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临床试验/CTRI/2021/06/033997
CTRI/2021/06/033997招募中不适用

Prospective observational study to evaluate the significance of rapid shallow breathing index rate at extubation for patient undergoing general anaesthesia.

Dr Pramila S Kurkal1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
1)sequential rapid shallow breathing index at every minute and at extubation

研究概览

简要总结

Intubation and extubation are the main concerns of anaesthetist. The process of successful post anaesthesia extubation is a great challenge for the anaesthesiologist working in the operation theater. As an anesthesiologist when we are extubating the surgical patient, three things we keep in our mind (make sure that are fulfilled).1st is patient respiratory muscle power is back to normal so that he can breathe independently without any aid. This is done by normal extubation criteria which are subjective like lifting the head, moving all four limbs etc. and its indirectly indicate that respiratory muscle power is also back to normal. 2nd wakefulness, obeying command, answering by nodding the head, Ramsey sedation score. 3rd hemodynamic stability. All the above three criteria have to be fulfilled before extubation.  Despite several advances in the care of post anaesthesia extubation, failed extubation remains a significant problem faced by the anaesthesiologist that may result into poor patient outcomes. Concerns have been highlighted by different airway societies in their guidelines. Extubation concerns have been well emphasized in the American society of anaesthesiologist closed claims analysis and national audit project 4 (NAP4). The NAP4 report studied the airway-related issues and observed a mortality rate of 5% in patients with extubation failure after general anaesthesia. They reported an incidence of 13% for severe outcomes after extubation failure.

Rapid shallow breathing index (RSBI) is a tool that is use in the weaning of mechanical ventilation in intensive care units. The rapid shallow breathing index (RSBI) is defined as the ratio of respiratory frequency to tidal volume in liter (f/VT). And RSBI rate is defined as sum total of [(RSBI1min – RSBIextubation) / RSBI1min] x 100. The cut-off point of RSBI in an Intensive care unit setup is 105. If the cut-off for the patient is more than 105 the patient is not ready for extubation. This fact has been successfully proved well beyond doubt in intensive care setup as a major tool used for weaning the ventilated patient gradually and keeping them independent of any aid for ventilator. Most Of the existing extubation criteria are subjective except train of four ratio (TOF) which is objective. Its already established gold standard in anaesthesia but for that you Need to purchase peripheral nerve stimulator, electrode cost will be incurred by the patient, might be painful manier time as patient is coming out of anaesthesia, extra work for an anesthetist. While the RSBI is an objective, no any extra machine requirement, easy to calculate, cost free, no extra work involved and not painful. We have kept the TOF ratio constant for all our patients at 0.9 which is an optimum point at which reversal is generally considered. After reversal the conventional, time tested, clinical extubation criteria are assessed.  At this time sequential RSBI at every minute and at extubation RSBI is noted based on this rapid shallow breathing index rate will be calculated. And the time lapse between reversal and extubation is also noted. Recent anaesthesia machines easily display tidal volume and the respiratory rate generated by the patient which makes it easy to calculate RSBI. The RSBI is noninvasive, easy to calculate, no additional cost involved and an objective parameter. This can be a very useful additional tool to existing post anaesthesia extubation criteria.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •1.ASA grade 1 and 2 patients
  • •Age group from 18 to 65 years
  • •Both sexes
  • •Patients willing to be a part of study.

排除标准

  • •Airway disease 1.1 obstructive lung disease 1.2 restrictive lung disease
  • •Cardio thoracic vascular surgery.
  • •History of neurological problems like cerebrovascular accident, head injury, spine injuries.
  • •Neurodegenerative disorders, neuromuscular disorders.
  • •Patient on psychotropic drugs
  • •Chronic smoker
  • •Major abdominal surgery, lung surgery
  • •Obstructive sleep pane
  • •Refusal to be a part of the study.

结局指标

主要结局

1)sequential rapid shallow breathing index at every minute and at extubation

时间窗: 1)sequential rapid shallow breathing index at every minute and at extubation | 2)Rapid shallow breathing index rate

2)Rapid shallow breathing index rate

时间窗: 1)sequential rapid shallow breathing index at every minute and at extubation | 2)Rapid shallow breathing index rate

次要结局

  • Time lapse from reversal to extubation(30 minutes)

研究者

发起方
Dr Pramila S Kurkal
申办方类型
Research institution and hospital

研究点 (1)

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