跳至主要内容
临床试验/CTRI/2025/01/078880
CTRI/2025/01/078880已完成不适用

Comparison of LMA Blockbuster and LMA Proseal for controlled ventilation in paediatric patients.

Postgraduate Institute of medical sciences Rohtak1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年2月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Comparison of Time of insertion, ease of insertion, number of attempts, Oropharyngeal leak pressure, Fiberoptic view scoring, Postoperative complications and hemodynamic monitoring after insertion of LMA Blockbuster and LMA Proseal.

研究概览

简要总结

Title: comparison of LMA Blockbuster and LMA Proseal for controlled ventilation in paediatric patients

70 patients (35 in each group) of age group 5 years to 12 years with Mallampatti grade 1 or 2 belonging to American society of Anaesthesiologists (ASA) category I or II, undergoing elective surgery under general anaesthesia. Oropharyngeal leak pressure, time of insertion, number of attempts, ease of insertion, fiberoptic view scoring, Blood/secretion on device will be compared.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Patients with age group 5 years to 12 years with Mallampatti grade (MPG) 1 or 2 belonging to American society of Anaesthesiologists (ASA) I or II, undergoing elective surgery under general anaesthesia.

排除标准

  • Difficult airway, BMI more than 95th percentile for the age, History of recent airway infection, Risk or history of Aspiration syndrome, Refusal to consent by parents/guardians will be excluded.

结局指标

主要结局

Comparison of Time of insertion, ease of insertion, number of attempts, Oropharyngeal leak pressure, Fiberoptic view scoring, Postoperative complications and hemodynamic monitoring after insertion of LMA Blockbuster and LMA Proseal.

时间窗: Baseline: | Collect baseline measures (e.g., heart rate, oxygen saturation, blood pressure and end-tidal carbon dioxide). | Immediately after insertion:- Time of insertion, Ease of insertion, number of attempts, Fiberoptic view scoring and Oropharyngeal leak pressure. | Postoperative complications like blood stains on device, sore throat, hoarseness of voice.

次要结局

  • Number of attempts, Time of insertion, ease of insertion, fiberoptic view scoring, Oropharyngeal leak pressure, postoperative complications,(hemodynamic monitoring)

研究者

发起方
Postgraduate Institute of medical sciences Rohtak
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Vandna Arora

Department of Anaesthesia and critical care, Postgraduate Institute of medical sciences, Rohtak

研究点 (1)

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