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临床试验/NCT05417256
NCT05417256Unknown不适用

A Prospective Randomized Trial Comparing the Application of Arndt and Tappa Endobronchial Blocker During Pediatric One Lung Ventilation

Istanbul University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年7月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
26
试验地点
1
主要终点
Time from laryngoscopy to placement of the bronchial blocker

研究概览

简要总结

This study aims to evaluate the efficacy and ease of placement of two different endobronchial blockers(Arndt and Tappa blocker) for pediatric patients undergoing thoracotomy. Time from laryngoscopy to successful insertion of the blocker by an experienced anaesthetist will be recorded and the difficulty of placement of the blocker will be assesed. We plan to evaluate the lung collapse and also observe the effect of two different bronchial blockers on patients' ventilation and oxygenation and adverse events such as desaturation, failed one lung ventilation.Our primary outcome is the time from laryngoscopy to successful insertion of the bronchial blocker by an experienced anaesthetist. Our secondary outcomes are effects of two different bronchial blockers on lung isolation score, ease of placement of the bronchial blocker, mechanical ventilation parameters (tidal volume, respiratory rate, peak airway pressure, plateau pressure, compliance), intraoperative blood gas analysis (paO2, pCO2, saO2, lac), frequency of malposition after successful blocker placement, surgical exposure and complications.

详细描述

Many techniques for one lung ventilation exist including the use of double-lumen tubes, endotracheal tubes and bronchial blockers. The choice of lung isolation technique depends on the age, the size of the patient, experience of the anaesthetist and type of the surgery. The use of double lumen tube for one lung ventilation is very common. However, it may be challenging and hazardous in some cases such as pediatric patients, patients with tracheostomy, difficult airway scenarios. Endobronchial blockers can be used for these cases. Bronchial blockers have high-volume,low-pressure balloons so they are less likely to cause damage to the airway mucosa while achieving a successful lung isolation. Arndt blocker has a low-pressure, high-volume balloon, a multiport airway adapter and a guide loop. On the other hand, Tappa bronchial blocker has an auto inflation balloon, and a high volume low pressure cuff. It also has 'Tappa angle' which is designed as per human anatomy which makes it easier to insert.

In our study, we aim to compare the efficacy and ease of placement of Arndt and Tappa blocker for pediatric one lung ventilation. Our primary outcome is the time from laryngoscopy to successful insertion of the bronchial blocker by an experienced anaesthetist. Secondary outcomes are effects of two different bronchial blockers on lung isolation score, ease of placement of the bronchial blocker, mechanical ventilation parameters (tidal volume, respiratory rate, peak airway pressure, plateau pressure, compliance), intraoperative blood gas analysis (paO2, pCO2, saO2, lac), frequency of malposition after successful blocker placement, surgical exposure and complications. The difficulty of placement of the blocker will be assesed by a 5-point scale (1:very easy, 5:impossible) and the lung collapse will be evaluated by using a 10-point scale (10: complete collapse).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients undergoing thoracic surgery
  • American Society of Anesthesiology Class 1-2-3

排除标准

  • Denial of patients or parents
  • Coagulopathy
  • With preexisting cardiac dysfunction
  • Wtih history of renal and/or hepatic dysfunction

结局指标

主要结局

Time from laryngoscopy to placement of the bronchial blocker

时间窗: Up to 30 minutes

Time from laryngoscopy to correct insertion of the bronchial blocker by an experienced anaesthetist will be recorded.

次要结局

  • Peak airway pressure(Up to 120 minutes)
  • Plateau pressure(Up to 120 minutes)
  • Lung collapse score(Up to 30 minutes)
  • Difficulty of placement(Up to 30 minutes)
  • Lactate(At 15 minutes after initiation of one lung ventilation.)
  • Frequency of malposition of the bronchial blocker(Up to the end of one lung ventilation intraoperatively.)
  • First mobilitisition time(Up to 24 hours)
  • Respiratory rate(Up to 120 minutes)
  • Partial pressure of oxygen(At 15 minutes after initiation of one lung ventilation.)
  • Tidal volume(Up to 120 minutes)
  • Partial pressure of carbon dioxide(At 15 minutes after initiation of one lung ventilation.)
  • Length of intensive care unit (ICU) stay(Up to 48 hours)
  • Compliance(Up to 120 minutes)
  • Length of hospital stay(Up to 1 week)

研究者

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

Meltem Savran Karadeniz

Associated Professor

Istanbul University

研究点 (1)

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