Low Skill Fibreoptic Glottis View in Obese Patients: Ramp vs Supine Sniffing Air Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Feasibility study
研究概览
简要总结
Aims: The investigators are employing a feasibility study to determine whether fibreoptic view of the glottis (vocal cords) during low skill fibreoptic intubation (FOI) via a laryngeal mask airway (LMA) in obese and severely obese patients is appropriate and feasible for future full-scale research. Obese, and severely and morbidly patients in Asia are classed as body mass index (BMI) of ≥ 30, ≥35 and ≥40 kg/m2, respectively.
详细描述
Aims: The investigators are employing a feasibility study to determine whether fibreoptic view of the glottis (vocal cords) during low skill fibreoptic intubation (FOI) via a laryngeal mask airway (LMA) in obese and severely obese patients is appropriate and feasible for future full-scale research. Obese, and severely and morbidly patients in Asia are classed as body mass index (BMI) of ≥ 30, ≥35 and ≥40 kg/m2, respectively.
Hypothesis: The glottis view during low skill FOI in obese and severely obese patients (BMI ≥30, and BMI ≥35 <40 kg/m2) is better in the ramp than in the standard supine 'sniffing air' position. Low skill FOI is a term for FOI via an LMA.
Methodology: As a feasibility study, the investigators will recruit 18 adult patients scheduled for elective surgery in obese and severely obese patients requiring tracheal intubation. A non-randomized cross over design in selected. The investigators will assess acceptability, implementation and practicality of such a study and also set criteria for success of this feasibility study.
Importance of proposed research: Obese patients present many anaesthetic challenges. The ramp position facilitates easier tracheal intubation and prolongs apnoea time. In cases of failed intubation, guidelines recommend insertion of an LMA to faciliate ventilation and oxygenation, allowing the option of low skill FOI to secure the airway. It may be performed in unanticipated difficult airway ('rescue' intubation after failed intubation by conventional techniques) and so may decrease patient morbidity and mortality. There is a knowledge gap regarding whether the glottis view during low skill FOI is superior in the ramp or standard supine sniffing position. It will help determine whether the study methodology and protocol needs modification and assess what changes may occur, before implementing a full-scale study. This will help form recommendations for future guidelines in difficult airway management.
Primary outcome is to measure feasibility of this study. The areas of focus addressed by this study are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Images are reviewed by two senior anaesthetists who is not directly involved in the study.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •obese and severely obese patients (BMI ≥30, and ≥35 but <40 kg/m2, respectively) undergoing elective bsurgery under general anaesthesia who require endotracheal intubation.
排除标准
- •Morbidly obese patients (BMI ≥40 kg/m2)
- •Patients with history of previous difficult endotracheal intubation
- •Patients with two or more predictors of difficult face or laryngeal mask ventilation, or difficult intubation or the combination of both
- •Mallamapatti score III-IV
- •Interdental distance <3cm
- •Thyromental distance <6cm
- •Moderate to severe limitation of neck movement
- •Previous head and neck radiotherapy or surgery
- •Supraglottic lesion
- •Patients with loose teeth
- •Patients with ASA grade III (other than due to obesity) and grade IV are excluded from the study
- •Patients needing a rapid sequence induction for rapid securement of the airway e.g. patients with symptoms of reflux (>1 episode per week), not starved as per standard nil by mouth guidelines, hiatus hernia, previous gastric surgery
- •Pregnant women
- •Patients below the age of 21 years old
- •Patients unfit to give consent
研究组 & 干预措施
LSFOI (Ramped)
LSFOI (Ramped)
干预措施: Ramped position (Procedure)
LSFOI (Ramped)
LSFOI (Ramped)
干预措施: Supine position (Procedure)
LSFOI (Supine)
LSFOI (Supine)
干预措施: Ramped position (Procedure)
LSFOI (Supine)
LSFOI (Supine)
干预措施: Supine position (Procedure)
结局指标
主要结局
Feasibility study
时间窗: 6 months
patient recruitment rate and ability to complete the study
次要结局
- Fibreoptic intubation times(6 months)
- Any complications(6 months)
- Airway manoeuvres to optimize glottis view(6 months)
- Positioning challenges(6 months)
- LMA insertion times(6 months)
- Success of LMA insertion rate(6 months)