumulative duration of verticalization therapy (minutes) by angle intensity category. Moderate angles (30–45°) accounted for the greatest cumulative exposure time (13,170 min). A subset of EVD patients tolerated high-angle positioning (> 45°) up to 75° without intracranial or device-related complications, representing 373 cumulative minutes of high-intensity verticalization.

DISCUSSION

In this single-center retrospective cohort, protocolized motorized verticalization was implemented without observed ETT, CVC, or EVD dislodgement across 409 discrete angle exposures in 33 critically ill patients with impaired consciousness and substantial invasive device burden. The zero-event result provides a preliminary safety signal in a population for whom conventional mobility may be difficult to implement and supports further prospective evaluation rather than establishing definitive safety. These findings should be interpreted in the context of an evolving literature. Previous studies have demonstrated that mobilization can be performed in selected patients with EVDs under structured protocols (14–16). More recent studies by Jia et al (18) evaluated passive upright positioning with a motorized standing bed in neurocritically ill patients, including patients with impaired consciousness. One prospective-retrospective controlled study reported improvement in neurologic measures during a program of passive verticalization. A subsequent pilot cohort study focused on feasibility and safety with documented adverse events, including EVD dislodgement (19). These reports support continued investigation of verticalization while underscoring that device complications remain possible and that standardized device management and monitoring are essential. Our cohort differs in its repeated exposure level characterization and in the use of a protocol emphasizing device security, EVD clamping and releveling, and physiologic monitoring at each stage. The absence of observed device dislodgement does not imply zero risk; rather, the rule-of-three upper bounds provides a transparent estimate of the risk compatible with a zero-event sample. Because exposures were repeated within patients, these exposure level bounds should be interpreted descriptively. The EVD subgroup is clinically relevant because upright positioning requires careful management of drainage reference level and intracranial pressure (ICP). Patients with EVDs in this cohort underwent graded positioning, including a subset above 45° and up to 75°, without observed EVD dislodgement or ICP crisis. These observations support the feasibility of a structured approach in appropriately selected patients but should not be generalized beyond the protocol, staffing, monitoring, and institutional experience represented in this cohort.

While this study was conducted in a neurocritical care unit, impaired consciousness, invasive device burden, and the inability to participate in active rehabilitation are not unique to primary neurologic injuries. These features characterize a substantial proportion of patients across medical, surgical, and trauma ICUs, including those with severe sepsis-associated encephalopathy, anoxic brain injury, refractory hemodynamic instability, and postoperative states, making the safety question addressed here relevant to any critical care setting in which this population is encountered (20–23).

This study has limitations inherent to its retrospective design. Documentation variability may have underestimated the true number of exposures, particularly at higher angles. The sample size was small and derived from a single institution with an established mobility culture and six motorized verticalization beds, which may limit generalizability. Selection for therapy reflected protocol eligibility, multidisciplinary clinical judgement, clinical readiness, and bed availability, introducing potential selection bias. The absence of a control group and efficacy outcomes reflects the study’s design as a safety cohort. The median 9 days to first session reflects real-world implementation and should not be interpreted as an optimal initiation time. Prospective studies should include time-to-first-verticalization as a primary implementation metric.

Recovery of consciousness and arousal were not evaluated in this safety study and therefore are not presented as outcomes. Prior verticalization studies have reported changes in measures of consciousness or neurologic function, including GCS and Coma Recovery Scale-Revised (10, 13). Future prospective studies should evaluate these outcomes using validated longitudinal measures and determine whether graded upright positioning, with or without structured multimodal sensory stimulation, contributes to arousal or recovery. Although not systematically measured as an outcome, we would like to note that bedside staff and family members observed apparent increases in arousal and interaction during some verticalization sessions. This hypothesis-generating observation is consistent with a recent report of improved consciousness measures during verticalization and warrants prospective evaluation (18).

Future research should progress through prospective multicenter observational studies and registry-based data collection to characterize implementation, device safety, physiologic tolerance, and uncommon adverse events across diverse institutions. Once safety is further established, adequately powered prospective trials should evaluate validated measures of consciousness and arousal, including the potential role of verticalization as a platform for structured multimodal sensory or coma stimulation, together with pulmonary, orthostatic, muscle preservation, functional, and patient-centered outcomes.

CONCLUSIONS

Protocolized motorized verticalization therapy was implemented without observed ETT, CVC, or EVD dislodgement across 409° angle exposures in this single-center cohort of critically ill patients with impaired consciousness and substantial invasive device burden. The exposure level rule-of-three upper bound for device displacement risk was below 0.7% overall. These findings provide preliminary safety data supporting prospective multicenter investigation. Future studies should prospectively assess physiologic tolerance and patient-centered outcomes, including consciousness, pulmonary function, muscle preservation, and functional recovery.

ACKNOWLEDGMENTS

We thank the neurocritical care unit nursing staff and rehabilitation teams for their contributions to patient care and protocol implementation.

Supplementary Material

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