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临床试验/CTRI/2025/07/091135
CTRI/2025/07/091135尚未招募2/3 期

Comparison of neutral position versus Lateral Head Rotation on Gastric Insufflation during Facemask Ventilation in Adults undergoing General Anaesthesia: A Randomized Controlled Trial

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年8月14日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
180
试验地点
1
主要终点
To compare the incidence of gastric insufflation as evidenced by comet-tail artefacts using ultrasonography during facemask ventilation between the lateral head rotation and the neutral head position.

研究概览

简要总结

Facemask ventilation is a fundamental airway management skill that is vital for ensuring adequate oxygenation and ventilation during resuscitation and the induction of general anaesthesia. Facemask ventilation in an obstructed airway requires peak inspiratory pressures between 25 to 30 cm H2O, which may cause gastric insufflation in 40-60 percentage of population. The resulting rise in intra-gastric pressure can result in complications such as regurgitation of gastric contents leading to aspiration pneumonia, postoperative nausea and vomiting, reduced lung compliance and cardiac output. Studies have shown that 45 degree lateral head rotation can be an effective alternative to the neutral position for enhancing mask ventilation when airway obstruction occurs. Lateral head rotation significantly enlarges the upper airway diameter in the neck, increases the cross-sectional area in the retroglossal region, and shifts soft tissue away from the submandibular space, thereby reducing upper airway obstruction. While previous studies have examined the effects of various levels of peak inspiratory pressure on gastric insufflation in the neutral head position, the influence of lateral head rotation on gastric insufflation has not yet been investigated. With this knowledge, we expect lateral head rotation to effectively relieve airway obstruction, reduce peak inspiratory pressures, and minimize gastric insufflation during facemask ventilation in apneic adults.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator 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 undergoing elective surgeries under general anaesthesia requiring endotracheal intubation
  • American Society of Anesthesiologists physical status I and II
  • Body mass index of 18–30 kilogram per square metre.

排除标准

  • Patient refusal
  • Anticipated difficult airway
  • High risk for aspiration
  • Pregnant women
  • Oropharyngeal or facial pathology
  • Known respiratory disease.

结局指标

主要结局

To compare the incidence of gastric insufflation as evidenced by comet-tail artefacts using ultrasonography during facemask ventilation between the lateral head rotation and the neutral head position.

时间窗: During the intervention

次要结局

  • To compare the gastric antral cross-sectional area using ultrasonography after facemask ventilation(Baseline & after the intervention)
  • To compare the peak inspiratory pressures for achieving expiratory tidal volume of 8 ml/kg of predicted body weight(During the intervention)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Suryanarayanan S

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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