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临床试验/CTRI/2020/03/023887
CTRI/2020/03/023887尚未招募不适用

Use of Proseal laryngeal mask airway with pressure controlled ventilation with positive end expiratory pressure in improving oxygenation in paediatric population

Department of Anaesthesiology and Intensive Care1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Partial pressure of O2 (PaO2)

研究概览

简要总结

Endotracheal intubation or bag-and-mask ventilation have been the mainstays of airway management for several decades. In 1983, this changed with the invention of the laryngeal mask airway (LMA) which provided ease of placement and hands-free maintenance along with a relatively secure airway. LMA is increasingly being used in all patient population including children and has been found to be very safe and efficacious in various studies.

In the paediatric age group, the outward recoil of the chest wall is low, but the inward lung recoil is similar to that of a young adult. As the Functional Residual Capacity (FRC) is the lung volume at which the outward recoil of the chest wall exactly balances that of the inward recoil of the lungs, this leads to a reduced FRC in children. In awake state, the FRC is maintained by mechanisms such as active diaphragmatic and intercostal expiratory tone, but under general anaesthesia the closing volume tends to increase and the functional residual capacity decreases resulting in atelectasis and subsequent decreased arterial oxygenation.

The application of adequate tidal volumes and a positive end-expiratory pressure (PEEP) play an important role in counteracting this airway closure and atelectasis in paediatric patients under general anaesthesia. This is usually achieved by using an endotracheal tube. However the ProSeal LMA (PLMA) has been shown to form a more effective seal than the Classic LMA and can be used to deliver PEEP which may improve gas exchange in children.5.6

There are few studies evaluating the use of PEEP with a supraglottic airway device in the paediatric age group in an attempt to minimise small airway closure. Hence we thought it worthwhile to compare the use of PLMA for pressure controlled ventilation with and without PEEP for improving oxygenation in paediatric patients.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • 1.American society of anesthesiologist (ASA) physical status I 2.Patients undergoing surgical procedures permitting the use of supraglottic devices.

排除标准

  • 1.Any upper or lower respiratory infections, asthma, cystic fibrosis etc.
  • 2.Patient at risk of aspiration.
  • 3.Patient with anticipated difficult airway.
  • 4.Patients with reduced lung compliance, obesity or those with musculoskeletal disorders.
  • 5.Patient undergoing spine and thoracoabdominal surgeries.
  • 6.Patients requiring surgeries in prone or lateral positions.

结局指标

主要结局

Partial pressure of O2 (PaO2)

时间窗: 30 mins after the institution of positive end expiratory pressure

次要结局

  • Partial pressure of CO2 (PaCO2)(30 mins after the institution of positive end expiratory pressure)
  • Any co-relation between the fibre optic grading and the Partial pressure of O2 (PaO2) levels(30 mins after the institution of positive end expiratory pressure)
  • Arterial blood pH(30 mins after the institution of positive end expiratory pressure)
  • Oropharyngeal seal pressure(After successful placement of the Proseal LMA.)

研究者

发起方
Department of Anaesthesiology and Intensive Care
申办方类型
Government medical college

研究点 (1)

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