Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai 6th People's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced recovery after surgery
Procedure/SurgeryThe technologies, processes and measures of enhanced recovery after surgery focus on the following aspects: 1. Early assessment and treatment 2. Optimized anesthetic protocol 3. Reducing surgical stress 4. Multi-modal comprehensive monitoring 5. Comprehensive diagnosis and treatment in neurosurgical intensive care 6. Intensive early rehabilitation treatment
Conventional therapy
Procedure/SurgeryConventional therapy in neurocritical care.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Enhanced recovery after surgeryExperimental treatment 1 intervention
Group B: Conventional therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical prognosis
Glasgow Outcome Scale score (1 = death; 2 = persistent vegetative state; 3 = severe disability; 4 = moderate disability; 5 = good but not necessarily complete recovery; unfavorable outcome was defined as score of ≤3, and favorable outcome was defined as a score of \>3)
Time frame
One month, three and six months after injury or attack2
Neurological function assessment
Modified Rankin scale score (0 = no symptoms; 1 = no significant disability; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = dead; favorable outcome was defined as score of 0-2, and unfavorable outcome was defined as score of 3-6)
Time frame
One month, three and six months after injury or attackSecondary outcomes
1
Neuroimaging evaluation
Computer tomography or magnetic resonance imaging
Time frame
One week, two weeks after surgery; one month, three and six months after injury or attackSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai 6th People's Hospital
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Collaborator
Source ClinicalTrials.gov