跳至主要内容
临床试验/NCT07138079
NCT07138079尚未招募不适用

The Comparison of the Effectiveness of the Self-Pressurizing Air-Q Intubating Laryngeal Airway in Totally Edentulous and Dentate Geriatric Patients

Diskapi Yildirim Beyazit Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月18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
50
试验地点
1
主要终点
Measurement of oropharyngeal leak pressure (OLP)

研究概览

简要总结

In this study, we aim to investigate the clinical performance, efficacy, and associated complications of the Air-Q Intubating Laryngeal Airway in totally edentulous and dentate geriatric patients.

详细描述

In the elderly population, the prevalence of totally edentulous patients over the age of 65 exceeds 60%. With aging, parapharyngeal fat deposition increases and contributes to pharyngeal collapse in elderly patients . In elderly patients with total tooth loss, face mask ventilation is difficult because standard face masks do not fit well on edentulous faces. Additionally, during general anesthesia, loss of muscle tone, reduced oropharyngeal air space, posterior displacement of the tongue, and airway obstruction caused by the soft palate and epiglottis all make ventilation challenging . Structural changes in the airway, combined with age-related physiological alterations in respiration, may reduce oxygen saturation, blunt the hypoxic response, and increase the risk of postoperative respiratory complications. Due to age-related acquired changes in pharyngeal muscle activity, the likelihood of skeletal structural abnormalities such as retrognathia-often associated with difficult airways-has been proposed (2). Therefore, these age-related changes may influence the clinical performance of supraglottic airway devices (SADs).

Recently, SADs that do not require manual cuff inflation have gained popularity in various clinical settings due to their advantage of eliminating the need for manual cuff inflation and cuff pressure monitoring (5,6). The Air-Q is a supraglottic airway device that connects to an airway tube through a communication port, allowing self-pressurization of the cuff in response to airway pressure.

In this study, we aim to investigate the clinical performance, efficacy, and associated complications of the Air-Q Intubating Laryngeal Airway in totally edentulous and dentate geriatric patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65-90 year-old patients
  • Edentulous and gentate patients
  • American Society of Anesthesiologist Physical Status classification I-III,
  • Undergoing an elective operation under general anesthesia in our hospital

排除标准

  • Predicted difficult airway (Mallampati class 4, mouth opening < 3 cm, or thyromental distance < 6 cm)
  • Body mass index (BMI) > 40 kg/m2
  • Patients with a high risk of aspiration (e.g., history of gastrectomy, -gastroesophageal reflux disease, or hiatal hernia),
  • Unstable vital signs
  • Cervical spine problems, Respiratory complications (e.g. recent pneumonia).

结局指标

主要结局

Measurement of oropharyngeal leak pressure (OLP)

时间窗: One minute after successful LMA placement

One minute after successful LMA placement and fixation, oropharyngeal leak pressure

次要结局

  • fiberoptic view grading(3 minutes after induction of anesthesia)
  • maneuvers required for successful ventilation(3 minutes after induction of anesthesia)
  • ease of SGA placement(3 minutes after induction of anesthesia)
  • Air-Q insertion time(3 minutes after induction of anesthesia)

研究者

发起方
Diskapi Yildirim Beyazit Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Zeynep Koc

principal investigator

Diskapi Yildirim Beyazit Education and Research Hospital

研究点 (1)

Loading locations...

相似试验