Medical advancement in the care of mechanically ventilated patients has led to increased long-term survival rates.1,2 However, survivors of critical illness generally have increased morbidity, including prolonged weakness, delirium, and reduced quality of life.3 Older adults account for 42% to 52% of all intensive care unit (ICU) admissions and 60% of all ICU days.4 Complications are amplified for older and very old adults, leading to an increase in cost of hospitalization, lengthened stay at rehabilitation facilities, and dependency on others for care.5,6 Immobility has been deemed a strong risk factor for many of these issues.3,7
“Early mobilization” has been defined as the initiation of a mobility program when a critically ill, often mechanically ventilated patient is able to participate in rehabilitation, has a stable hemodynamic status, and is receiving acceptable levels of oxygen.2 In contrast to traditional therapies provided for critically ill patients (eg, passive joint range of motion, positioning, and splinting), early mobility programs require the patient's active participation. Early mobilization of critically ill patients involves rehabilitation specialists (ie, physical and occupational therapists) who engage patients meeting established medical safety criteria in mobility activities (eg, exercises in bed, developing sitting tolerance, and walking).8,9 Nurses and respiratory therapists prepare patients for mobility activities through sedation lightening, when appropriate, and pulmonary care procedures, respectively.
A growing body of evidence supports the safety, feasibility, and health benefits of early mobilization for select populations. Recent studies indicate that early mobilization, when coordinated with the interruption of medication sedation, was safe and well-tolerated and resulted in better functional outcomes at hospital discharge, a shorter duration of delirium, and more ventilator-free days when compared with standard care.10–12 However, multiple barriers such as concerns for patient safety and limited understanding of the benefit of early mobilization continue to remain in many ICUs.13 These barriers create challenges for how to best coordinate multidisciplinary efforts to facilitate early mobilization procedures especially in ICUs with limited resources. Furthermore, the potential benefits of early mobilization on financial metrics, functional outcomes, and quality of life in critically ill geriatric patients have yet to be defined.
Whereas the safety and feasibility of employing early mobility procedures for critically ill patients have been documented,8,10–12 clinicians lack evidence-based guidelines for progressing patients toward higher levels of mobility. To date, standardized protocols have been described but not validated, especially with older and very old patients.2 Lack of standardization prevents patients from receiving the maximum benefit from early mobilization. The purpose of this pilot study was to determine the feasibility of employing a standard early mobilization protocol in an ICU setting, while systematically collecting patient mobility data and short-term functional outcomes from critically ill, mechanically ventilated, older adults.
Fifteen study participants were recruited from the Maine Medical Center ICU, which includes 42 critical care beds at an academic, tertiary hospital for medical and surgical patients admitted between July 1, 2010, and October 15, 2010. The Maine Medical Center institutional review board approved this study, and written informed consent was obtained from study participants or their designated proxies.
Patients in the medical or surgical ICU were screened daily by electronic medical record to identify older adult patients (aged 65 years or older) who had been mechanically ventilated for at least 48 hours with anticipation of being ventilated for a minimum of an additional 24 hours. Patients with a ventriculostomy, preadmission scores less than 70 on the Barthel Index (BI), or enrollment in another study, or who were on continuous venovenous dialysis were excluded. Patients who had been hospitalized for more than 7 days prior to intubation were also excluded.
Five commonly used measures of health and functional status were used in this study.
The RAND 36-Item Short Form Health Survey (SF-36) is a 36-question health survey used to assess self-perception of quality of life based on 8 categories (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Cronbach's alpha reliability values were 0.95, 0.98, 0.79, 0.74, 0.91, 0.88, 0.94, and 0.54, respectively, for the RAND SF-36 categories.14–20 The RAND SF-36 and BI have been validated to be accurate when taken by proxy or administered over the phone.18,19,21 The BI is a tool used to assess function in basic activities of daily living. Scores range from 0 (unable to perform activities of daily living) to 100 (total independence).22,23 Previous studies report an interrater reliability of 0.94.24 The Intensive Care Delirium Screening Checklist (DSC) for delirium screening was assessed daily in the ICU25 by nursing staff; scores 4 or greater correlate with a positive screen for delirium; previous studies have found intraobserver reliability for this screening tool to be 0.94 and a sensitivity and specificity are 99% and 64%, respectively.17,25 The Riker Sedation Agitation Scale (SAS) is a tool utilized to measure sedation and agitation in critically ill adults. Scores range from 1 (unarousable) to 7 (dangerous agitation); interrater reliability has been found to be 0.9226
Data about each patient's hospital course were also collected, including length of stay, the number of mechanical ventilator days, mortality, and location at discharge and 30-day follow-up disposition (skilled rehabilitation, acute rehabilitation, home, or death).
Descriptive information about patients included demographic information (age, gender, admission diagnoses, comorbidities, body mass index, and race), the Apache II score27,28 (used to assess disease severity and predict ICU mortality; higher scores indicate more severe disease) and information about therapy sessions including sessions attempted, sessions completed, and adverse events. Adverse events were categorized as a fall, tube removal, systolic blood pressure greater than 200 mm Hg or less than 90 mm Hg, desaturation greater than 80%, and extubation.
Once enrolled, a preadmission RAND SF-36 short form and BI score were obtained from patients or their proxies along with demographic information and an Apache II score. We employed the standardized early mobilization protocol described previously by Perme and Chandrashekar2; this mobility protocol involves a progressive mobilization and walking protocol divided into 4 phases. Each of the phases includes guidelines in positioning, therapeutic exercises, transfers, and walking along with criteria for progressing through each phase as shown in Table 1. In addition, we utilized proposed hemodynamic and neurologic guidelines by Bailey et al10 and Schweickert et al.12
Criteria used to begin activity were patient physical response (eye opening or movement) to verbal or physical stimulation (SAS between 3 and 4); activity beyond range of motion was not initiated in comatose patients. Resting respiratory criteria to initiate the mobilization protocol were Fio2≤ 0.6, positive end expiratory pressure 10 cm H2O or more, respiratory rate less than 5 or greater than 40 breaths per minute, and pulse oximetry less than 88%. Resting circulatory criteria to initiate early mobilization were as follows: mean arterial blood pressure less than 65 or greater than 110 mm Hg, systolic blood pressure greater than 200 mm Hg, heart rate less than 40 or greater than 130 beats per minute, and the absence of an increase in the dose of any catecholamine drips within the past 2 hours prior to therapy.
Mobilization procedures were provided by licensed physical and occupational therapists, which were familiar with the progression of the Perme and Chandrashekar2 early mobilization protocol. In phase I, the mobilization goals focus on bed mobility including rolling, scooting/bridging, supine to sit, and sitting edge of bed. Progress to phase II requires the patient to be able to follow commands, demonstrate acceptable hemodynamic and oxygenation responses, and tolerate standing with weight shifts. In phase II, the mobilization goals include gaining independence in phase I activities with the addition of performing transfers to a bedside chair. Progressing to phase III requires the patient to be able to demonstrate acceptable hemodynamic and oxygenation responses with transfer training. In phase III, the mobilization goals include gaining independence in phase I and II activities with the addition of walking education focusing on increasing distances walked and endurance. Progressing to phase IV requires the patient to be able to demonstrate acceptable hemodynamic and oxygenation responses with walking education. In phase IV, the mobilization goals include gaining independence in phase I, II, and II activities with the addition of removal of assistive devices (as appropriate) and training on stairs, curbs, ramps, etc. The early mobilization protocol was continued until hospital discharge. No specific attempt was made to coordinate the timing of early mobilization sessions with sedation lightening: patients participated in therapy when available to do so and deemed stable on the basis of their hemodynamic stability. The BI was administered weekly. A BI score and repeat RAND SF-36 were done on the day of hospital discharge. A phone call was made 30 days after discharge to repeat the RAND SF-36 and BI and assess location of patient (rehabilitation facility or home). All other aspects of care were done consistent with standard care practices.
Descriptive statistics (means, standard deviations, and proportions) were reported to characterize patient demographic and hospital stay data. Comparison of survivors' to nonsurvivors' demographic and hospital stay data were conducted using the Student independent t tests for continuous data and chi-square with Yates continuity correction for proportional data. Comparison of SF-36 scores between survivors, nonsurvivors, and published normative data was conducted using the Student independent t tests. All analyses were conducted using SPSS version 20.0 (IBM, Armonk, New York).
Two hundred thirty-seven patients older than 65 years were admitted to the ICUs during the 3.5-month time frame. Forty older adult patients were intubated for more than 48 hours; of these, 14 were excluded on the basis of the exclusion criteria, 8 declined to participate in the study, and 3 patients died prior to consenting.
A total of 15 participants, 8 men and 7 women averaging 76 years old, were enrolled (Table 2). No clinically significant differences were found between survivors' and nonsurvivors' baseline characteristics. Although not significant, there was a trend toward a higher body mass index in the nonsurvivors group. Primary diagnoses were as follows: vascular (3), respiratory (3), cardiovascular (3), trauma (2), gastrointestinal (1), neurologic (2), and oncologic (1). Participants spent an average of 23 days in the hospital, 13 days in the ICU, and 11 days on a ventilator. All 15 subjects remained intubated for at least 72 hours. Thirteen of the 15 baseline assessments (BI and RAND SF-36) were completed by the patient's proxy.
Five of the 15 patients died prior to discharge from the ICU. This percentage is consistent with previous mortality rates in this population cited in critical care literature.23,29,30 Of the 10 remaining survivors, 1 patient was discharged directly home from the hospital. Five patients were discharged to an acute rehabilitation hospital and 4 were discharged to a skilled nursing facility. At 30-day follow-up, 6 patients were living back at home, 2 patients remained at rehabilitation facilities (anticipating discharge to home within the next week), 1 patient was readmitted to the hospital 1 week after discharge, and 1 patient had died. Table 3 demonstrates the mean and standard deviation for those participants who survived to 30-day follow-up and those who did not survive.
There were 186 possible therapy sessions total, with a total therapy time of 5980 minutes, among the 15 patients. Of these possible sessions, patients met criteria for early mobilization 92% of the time (171/186), and patients met criteria for therapy based on the earlier-stated guidelines. The most common reason (33%) for not meeting criteria was a depressed neurologic status. The second most common reason was due to changing or unstable respiratory status (27%). Of the 171 attempted early mobilization sessions, 169 were completed (98.8%). The only 2 sessions that were not completed were due to increased respiratory rate; these patients recovered with rest. Patients were mobilized while intubated 24% of the time (41/171). In the ICU, 86% of activities were in phase I, 12% of activities were in phase II, and 2% of activities were in phase III. No patients were able to achieve phase IV activity in the ICU. On the medical floor, 49% of activities were in phase I, 20% of activities were in phase II, 30% of activities were in phase III, and only 1% of activities were in phase IV. Of 171 mobilization sessions, there was 1 adverse event, a transient drop in blood pressure that resolved with rest and short-term increase in catecholamine dose.
Patients had an SAS of less than 3 (inability to follow commands) 30% of the time during therapy. Sedation lightening was attempted 70% of the time; the number 1 reason sedation lightening was not attempted was due to illness severity and hemodynamic instability 40% of the time. Sedation lightening coincided with therapy only 3% of the time. The number 1 reason sedation lightening did not coincide with therapy was due to early morning (between 6:00 and 8:00 am) sedation lightening attempts and afternoon therapy sessions.
A total of 109 DSC worksheets were completed and 76 DSC worksheets were incomplete or missing. Most common reason for sheets not being completed was admission or discharge/expiration of the patient from the ICU (39.5%). Of the screens completed, 45% had scores 4 or greater, which is a positive screen for delirium.
Barthel Index Scores
Mean BI on preadmission, hospital discharge, and 30-day follow-up were 97, 42, and 86, respectively. Patients who survived to 30-day follow-up recovered 89% of baseline function based on the BI.
RAND SF-36 Scores
Admission RAND SF-36 scores for 30-day survivors were equivalent to SF-36 norms for community-dwelling persons older than 75 years18 as is demonstrated by Figure 1. Survivors reported significantly higher scores than nonsurvivors upon admission on both the physical functioning and general health SF-36 subscales (Table 4). Nonsurvivors reported significantly lower physical functioning, general health, vitality, and mental health upon admission than the published normative SF-36 data for patients aged 75 years and older.
RAND SF-36 scores at 30-day follow-up for those who survived were comparative to norms of community-dwelling elders older than 75 years. However, these patients reported significantly more bodily pain at 30-day follow-up compared to the published normative data as shown in Figure 2.
The primary finding of this pilot study was that a previously described standardized early mobilization protocol was feasible, safe, and well-tolerated by a small sample of critically ill, mechanically ventilated older and very old adult patients. Survivors recovered the majority (89%) of their pre-ICU basic activities of daily living and mobility function at 30 days. Two-thirds of 30-day survivors were home at 30-day follow-up.
Those who survived to 30-day follow-up had similar scores on RAND SF-36 when compared with norms of community-dwelling persons older than 75 years. Participants in early mobilization at 30 days were similar in the categories of physical function, role physical, bodily pain, general health, and role emotional as graded by the RAND SF-36 compared with normative data for community-dwelling persons older than 75 years. This differs from previous study results looking at ICU outcomes in older adult patients. Previous studies measuring quality of life in geriatric patients after discharge from ICUs show a decline in physical categories on quality-of-life surveys.31 Our finding of statistically significant improvement in the mental health and role emotional categories is consistent with previous studies.30,31 This is likely attributed to survival outlook following a traumatic medical event.
This study clearly has several limitations. It was designed to be a pilot study looking at feasibility and safety of early mobilization in a mechanically ventilated older adults. While our numbers are small, it does represent the population of general critically ill older adults as it contains surgical and medical ICU patients. While we did measure physical and quality-of-life outcomes, these outcomes should be taken in the context of small numbers. Although we outlined a more structured protocol, there is still variation in therapy dosing (time and intensity) among therapists.
Further studies are needed to determine, more accurately, the benefits of early mobilization in a larger sample of the geriatric ICU population. A study of longer duration of follow-up would help determine whether the benefits of perceived mental health continue over time. More information related to higher, community functioning needs to be obtained in future studies as patients were near the highest score possible on the BI, at 30 days' posthospital discharge, which measures basic function of activities of daily living. Possible instruments to assess high functioning in the community would include the Life Space Assessment32 or the Physical Activity Scale for the Elderly.33 In addition, identifying other predictors of mortality that involve utilization of all or portions of the RAND SF-36 could be explored.
Early mobilization requires a multidisciplinary team and is labor-intensive. Further studies should determine dosing value and cost-effectiveness of treatment.
Implementing therapeutic protocols for early mobilization of critically ill mechanically ventilated older adults is feasible and safe in a multidisciplinary setting. Older adult patients were able to participate in therapeutic procedures the majority of the time. Early mobilization is likely to improve independence in activities of daily living and allow patients to return home following acute rehabilitation.
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© 2013 The Section on Geriatrics of the American Physical Therapy Association.