The Effect of Implementing a Daily Awakening Protocol on Treatment Outcomes of Mechanically Ventilated Patients Hospitalized in the Intensive Care Unit: A Randomized Clinical Trial Study

Abstract

Background: Mechanically ventilated patients in the intensive care unit (ICU) are at risk of complications associated with prolonged sedation. Although daily sedation interruption (DSI) and sensory stimulation are each beneficial, their combined use within a daily awakening protocol has not been investigated. Objectives: This study aimed to evaluate the effects of implementing a daily awakening protocol on treatment outcomes in mechanically ventilated patients in the ICU. Methods: This randomized clinical trial was conducted in two general ICUs at a hospital affiliated with Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran, from January to August 2025. Ninety ICU patients were assigned to the intervention and control groups using permuted block randomization. The intervention group received a daily awakening protocol that included DSI and sensory stimulation at a specified time, whereas the control group received DSI alone. Data were collected using the Glasgow Coma Scale (GCS), Richmond Agitation-Sedation Scale (RASS), Confusion Assessment Method for the ICU (CAM-ICU), and the APACHE II score and were analyzed using SPSS version 22, with a significance level of P < 0.05. Results: The mean age of the participants was 38.41 ± 14.77 years, and most were male (67.5%). Baseline characteristics were comparable between the groups (all P > 0.05). Glasgow Coma Scale scores improved over time in both groups (P < 0.001), with greater improvement in the intervention group (partial η2 = 0.527 vs. 0.465). For RASS, the time × group interaction was significant (P < 0.001). The intervention group became calmer, with scores moving toward 0 or -1, whereas the control group became more agitated, with scores shifting toward positive values. Compared with the control group, the intervention group had a shorter ICU stay (18.66 ± 7.20 vs. 23.24 ± 5.99 days; P = 0.001) and a shorter duration of mechanical ventilation (13.73 ± 6.94 vs. 18.21 ± 4.01 days; P < 0.001). Delirium incidence was lower in the intervention group (26.2% vs. 51.2%; P = 0.016), whereas ICU mortality was similar between the groups (11.9% vs. 14.6%; P = 0.561). Conclusions: This study showed that a daily awakening protocol combining DSI with multisensory stimulation reduced the duration of mechanical ventilation, ICU stay, and delirium while improving consciousness and sedation-agitation status. Therefore, integrating this protocol into routine sedation management and training nurses in structured sensory stimulation may improve patient outcomes.