跳至主要内容
临床试验/NCT03779984
NCT03779984已完成不适用

Use of a Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients: A Prospective Randomized Controlled Trial

University of Texas Southwestern Medical Center4 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2019年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
4
主要终点
The Number of Participants With Nasal Bleeding

研究概览

简要总结

This study was designed to compare the effectiveness of using a red-rubber catheter versus standard, direct insertion of a thermosoftened, lubricated nasal endotracheal tube into the naris to facilitate nasotracheal intubation in adults. This study will assess if the red-rubber catheter method leads to lower incidence and severity of epistaxis, faster time to intubation, and higher patient satisfaction compared to the current standard of care.

详细描述

The study population for this prospective randomized controlled trial will consist of male and female adult subjects over the age of 18 having surgery requiring nasal tracheal intubation (NTI). Subjects will be randomized to either the Red Rubber Catheter (RRC) group or control group.

Oxymetazoline nasal spray will be administered with 1 spray per nostril preoperatively. Premedication with glycopyrrolate 0.2 mg and benzodiazepine at discretion of provider will be given preoperatively. Subjects will then be brought into the operating room and placed on all standard ASA monitors (BP cuff, EKG, pulse oximetry). One spray of oxymetazoline per nostril will again be administered. Standard preoxygenation will be used with a face mask and 100% O2. After induction of anesthesia, provider will confirm mask ventilation and 1 more spray of oxymetazoline will be administered per nostril. Intubation will first be attempted via a naris. Size 6.5 nasotracheal RAE tubes (Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, manufactured by Coviden llc, Mansfield, MA 02048) will be used in female patients and size 7.5 in males. The tubes will be thermosoftened by allowing them to sit in warm saline prior to use. Water-based lubrication will be used for dilation and intubation. Time from insertion of RRC or NETT into nasal passage to first recording of end-tidal CO2 will be recorded. Direct video laryngoscopy will be used to facilitate placement of the nasotracheal RAE tube.

Five minutes after intubation, a non-collaborating anesthesia provider blinded to the method of intubation will grade the severity of bleeding by performing direct video laryngoscopy, inspecting the posterior pharynx and using a scale -

  1. No epistaxis (no blood observed on either the surface of the tube or the posterior pharyngeal wall);
  2. Mild epistaxis (blood apparent on the surface of the tube or posterior pharyngeal wall);
  3. Moderate epistaxis (pooling of blood on the posterior pharyngeal wall);
  4. Severe epistaxis (a large amount of blood in the pharynx impeding nasotracheal intubation-before the epistaxis assessor enters the operating room, requiring suction for intubation or necessitating urgent orotracheal intubation.)

Degree of patient satisfaction and nasal pain on the side of intubation will be rated on a numerical rating scale at 30 and 60 minutes in the post-anesthesia care unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Outcome accessor and participants are blinded.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18, male and female
  • Subjects undergoing surgery requiring NTI

排除标准

  • History of anticoagulant use or coagulopathy
  • History of latex allergy
  • History of difficult airway
  • Anticipated difficult airway requiring awake intubation
  • Abnormal anatomy of the nasal passage (due to prior trauma, surgery, congenital defects, etc.) or basilar skull fracture
  • Patients unable to be placed in the sniffing position
  • Morbid obesity with BMI > 40
  • Pregnancy

结局指标

主要结局

The Number of Participants With Nasal Bleeding

时间窗: Within 5 minutes following the nasal tracheal intubation

The number of participants with nasal bleeding within 5 minutes following nasal tube placement.

次要结局

  • The Number of Participants With Severe Epistaxis(Within 5 minutes following nasal intubation)

研究者

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

David W Mercier

Professor

University of Texas Southwestern Medical Center

研究点 (4)

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