Mechanically ventilated patients in intensive care units commonly receive sedative therapy based on clinician observation of arousal and motor activity. The study's rationale notes potential negative consequences when sedation is provider-directed and limited mitigation of patient symptoms. The trial aimed to assess preliminary efficacy of patient self-management of sedative therapy compared with usual nurse-administered sedation. Primary outcomes were self-reported anxiety, duration of mechanical ventilation, and incidence of delirium measured by CAM-ICU.
This was a two-group, open-label, randomized, multicenter clinical trial conducted in five Midwestern hospitals. Patients receiving invasive mechanical ventilation who were willing and able to use a push-button device were enrolled and randomized in a 1:1 ratio using center-stratified blocks. The protocol allowed up to 7 days of study intervention per patient.
A total of 161 patients were randomized: 81 to usual care and 80 to the intervention. The sample had a median age of 62 years, was 54.7% female, and 92.5% Caucasian. Participants remained on protocol for a median of 88 hours. Nine patients randomized to the intervention were extubated prior to protocol initiation and therefore did not receive the intervention as intended.
Intervention patients used a bedside push-button device to self-administer dexmedetomidine boluses. Each allowable bolus was 0.25 mcg/kg, with a limit of three boluses per hour and a 20-minute lock-out after each bolus. A starting basal infusion of 0.2 mcg/kg/hr was initiated, and bedside nurses adjusted the basal rate between 0.1 and 0.7 mcg/kg/hr. Nurses made adjustments based on the number of patient-delivered boluses in the preceding two hours.
Patients randomized to usual care received nurse-administered sedation according to local practice. The trial compared outcomes between the patient self-management intervention and this usual care arm. Details about specific sedative regimens used in the usual care group beyond general nurse-directed administration were not reported in the abstract.
Patients self-rated anxiety three times daily using a visual analog scale (VAS) ranging 0–100. The primary analyses for anxiety and duration of mechanical ventilation used linear mixed-effects models to compare groups over time. Incidence of delirium, assessed with the CAM-ICU instrument, was analyzed using generalized estimating equations. Both intention-to-treat (ITT) and per-protocol (PP) analyses were reported where applicable.
Self-reported anxiety ratings collected three times daily on the VAS were analyzed over time. There was no significant difference in anxiety between intervention and usual care groups in the ITT analysis (p = 0.94) or in the PP analysis (p = 0.30).
Duration of mechanical ventilation was compared between groups. In the ITT analysis, intervention patients had a shorter mean duration of mechanical ventilation (50.8 hours, SD 52.8) compared with usual care (68.7 hours, SD 58.2), with a reported p value of 0.02. However, the PP analysis did not show a significant difference (intervention mean 56.4 hours, SD 53.0 vs usual care 68.7 hours, SD 58.2; p = 0.23).
New incidence of delirium during the study period occurred in 10.2% of intervention patients and 8.5% of usual care patients. These differences were not statistically significant in either ITT (p = 0.65) or PP analyses (p = 0.58).
The trial demonstrated feasibility of a push-button, patient-directed sedation approach using dexmedetomidine for mechanically ventilated adults who were willing and able to use the device. No significant differences in delirium incidence were observed between groups. The abstract does not report other safety event rates, specific adverse events, or detailed device-related complications; those details were not reported in the source abstract.
The investigators concluded that patient self-administration of sedative therapy produced similar outcomes to usual nurse-administered care across measured endpoints. They describe the intervention as a safe, novel, patient-centered approach and recommend further rigorous investigation to evaluate its role for anxiety self-management in mechanically ventilated patients.
Anxiety; delirium; intensive care unit; invasive mechanical ventilation; sedation
(Details in this summary are drawn from the published abstract. The abstract does not provide full protocol details, comprehensive safety data, or longer-term outcomes.)