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临床试验/NCT03091387
NCT03091387Unknown不适用

Utility of Spontaneous Breathing Trial (SBT) Using ET-CPAP, in Predicting Extubation Failure in Neonates

Aga Khan University0 个研究点目标入组 110 人开始时间: 2017年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
主要终点
Extubation failure

研究概览

简要总结

Intubation and ventilation are lifesaving interventions in the neonatal intensive care unit (ICU), especially among preterm, low birth weight babies. However, timely extubation is also necessary. The decision to extubate usually depends on clinical judgement, appropriate blood gas prior to extubation and low ventilator parameters. Approximately 40 % of babies' extubated on the above criteria require re-intubation, suggesting that current methods to predict extubation failure are insufficient. . Spontaneous breathing trial (SBT) has been predominantly used in infants and children to access the readiness for extubation. Few studies in premature neonates have also shown good sensitivity and specificity in predicting extubation success. However its significance in our population is yet to be determined. We aim to use this for both our preterm and term babies and if results are significant we plan to include this as our routine pre extubation criteria.

详细描述

Intubation and ventilation are lifesaving interventions in the neonatal intensive care unit (ICU), especially among preterm, low birth weight babies. However, timely extubation is also necessary, in order to prevent adverse effects of prolonged intubation, such as iatrogenic pneumothorax, superadded bacterial infections and colonization, subglottic injury and bronchopulmonary dysplasia1,2.

For extubation to be successful, baby should maintain hemodynamic stability and O2 saturation for at least 48 hours post-extubation. So far there are no standard guidelines, especially in low resource countries such as ours, to predict successful extubation. The decision to extubate usually depends on clinical judgement, appropriate blood gas prior to extubation and low ventilator parameters3. Intensivists may vary in their experience and training, resulting in a large variation in the timing and outcome of extubation.

Research from high income settings indicates that approximately 40 % of babies extubated on the above criteria require re-intubation, suggesting that current methods to predict extubation failure are insufficient.3 Readiness for extubation can be objectively measured by observing pulmonary functions, respiratory muscle strength, respiratory drive, ventilator flow volumes and gas exchange.5,6 Re-intubation causes prolonged hospital stay, adversely effects the family, and results in undesirable effects on the neonate4 . Therefore accurate prediction of extubation failure in neonates is a high priority. Spontaneous breathing trial (SBT) has been predominantly used in infant and children to access the readiness for extubation . Few studies in premature neonates have also shown good sensitivity and specificity in predicting extubation sucess7.However its significance in our population is yet to be determined. We aim to use this for both our preterm and term babies and if results are significant we plan to include this as our routine pre extubation criteria.

Primary Objective:

To evaluate the usefulness of SBT, in predicting extubation failure among neonates admitted to a NICU in a tertiary care hospital in Karachi, Pakistan.

研究设计

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

入排标准

年龄范围
1 Day 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates who are intubated for more than 24 hrs. AND
  • Extubation is planned by the primary team onto Nasal continuous positive airway pressure (NCPAP) for weight < 1.5 kg OR Oxygen via nasal prongs for weight ≥ 1.5 kg
  • AND having all of the following:
  • Pre extubation blood gas pH=7.25-7.45 and PCo2=35-45mmHg
  • Pre extubation fractional inspiration of oxygen (FiO2)=<40%
  • Is off sedation medication for >4 hrs
  • I-time= 0.3-0.36 sec
  • Peep: 5 cm h20
  • VTe: >3 ml/kg
  • Breathing rate above the set ventilator rate
  • Family providing written informed consent

排除标准

  • Neonates who will be extubated and kept on other modalities like high flow nasal cannula.
  • Congenital malformation like lung hypoplasia/diaphrgmatic hernia/congenital cyanotic heart disease.
  • Neonate with suspicion of neuromuscular disorder.
  • Neonates with accidental extubation

结局指标

主要结局

Extubation failure

时间窗: 48hrs

reintubation within 48 hrs of extubation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali S. Hussain

Senior instructor

Aga Khan University

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