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临床试验/NCT03291119
NCT03291119Unknown不适用

To Evaluate the Predictors of Risk Factors for Extubation Failure After Cervico-Vertebral Junction Surgery-A Prospective Observational Study.

Post Graduate Institute of Medical Education and Research, Chandigarh0 个研究点目标入组 100 人开始时间: 2017年10月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Extubation failure will be evaluated in patients undergoing surgeries for CVJ surgery.

研究概览

简要总结

CVJ anomalies affecting skeleton might lead to the pressure on the neuraxis, and disturbance of the cerebrospinal fluid circulation and blood supply. The patients undergoing surgeries on CVJ might develop airway complications in immediate postoperative period warranting urgent reintubation or emergency tracheostomy. Reintubation is usually difficult in immediate postoperative period due the fixation of cervical spine and gross upper airway oedema due to prolonged surgery in prone position. This will be the first prospective observational study to find out the risk factors related to patient, anaesthesia, radiological findings and surgical procedure to predict extubation failure in patients undergoing CVJ surgeries.

详细描述

Research Query We conducted a pilot study and found that the incidence of reintubation is 20%. Reintubation poses a clinical, psychological and financial burden on the patients. Consequently, our study aims to identify the various risk factors to predict the need for reintubation and postoperative mechanical ventilation so that success of extubation can be anticipated.

Introduction:

The craniovertebral junction (CVJ) includes the basiocciput, atlas, axis and various supporting ligaments. The contents enclosed in CVJ include Medulla, cervical spinal cord (cervico-medullary junction), spinal arteries, and lower cranial and cervical nerves1. CVJ anomalies affecting skeleton might lead to the pressure on the neuraxis and disturbance of the cerebrospinal fluid circulation and blood supply. The clinical manifestations of CVJ abnormalities include weakness of both upper and lower limbs, respiratory dysfunction due to compression of the respiratory centres in brainstem and weakness of respiratory muscles including diaphragm2. The patients undergoing surgeries on CVJ might develop airway complications in immediate postoperative period warranting urgent reintubation or emergency tracheostomy3. Reintubation is usually difficult in immediate postoperative period in the view of fixation of cervical spine and gross upper airway oedema due to prolonged surgery in prone position4,5. To avoid such airway emergencies few centres favour to delay the extubation. The patients with weak respiratory muscles and poor respiratory reserve tend to develop major pulmonary complications and become ventilator dependant so, we always plan an early weaning and extubation6-9.

Epstein et al10 reported that the potential risk factors associated with postoperative emergency airway management following cervical spine surgery included; obesity (>220 ponds), surgery duration greater than 10 hours, anterior corpectomy with fusion of second cervical vertebra, greater than 4 units of transfused blood, asthma, advanced age (>65 years), a cerebrospinal fluid fistula, extent surgery, and severe preoperative neurologic deficit. These risk factors are generalised for all cervical surgeries. CVJ is an important area where most of the vital centres present in medulla are at risk of injuries that leads to central respiratory depression and even sudden death. These patients can have airway and respiratory compromise even in the absence of the risk factors described by Epstein et al10. Hence, we plan to conduct this study to identify the risk factors leading to extubation failure in patients undergoing surgeries for CVJ anomalies, so that, early or delayed extubation can be planned before the end of surgery.

NOVELTY:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Extubation failure will be evaluated in patients undergoing surgeries for CVJ surgery.

时间窗: 1 year

Extubation failure is defined as failure to extubate or reintubation with in 24 Hrs postoperatively.

次要结局

  • The association of various predictors with Outcome will be determined(1 year)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kiran Jangra

Principle Investigator

Post Graduate Institute of Medical Education and Research, Chandigarh

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