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临床试验/NCT02502461
NCT02502461已完成不适用

Tracheal Palpation of Sliding Cuff to Assess Endotracheal Tube Location in Trachea - A Randomized Controlled Trial

University of Saskatchewan2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Sore Throat

研究概览

简要总结

Correct endotracheal tube (ETT) placement is important. Proper ETT position is achieved when the distal tip is in mid-trachea with the head in neutral alignment. Unrecognized tube misplacement is an uncommon but significant cause of hypoxemia and death during general anesthesia as well as in the care of critically ill patients.

Hypotheses: A specific manoeuvre to palpate the inflated ETT cuff, with fingers anterior to the trachea, moving the ETT caudally then rostrally following intubation, will enable correct depth placement of the tip of the ETT within the trachea (more than 2.5cm above the carina with cuff below the vocal cords) more frequently than routine care. This will not cause tissue damage as measured by sore throat.

详细描述

Introduction:

Correct endotracheal tube (ETT) placement is important. Proper ETT position is achieved when the distal tip is in mid-trachea with the head in neutral alignment. Unrecognized tube misplacement is an uncommon but significant cause of hypoxemia and death during general anesthesia as well as in the care of critically ill patients.

Three types of malpositioning can occur: one outside the trachea (esophageal), and two within the trachea: too shallow, or too deep (endobronchial). Esophageal intubation results in hypoxemia and inflation of the stomach. Too-shallow placement of the ETT can result in inadvertent extubation, especially with manipulation of head and neck. Endobronchial intubation occurs when the ETT is advanced into a mainstem bronchus, which results in hypoxia and the potential for barotrauma in the hyperventilated lung.

Confirmation of correct ETT placement is currently performed by several methods. In the operating room, simple measurement of the length of the tube at the corner of the mouth using marks on the ETT is the usual method (Measurement Method: MM; 21cm at the teeth for women; 23cm for men). It is simple and rapid, but not reliable. One study attempted to improve on this by using anatomical landmarks to determine ETT tube length as measured at the mouth. It enabled a reduction in the incidence of too-deep placement of the ETT from 58.8% to 24%. Measurement of these landmarks is sufficiently inconvenient that it is not widely practised.

Cuff ballottement at the level of the suprasternal notch is a technique that has been studied with cuffed tubes in adults. Ballottement involves moving the fingers in a radial axis of the ETT in order to compress and release the cuff, while feeling and watching the corresponding movement of the pilot balloon. Studies to date of ballottement do not comment on its ability to prevent esophageal intubation.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participant is fully anesthetized. 1)Depth of ETT not known or knowable until after objective measurement. 2) Pain assessor unaware of participant group.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) Class I and II patients
  • ≥18 years of age
  • undergoing elective surgical procedures in the Saskatoon acute care hospitals of the Saskatoon Health Region
  • requiring endotracheal intubation as a component of the anesthetic plan.

排除标准

  • those who are physiologically unstable
  • when there is urgency to proceed with surgery
  • patients requiring rapid sequence induction
  • those with respiratory distress
  • those for whom the attending anaesthesiologist feels it would compromise safety for any reason.

结局指标

主要结局

Sore Throat

时间窗: when patient awake (within 24 hours of intubation)

Surrogate measure of tissue damage from moving the tube with cuff inflated = soreness of throat on an 11-point verbal pain scale, with 0 = no pain, and 10 the worst pain imaginable.

次要结局

  • Number of Participants With Correct Depth of Endotracheal Tube in Trachea,(immediate (within 5minutes of intubation).)

研究者

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

William McKay

Professor of Anesthesia

University of Saskatchewan

研究点 (2)

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