Nasal Intubation Using a Parker Flex-tip Endotracheal Tube With Posteriorly Facing Bevel Compared to a Nasal RAE Tube With Left Facing Bevel: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reduced Epistaxis
研究概览
简要总结
The purpose of this study is to determine the degree of epistaxis following nasal intubation with either a nasal endotracheal (RAE) tube with bevel facing left or Parker Flex-Tip endotracheal tube with bevel facing posteriorly
The investigators hypothesize that a Parker Flex-Tip endotracheal tube when inserted with bevel facing posteriorly during nasal intubation may reduce the incidence of epistaxis intra and post-operatively. The investigators propose that using this style of endotracheal tube improves patient safety and comfort and facilitates ease and success of nasal intubation.
详细描述
- Purpose
To investigate and describe the use of a Parker Flex-Tip endotracheal tube (ETT) with a posteriorly facing bevel for nasal intubation at Vancouver Coastal Health (VCH).
The investigators wish to demonstrate that a Parker Flex-Tip ETT with a posterior facing bevel eases ETT insertion and reduces epistaxis compared to a standard nasal RAE endotracheal tube (RAE ETT) currently used at VCH. The investigators propose that using this method improves performance and reduces complications of nasal intubation. 2. Hypothesis
Our hypotheses are:
- That a Parker Flex-Tip ETT with a posterior facing bevel may reduce the incidence of epistaxis
- That a Parker Flex-Tip ETT with a posterior facing bevel may allow the anesthesiologist to successfully nasal intubate with more ease and fewer attempts.
- That use of a Parker Flex-Tip ETT with a posterior facing bevel for nasal intubation is acceptable to anesthesiologists and patients
- Justification
Justification for developing a new technique Endonasal intubation is a widely performed technique that allows administration of anesthetic during oral, dental and maxillofacial surgeries while allowing unimpeded access to the surgical site. Nasal intubation poses several challenges not encountered in oropharyngeal intubation. These include advancing the endotracheal tube through the highly vascularized delicate mucosa of the nasal passage, past protruding turbinates, and maneuvering through the sharply angulated nasopharyx to access the trachea (Hall).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients
- •Over 16 years of age. The investigators definitely do not want to recruit anyone under age 16 yr
- •Undergoing an oral or maxillofacial surgery where nasal intubation would be appropriate for surgical anesthesia
- •General anesthesia and nasal intubation discussed and planned in the preoperative assessment clinic
- •ASA physical status I or II patients undergoing oral or maxillofacial surgery where nasal intubation would be appropriate for surgical anesthesia.
- •ASA Physical Status 1 - A normal healthy patient ASA Physical Status 2 - A patient with mild systemic disease ASA Physical Status 3 - A patient with severe systemic disease ASA Physical Status 4 - A patient with severe systemic disease that is a constant threat to life ASA Physical Status 5 - A moribund patient who is not expected to survive without the operation
排除标准
- •Patients not clinically amenable to general anesthesia
- •Documented anatomical deformities in the region of interest which includes nasal passages, internal nasal turbinates and nasopharynx. These structures will henceforth be called"region of interest."
- •History of trauma in the region of interest
- •Previous surgery in the region of interest
- •Coagulation defects
- •Anticoagulant medication other than Low Dose Aspirin
- •History of recurrent epistaxis
- •Age less than 16 years.
结局指标
主要结局
Reduced Epistaxis
时间窗: 5 minutes post intubation
The degree of epistaxis will be assessed by a blinded independent investigator 5 minutes post intubation, and along with ease of insertion, recorded. Quantity of epistaxis will be measured by swabbing the nasopharynx with a dry swab and measuring the difference in weight gain between the dry swab and blood soaked swab. Epistaxis will be evaluated based on the criteria established by Sugiyama et al. Four grades will be used: 1. No epistaxis, no blood observed on either the surface of the tube or the posterior pharyngeal wall 2. Mild epistaxis with blood apparent on the surface of the tube or posterior pharyngeal wall 3. Moderate epistaxis with pooling of blood on the posterior pharyngeal wall 4. Severe epistaxis with a large amount of blood in the pharynx impeding nasotracheal intubation and necessitating urgent orotracheal intubation
次要结局
- Number of attempts to insert tube(Immediately post intubation)
- Ease of tube insertion(Immediately post intubation)
- Post-operative patient nasal pain(Within 2 hours after extubation)