Determining the Effects of Foley Catheter-assisted Nasal Intubation on Nasal Bleeding in Adult Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Incidence of nasal bleeding
研究概览
简要总结
Nasal endotracheal intubation is a well-utilized and important endotracheal intubation route to allow good surgical access for operations involving the oral cavity. Despite its utility, there are potential complications from nasal endotracheal intubation including that of nasal bleeding, which in severe cases can impair the ability to complete the procedure.
The most accepted conventional practice to decrease bleeding associated with nasal endotracheal intubation is to warm the nasal endotracheal tube prior to insertion. However, this technique still yields high rates of nasal bleeding. In 1979, correspondence by MacKinnon and Harrison in Anaesthesia described the use of a flexible urinary catheter (Foley catheter) telescoped onto the endotracheal tube tip to aid atraumatic insertion of the tube. This also served to ensure the tube was not contaminated internally by nasal secretions or blood. This has been more rigorously studied in two RCTs looking at this technique in children, but there has been no similar study in adults.
This study aims to extend the evidence base of the use of this technique in adults. Our hypothesis is that the use of a flexible urinary catheter to telescopically aid nasal intubation will result in a significant decrease in the incidence and severity of nasal bleeding.
详细描述
The nasal endotracheal intubation technique is an important technique in the management of patients undergoing oral cavity surgery. While usually safe, there are known complications with this technique including nasopharyngeal trauma, epistaxis, bacteremia, endotracheal tube obstruction, retro-pharyngeal perforation, mucosal laceration, olfactory nerve injury, turbinate avulsion, and perforation of the pyriform fossa. There is also a case report of an accidental turbinectomy causing complete obstruction of the endotracheal tube from nasal endotracheal intubation.
As first described in 1979, via correspondence by MacKinnon and Harrison in Anaesthesia, the use of a flexible urinary catheter telescoped onto the endotracheal tube tip can aid atraumatic insertion of a nasal tube and ensure the tube is not contaminated internally by nasal secretions or blood.
This was studied in 2 RCTs in the pediatric population, and both showed a reduction in both the incidence and the severity of bleeding. To the best of our knowledge, there are no RCTs studying the use of a flexible urinary catheter to telescopically aid nasal intubation in the adult population. Thus, the aim of our study is to extend the evidence base for the use of this technique in the adult population. Our hypothesis is that the use of a flexible urinary catheter to telescopically aid nasal intubation will result in statistically and clinically significant reduction in nasal trauma as manifested by bleeding.
Reducing the side effect profile of nasal endotracheal intubation is important to reduce the adverse outcomes from this procedure. Given that the current conventional nasal intubation technique of prewarming the endotracheal tube has high incidence of morbidity i.e. of > 40% incidence of bleeding in adults, and that the flexible urinary catheter to telescopically aid nasal intubation has been shown to decrease the incidence of any bleeding in children when compared to prewarming of the tube, our study will provide further evidence to support regular and ongoing routine use of this technique in adults, which will decrease the morbidity of any patient undergoing this procedure in the future.
40 patients will be randomized to the intervention group (Foley-assisted nasal endotracheal intubation) and 40 patients will be randomized to the control group (standard nasal endotracheal intubation). After obtaining informed written consent and ensuring patients meet the inclusion criteria they will be allocated by the opening of one of the sealed randomization envelopes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patient will be blinded to group allocation as they are anesthetised during the intervention procedure.
The outcome assessor for the primary outcome (incidence of nasal bleeding) will also be blinded by inspecting the gauze swab for blood outside the patient's operating theatre.
The care provider and investigator are unable to be blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18
- •Scheduled to undergo an operation requiring nasotracheal intubation
排除标准
- •Latex allergy
- •Emergency surgery
- •High risk of aspiration
- •Anticipated or unanticipated difficult airway or bag mask ventilation
- •Morbid obesity (BMI >40)
- •Bleeding diathesis
- •Basal skull fracture
- •Previous deviated nasal septum surgery
- •Nasal polyps
结局指标
主要结局
Incidence of nasal bleeding
时间窗: 10 minutes (must be assessed prior to surgical start as this may cause additional bleeding)
Defined as the presence of blood on a folded stack of two 4x4 inch gauze swabs to the posterior oropharynx after the confirmation of successful nasotracheal intubation
次要结局
- Number of attempts at intubation(10 minutes)
- Severity of bleeding(10 minutes (must be assessed prior to surgical start as this may cause additional bleeding))
- Time to successful intubation(10 minutes)
- Incidence of requirement to suction blood from the oral cavity to facilitate intubation(10 minutes)
- Incidence of significant postop nasal bleeding(24 hours)
研究者
Eric You-Ten
Associate Professor Anesthesia
Mount Sinai Hospital, Canada