跳至主要内容
临床试验/CTRI/2024/05/068087
CTRI/2024/05/068087尚未招募不适用

Comparison of flexible bronchoscope guided nasotracheal intubation with videolaryngoscopic nasotracheal intubation after induction of general anesthesia in patients with normal airway: A single-blinded pilot randomised controlled trial

Mahamana Pandit Madan Mohan Malviya Cancer Centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月10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
Ratio of successful nasotracheal intubation by FB compared to videolaryngoscopic nasotracheal intubation

研究概览

简要总结

Endotracheal intubation is a crucial step in patients undergoing surgery under general anesthesia. There are many ways to intubate the trachea, the commonest of which include direct laryngoscopy, video laryngoscopy and flexible bronchoscope (FB) guided intubation. Awake FB-guided intubation is the gold standard and preferred way to secure the trachea in cases of anticipated difficult airway. However, FB-guided intubation after general anesthesia is not frequently chosen by anesthesiologists in day-to-day practice although its use is mentioned in unanticipated difficult airway guideline. [1]

 Under general anesthesia, muscle tone is reduced which makes upper airway structures collapse and fall towards the posterior pharyngeal wall. [2-3] This may make the airway potentially difficult for FB-guided intubation after induction of general anesthesia. In a previous study, where FB-guided orotracheal intubation after general anesthesia was evaluated, the aforementioned problem was prevented by applying jaw thrust and lingual traction. [4] Nasotracheal intubation is a commonly performed procedure to secure the airway during surgeries involving the oral cavity. It is usually done by direct or video laryngoscopy which carries the added risk of trauma related to direct instrumentation. Blind introduction of an endotracheal tube through the nostrils can lead to the avulsion of nasal spur/ polyp or mechanical obstruction. Using a FB for nasotracheal intubation helps in the evaluation of the passage prior to the introduction of the endotracheal tube and can avert complications associated with the blind introduction.

 We hypothesize that in an airway not anticipated to be difficult, FB-guided nasotracheal intubation after induction of general anesthesia will be better compared to the videolaryngoscopic intubation in terms of improved success rate, a lesser degree of airway trauma and lesser added instrumentation. FB-guided nasotracheal intubation may also be associated with a lesser surge in blood pressure and heart rate usually associated with laryngoscopy and intubation. Though airway collapse may interfere with the advancement of the bronchoscope, choosing the nasotracheal route might help in better alignment of airway axes leading to a higher success rate of endotracheal intubation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to participate and sign the informed consent form
  • Age-18 years to 65 years
  • ASA 1 and 2 patients
  • Both sexes
  • Inter-incisor distance greater than three fingers
  • Thyromental distance ≥ 6.5 cm Normal range of neck movements.
  • Patients posted for surgery who require nasotracheal intubation.

排除标准

  • Patients with an anticipated difficult airway.
  • Patients having contraindications for nasotracheal intubation
  • Pregnant patients.
  • Mentally challenged patients unable to understand and give informed risk consent.

结局指标

主要结局

Ratio of successful nasotracheal intubation by FB compared to videolaryngoscopic nasotracheal intubation

时间窗: following induction of general anesthesia

次要结局

  • 1. Time requirement for the successful intubation(2. Number of attempts required for successful intubation)

研究者

发起方
Mahamana Pandit Madan Mohan Malviya Cancer Centre
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sandipan Banerjee

Mahamana Pandit Madan Mohan Malviya Cancer Centre

研究点 (1)

Loading locations...

相似试验