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临床试验/NCT05937516
NCT05937516已完成不适用

Guidewire Use for Nasopharyngeal Passage in Pediatric Nasotracheal Intubation: A Randomized Prospective Study

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年3月15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
90
试验地点
2
主要终点
Presence of blood in oropharynx or on the endotracheal tube

研究概览

简要总结

During nasotracheal intubation, nasopharyngeal trauma and associated bleeding may occur. The investigators think that some of this bleeding is due to trauma to the posterior wall of the nasopharynx. The investigators designed this study, thinking that if nasopharyngeal posterior wall trauma can be prevented, some of these bleedings can be prevented.

详细描述

Nasotracheal intubation (NTI) is a frequently used airway management method in pedodontic dental treatments performed under general anesthesia. However, nasopharyngeal trauma and associated bleeding are common during conventional NTI. In this study, the investigators aimed to examine the effect of angling the end of the endotracheal tube (ETT) by placing a guide wire inside the ETT on nasopharyngeal bleeding.

The patients included in the study were randomized into two groups. In the control group (Group C), NTI will be done conventionally. In the study group (Group S), a guide wire will be inserted into the ETT before intubation and angled 100-120 degrees to the distal end (in the shape of a hockey stick). The angulation will not be sharp but slightly curved and the apex of the angulation will be 2.5-3 cm proximal from the distal end. The ETT will be positioned perpendicular to the face and inserted into the nostril. After the angled part of the ETT passes through the nostrils, it will be directed to caudally according to the angle given to the tip of the ETT. Meanwhile, the ETT will be moved as a whole to prevent the ETT tip from contacting the posterior wall of the nasopharynx. When the ETT tip reaches the oropharynx, the guidewire will be removed and the rest of the intubation will be completed as in the conventional method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

After intubation was completed, bleeding was evaluated by the other investigator who did not know the patient's group.

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 2-12 years old
  • American Society of Anesthesiologists I-III
  • Patients with elective dental surgery
  • Patients whose parents have accepted informed consent forms
  • Patients without previous nasopharyngeal anomalies
  • Patients without previous nasopharyngeal surgeries
  • Patients without upper airway infections

排除标准

  • Under 2 or over 12 years old
  • Emergency surgeries
  • Patients whose parents have not accepted informed consent forms
  • Patients with previous nasopharyngeal anomalies
  • Patients with previous nasopharyngeal surgeries
  • Patients with upper airway infections

结局指标

主要结局

Presence of blood in oropharynx or on the endotracheal tube

时间窗: In the fifth minute after intubation

The presence of blood in the oropharynx or endotracheal tube will be defined by assessing it on a scale. (0 = no blood, 2 = mild, that is, dye-like blood on the endotracheal tube, 3 = severe, that is, obvious blood in the oropharynx).

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

Asım Esen

Assistant Professor ASIM ESEN

Bezmialem Vakif University

研究点 (2)

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