IMPORTANCE Alternatives to sedative medications, such as music, may alleviate the anxiety associated with ventilatory support. OBJECTIVE To test whether listening to self-initiated patient-directed ...music (PDM) can reduce anxiety and sedative exposure during ventilatory support in critically ill patients. DESIGN, SETTING, AND PATIENTS Randomized clinical trial that enrolled 373 patients from 12 intensive care units (ICUs) at 5 hospitals in the Minneapolis-St Paul, Minnesota, area receiving acute mechanical ventilatory support for respiratory failure between September 2006 and March 2011. Of the patients included in the study, 86% were white, 52% were female, and the mean (SD) age was 59 (14) years. The patients had a mean (SD) Acute Physiology, Age and Chronic Health Evaluation III score of 63 (21.6) and a mean (SD) of 5.7 (6.4) study days. INTERVENTIONS Self-initiated PDM (n = 126) with preferred selections tailored by a music therapist whenever desired while receiving ventilatory support, self-initiated use of noise-canceling headphones (NCH; n = 122), or usual care (n = 125). MAIN OUTCOMES AND MEASURES Daily assessments of anxiety (on 100-mm visual analog scale) and 2 aggregate measures of sedative exposure (intensity and frequency). RESULTS Patients in the PDM group listened to music for a mean (SD) of 79.8 (126) (median range, 12 0-796) minutes/day. Patients in the NCH group wore the noise-abating headphones for a mean (SD) of 34.0 (89.6) (median range, 0 0-916) minutes/day. The mixed-models analysis showed that at any time point, patients in the PDM group had an anxiety score that was 19.5 points lower (95% CI, −32.2 to −6.8) than patients in the usual care group (P = .003). By the fifth study day, anxiety was reduced by 36.5% in PDM patients. The treatment × time interaction showed that PDM significantly reduced both measures of sedative exposure. Compared with usual care, the PDM group had reduced sedation intensity by −0.18 (95% CI, −0.36 to −0.004) points/day (P = .05) and had reduced frequency by −0.21 (95% CI, −0.37 to −0.05) points/day (P = .01). The PDM group had reduced sedation frequency by −0.18 (95% CI, −0.36 to −0.004) points/day vs the NCH group (P = .04). By the fifth study day, the PDM patients received 2 fewer sedative doses (reduction of 38%) and had a reduction of 36% in sedation intensity. CONCLUSIONS AND RELEVANCE Among ICU patients receiving acute ventilatory support for respiratory failure, PDM resulted in greater reduction in anxiety compared with usual care, but not compared with NCH. Concurrently, PDM resulted in greater reduction in sedation frequency compared with usual care or NCH, and greater reduction in sedation intensity compared with usual care, but not compared with NCH. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00440700
Objective
To determine the relationship between measures of critical illness (sedative/analgesic administration, wakefulness and organ dysfunction), intensive care unit (ICU) recall and symptoms of ...posttraumatic stress disorder.
Design
Prospective, observational study with post-ICU follow-up.
Setting
Medical and surgical ICUs at a teaching hospital.
Patients
Two hundred seventy-seven subjects requiring > 36 h of mechanical ventilation were enrolled; 149 completed follow-up interviews 2 months later and 80 at 6 months.
Interventions
None.
Results
ICU recall was greater for events occurring at the end of critical illness; however, 18% of subjects had amnesia for the entire ICU course. Factual ICU recall was weakly associated with increased wakefulness during mechanical ventilation (
r
2
= 0.03–0.11,
p
< 0.05). Posttraumatic stress disorder prevalence was 17% at 2 months and 15% at 6 months. The avoidance-numbing cluster had the highest specificity (91%) for a formal diagnosis and the re-experiencing cluster had the lowest (69%). Recall of a delirious memory during critical illness was associated with more severe posttraumatic stress symptoms, but there was no association between posttraumatic stress symptoms and factual recall of ICU events. Neither ICU recall nor posttraumatic stress symptoms were associated with the intensity of sedative administration during mechanical ventilation. Posttraumatic stress symptoms were lowest in patients either the most awake during mechanical ventilation or the least awake.
Conclusion
Wakefulness during mechanical ventilation has a greater influence on post-ICU recall and posttraumatic stress symptoms than sedative drug exposure or severity of illness. It is difficult to predict the future psychological consequences of an individual patient's critical illness.
OBJECTIVE:Describe the pharmacoepidemiology of sedative medications and nurse-rated patientsʼ behavior and sedation adequacy.
DESIGN:Cohort study, 2001–2003.
PATIENTS:Patients ventilated for >36 hrs ...in a medical or surgical intensive care unit at a university-affiliated hospital. Proxies for 312 eligible subjects were approached for consent, 277 subjects enrolled, and data from 274 subjects were analyzed.
INTERVENTIONS:None.
MEASUREMENTS AND MAIN RESULTS:Distribution of Arousal and Motor Activity levels, proportion of inadequate sedation and factors associated with inadequate sedation, variation of sedative therapy intensity, and behavior over time were measured. Sedatives were administered in 85% of 18,050 four-hour intervals during mechanical ventilation. Sedation was judged as adequate in 83% of 12,414 sedation assessments; patients were judged to be undersedated in 13.9% and oversedated in 2.6% of the assessments. Patients were unarousable or minimally arousable 32% of the time and had no spontaneous motor activity (during a 10-min observation period) 21.5% of the time. There was little variation in level of consciousness or motor activity or drug dose over 24 hrs, but daytime caregivers were more likely to judge patients as oversedated (3.7%) compared with nighttime caregivers (1.6%, p < .001). Inadequate sedation was associated with sedative drug intensity and patient behavior as measured by a two-domain sedation scale. Sedative drug intensity and behavior varied during the course of respiratory failure, and survivors received 13% more sedation per 4-hr interval of mechanical ventilation than nonsurvivors (p < .001).
CONCLUSIONS:Although patients were minimally arousable or nonarousable in 32% and motionless in 21% of the sedation assessments, surprisingly, an oversedation rating occurred in <3%. This discrepancy, along with findings that time of day influences the interpretation of sedation adequacy and that patientsʼ behavior change over time suggests that collaborative research is needed to define adequate sedation.
Administration of sedative and opioid medications to patients receiving mechanical ventilatory support in the intensive care unit is a common clinical practice.
A two-site randomized open-label ...clinical trial will test the efficacy of self-management of sedative therapy with dexmedetomidine compared to usual care on anxiety, delirium, and duration of ventilatory support after randomization. Secondary objectives are to compare self-management of sedative therapy to usual care on level of alertness, total aggregate sedative and opioid medication exposure, and ventilator-free days up to day 28 after study enrolment. Exploratory objectives of the study are to compare self-management of sedative therapy to usual care on 3- and 6-month post-discharge physical and functional status, psychological well-being (depression, symptoms of post-traumatic stress disorder), health-related quality of life, and recollections of ICU care. ICU patients (n = 190) who are alert enough to follow commands to self-manage sedative therapy are randomly assigned to self-management of sedative therapy or usual care. Patients remain in the ICU sedative medication study phase for up to 7 days as long as mechanically ventilated.
The care of critically ill mechanically ventilated patients can change significantly over the course of a 5-year clinical trial. Changes in sedation and pain interventions, oxygenation approaches, and standards related to extubation have substantially impacted consistency in the number of eligible patients over time. In addition, the COVID-19 pandemic resulted in mandated extended pauses in trial enrolment as well as alterations in recruitment methods out of concern for study personnel safety and availability of protective equipment. Patient triaging among healthcare institutions due to COVID-19 cases also has resulted in inconsistent access to the eligible study population. This has made it even more imperative for the study team to be flexible and innovative to identify and enrol all eligible participants. Patient-controlled sedation is a novel approach to the management of patient symptoms that may be able to alleviate mechanical ventilation-induced distress without serious side effects. Findings from this study will provide insight into the efficacy of this approach on short- and long-term outcomes in a subset of mechanically ventilated patients.
ClinicalTrials.gov NCT02819141. Registered on June 29, 2016.
Background
Patients undergoing alcohol withdrawal in the intensive care unit (ICU) often require escalating doses of benzodiazepines and not uncommonly require intubation and mechanical ventilation ...for airway protection. This may lead to complications and prolonged ICU stays. Experimental studies and single case reports suggest the α
2
-agonist dexmedetomidine is effective in managing the autonomic symptoms seen with alcohol withdrawal. We report a retrospective analysis of 20 ICU patients treated with dexmedetomidine for benzodiazepine-refractory alcohol withdrawal.
Methods
Records from a 23-bed mixed medical-surgical ICU were abstracted from November 2008 to November 2010 for patients who received dexmedetomidine for alcohol withdrawal. The main analysis compared alcohol withdrawal severity scores and medication doses for 24 h before dexmedetomidine therapy with values during the first 24 h of dexmedetomidine therapy.
Results
There was a 61.5% reduction in benzodiazepine dosing after initiation of dexmedetomidine (n = 17;
p <
0
.
001) and a 21.1% reduction in alcohol withdrawal severity score (n = 11;
p
= .015). Patients experienced less tachycardia and systolic hypertension following dexmedetomidine initiation. One patient out of 20 required intubation. A serious adverse effect occurred in one patient, in whom dexmedetomidine was discontinued for two 9-second asystolic pauses noted on telemetry.
Conclusions
This observational study suggests that dexmedetomidine therapy for severe alcohol withdrawal is associated with substantially reduced benzodiazepine dosing, a decrease in alcohol withdrawal scoring and blunted hyperadrenergic cardiovascular response to ethanol abstinence. In this series, there was a low rate of mechanical ventilation associated with the above strategy. One of 20 patients suffered two 9-second asystolic pauses, which did not recur after dexmedetomidine discontinuation. Prospective trials are warranted to compare adjunct treatment with dexmedetomidine versus standard benzodiazepine therapy.
OBJECTIVE:Representatives of five international critical care societies convened topic specialists and a nonexpert jury to review, assess, and report on studies of targeted temperature management and ...to provide clinical recommendations.
DATA SOURCES:Questions were allocated to experts who reviewed their areas, made formal presentations, and responded to questions. Jurors also performed independent searches. Sources used for consensus derived exclusively from peer-reviewed reports of human and animal studies.
STUDY SELECTION:Question-specific studies were selected from literature searches; jurors independently determined the relevance of each study included in the synthesis.
CONCLUSIONS AND RECOMMENDATIONS:1) The jury opines that the term “targeted temperature management” replace “therapeutic hypothermia.”2) The jury opines that descriptors (e.g., “mild”) be replaced with explicit targeted temperature management profiles.3) The jury opines that each report of a targeted temperature management trial enumerate the physiologic effects anticipated by the investigators and actually observed and/or measured in subjects in each arm of the trial as a strategy for increasing knowledge of the dose/duration/response characteristics of temperature management. This enumeration should be kept separate from the body of the report, be organized by body systems, and be made without assertions about the impact of any specific effect on the clinical outcome.4) The jury STRONGLY RECOMMENDS targeted temperature management to a target of 32°C–34°C as the preferred treatment (vs. unstructured temperature management) of out-of-hospital adult cardiac arrest victims with a first registered electrocardiography rhythm of ventricular fibrillation or pulseless ventricular tachycardia and still unconscious after restoration of spontaneous circulation (strong recommendation, moderate quality of evidence).5) The jury WEAKLY RECOMMENDS the use of targeted temperature management to 33°C–35.5°C (vs. less structured management) in the treatment of term newborns who sustained asphyxia and exhibit acidosis and/or encephalopathy (weak recommendation, moderate quality of evidence).
Weaning from mechanical ventilation requires increased respiratory effort, which can heighten anxiety and later prolong the need for mechanical ventilation.
To examine the predictive associations of ...music intervention, anxiety, sedative exposure, and patients' characteristics on time to initiation and duration of weaning trials of patients receiving mechanical ventilation.
A descriptive, correlational design was used for a secondary analysis of data from a randomized trial. Music listening was defined as self-initiated, patient-directed music via headphones. Anxiety was measured daily with a visual analog scale. Sedative exposure was operationalized as a daily sedation intensity score and a sedative dose frequency. Analyses consisted of descriptive statistics, graphing, survival analysis, Cox proportional hazards regression, and linear regression.
Of 307 patients, 52% were women and 86% were white. Mean age was 59.3 (SD, 14.4) years, mean Acute Physiology and Chronic Health Evaluation III score was 62.9 (SD, 21.6), mean duration of ventilatory support was 8 (range, 1-52) days, and mean stay in the intensive care unit was 18 (range, 2-71) days. Music listening, anxiety levels, and sedative exposure did not influence time to initial weaning trial or duration of trials. Clinical factors of illness severity, days of weaning trials, and tracheostomy placement influenced weaning patterns in this sample.
Prospective studies of music intervention and other psychophysiological factors during weaning from mechanical ventilation are needed to better understand factors that promote successful weaning.
Reducing tidal volumes administered to patients with acute lung injury is the only intervention reported to decrease mortality resulting from this life-threatening condition. Whereas many medical ...advances are slowly brought into practice, clinicians in teaching hospitals are often assumed to be early adopters of new medical advances. Our objective was to examine trends in the ventilatory prescription for 398 patients with acute lung injury treated in three teaching hospitals from 1994 to 2001. There was no change in tidal volumes until mid to late 1998, when volumes started to slowly decline at the rate of 48.0 (95% confidence interval, 21.0 to 74.4) ml/year. In the 2 years after the results were released from a large trial that demonstrated the superiority of 6 ml/kg tidal volume therapy over 12 ml/kg, clinicians prescribed tidal volumes of 651 +/- 128 ml or 10.1 +/- 1.9 ml/kg. Tidal volumes after intubation were minimally reduced over the subsequent 2 days of mechanical ventilation (mean reduction, 33 ml). Hospital category, male sex, and disease onset before May 1999 were associated with higher volumes whereas lung injury severity was inversely associated. We conclude that clinicians practicing at these teaching hospitals have not rapidly adopted low tidal volume ventilation that may reduce mortality.
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