NCT07037615

The Impact of Different Sedation Regimens on Hemodynamics in Patients Undergoing Mechanical Ventilation With Shock

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Mechanical ventilation is a common therapeutic intervention in the intensive care unit (ICU). However, patients undergoing mechanical ventilation often experience agitation, unplanned extubation, patient-ventilator asynchrony, and even neuroendocrine-immune dysregulation, sympathetic overexcitation, and organ dysfunction due to discomfort and pain. Sedation therapy mitigates patient stress, enhances comfort, and ensures the smooth implementation of mechanical ventilation, making it an essential component of treatment for ventilated patients. Nevertheless, sedation may impact peripheral vascular tone, leading to hemodynamic instability and exacerbating inadequate peripheral perfusion. The precise implementation of sedation therapy to minimize adverse effects remains unclear. This prospective observational study will enroll critically ill patients with shock requiring mechanical ventilation. We will examine the effects of different sedation strategies-including sedation assessment protocols, sedative types, sedation duration, and daily awakening trials-on hemodynamics in this population. The study aims to explore optimized sedation regimens and provide evidence-based guidance for precision sedation therapy in clinical practice.

Detailed description

Critically ill patients requiring mechanical ventilation in the ICU frequently present with concurrent shock. The hemodynamic effects of sedative agents may further exacerbate circulatory instability. Studies indicate that 34% of ICU patients require simultaneous mechanical ventilation and vasoactive agent support. Among ARDS patients, over 60% develop shock, with approximately 65% necessitating vasopressor administration. Common sedatives like propofol and dexmedetomidine, despite being first-line choices, exhibit significant hemodynamic side effects: * \*\*Propofol\*\* induces hypotension (incidence: 20%) through vasodilation, sympathetic suppression, and bradycardia. * \*\*Dexmedetomidine\*\* causes hypotension and bradycardia at low doses, while triggering vasoconstriction via peripheral α-2 receptor activation at high doses-both scenarios reduce cardiac output. Additional factors affecting hemodynamic stability include sedation depth, duration, and daily awakening protocols. Deep sedation may mask dynamic assessment of fluid responsiveness, delaying shock resuscitation. Conversely, daily awakening-though reducing ventilation duration-may increase circulatory fluctuations through stress responses. These complex interactions necessitate balancing sedation efficacy and circulatory stability in shock patients, yet standardized protocols for this population remain lacking.

Conditions

• Mechanically Ventilated Patients With Shock

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2025-06-25
• Last updated: 2025-07-09