Clinical trial NCT06241482: Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care
Official title: A Randomized Controlled Clinical Study on Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurocritical Care
Traumatic Brain Injury
Cerebrovascular Disease
Moderate or Severe Coma
Keywords: Neurocritical Care
Traumatic Brain Injury
Cerebrovascular Disease
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2024-02-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Enhanced recovery after surgery (ERAS) is a strategy of perioperative management aimed to accelerate the rehabilitation of patients through various optimized perioperative managements as well as ongoing adherence to a patient-focused, multidisciplinary, and multimodal approach. Alleviating the injury and stress caused by surgery or disease is the core principle of ERAS, which has been shown to reduce complication rates after surgery, promote patient recovery, decrease hospital length of stay and reduce costs. ERAS has been widely applied in many surgical perioperative fields, and it has achieved remarkable effects. However, there are few applications of ERAS in neurosurgery, especially in clinical trials of neurocritical care patients.

Therefore, the investigators attempt to conduct the study of ERAS in neurosurgical intensive patients using a series of optimized perioperative managements that have been verified to be effective by evidence-based medicine, and to evaluate the safety and effectiveness of ERAS in neurocritical care. The aim of this study is to explore the most suitable ERAS protocols to accelerate the postoperative rehabilitation process of neurocritical care patients, and to provide more evidence-based medicine for the effectiveness and safety of ERAS in neurosurgery.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years old
* Patients with moderate or severe acute traumatic brain injury or cerebrovascular disease requiring neurosurgical intensive care treatment
* Hospitalization time ≥ 1 week
* The guardian is able to understand and actively cooperate in completing the project
* The guardian signs an informed consent form

Exclusion Criteria:

* Patients undergoing non-surgical treatment
* Patients diagnosed as brain death within the first 24 hours after admission to NICU
* Patients undergoing cardiopulmonary resuscitation, maintenance dialysis, end-stage tumors, and disseminated cancer
* Patients who withdraw treatment during hospitalization or are discharged automatically
* Patients who underwent unplanned secondary surgery during the research process
* Individuals who cannot be followed up during the research process

Primary outcomes:
measure: Clinical prognosis
timeFrame: One month, three and six months after injury or attack
measure: Neurological function assessment
timeFrame: One month, three and six months after injury or attack
Secondary outcomes:
measure: Neuroimaging evaluation
timeFrame: One week, two weeks after surgery; one month, three and six months after injury or attack
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
Study officials:
affiliation: Shanghai 6th Peoples' Hospital
name: Hao Chen, M.D., Ph.D.
role: STUDY_DIRECTOR
References: