Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care

Study on the Improvement of Neurological Function and Prognostic Efficacy of Enhanced Recovery After Surgery in Neurocritical Care Patients: a Single-Center Prospective Randomized Controlled Clinical Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury; Cerebrovascular Disease; Neurocritical Care; Moderate or Severe Coma
• Intervention / Treatment: Procedure: Enhanced recovery after surgery; Procedure: Conventional therapy

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hao Chen, M.D., Ph.D.; Phone Number: 8405 8602164369181; Email: hao.chen@shsmu.edu.cn

Study Locations

• China
  • Shanghai, China, 200233
    • Shanghai 6th People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced recovery after surgery; The technologies, processes and measures of enhanced recovery after surgery were applied.	Procedure: Enhanced recovery after surgery; The technologies, processes and measures of enhanced recovery after surgery focus on the following aspects: Early assessment and treatment; Optimized anesthetic protocol; Reducing surgical stress; Multi-modal comprehensive monitoring; Comprehensive diagnosis and treatment in neurosurgical intensive care; Intensive early rehabilitation treatment
Active Comparator: Conventional therapy; Conventional therapy were applied.	Procedure: Conventional therapy; Conventional therapy in neurocritical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	One month, three and six months after injury or attack
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)	One month, three and six months after injury or attack

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroimaging evaluation	Computer tomography or magnetic resonance imaging	One week, two weeks after surgery; one month, three and six months after injury or attack

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital
• Investigators: Study Director: Hao Chen, M.D., Ph.D., Shanghai 6th Peoples' Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: January 20, 2024
• First Submitted That Met QC Criteria: January 27, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Cerebrovascular Disease; Neurocritical Care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Cerebrovascular Disorders
• Other Study ID Numbers: In application process

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No