跳至主要内容
临床试验/CTRI/2024/11/077164
CTRI/2024/11/077164尚未招募不适用

Comparing the feasibility of ventilation with Novel nasal PAP device with conventional facemask in patients receiving general anaesthesia

AIIMSMangalagiri1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年1月1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
70
试验地点
1
主要终点
•To measure delta Vt (difference between set tidal volume and delivered tidal volume) using both Super NO2VA and conventional face mask

研究概览

简要总结

Mask ventilation is pivotal during general anaesthesia (GA) especially at induction, serving as the primary means of ventilation before securing a definitive airway. It encompasses two critical aspects: ensuring an airtight seal between the mask and the patient’s face to prevent gas leakage and maintaining an unobstructed upper airway. Despite this, patients are prone to airway obstruction. Using the 2-hand technique of mask ventilation and / or use of airway adjuncts such as oropharyngeal or nasopharyngeal airway might help relieve this obstruction.

Nasal mask ventilation directs inspired air through the nasal cavity, countering gravity’s influence on the soft palate and tongue, thereby maintaining upper airway patency. Consequently, direct nasal ventilation may offer improved ventilation efficacy and a more natural breathing pattern. Continuous positive airway pressure (CPAP), delivered via non-invasive ventilation masks not only prevent upper airway collapse but also are being used in the ICUs to ventilate patients and also pre-oxygenate before intubating the critically ill. Literature also suggests using the Rendell Becker Soucek mask and even paediatric facemasks can be used for nasal ventilation in children and edentulous patients but these do not provide positive airway pressure (PAP) and neither are specifically designed to give a perfect fit. Super NO2VATM is specifically designed for nasal ventilation and also has the advantage of providing positive pressure ventilation that would maintain patency of upper airway. This novel device has been introduced in the market for its use in obese patients with obstructive sleep apnoea who are posted for procedures under sedation. In this study, we are using this device for mask-ventilating patients at the start of general anaesthesia and trying to compare its effectiveness with that of the Conventional Facemask technique of ventilation

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of ASA I-III aged from 18 to 65 yrs are included in the study.

排除标准

  • Patients refusal Patients with anticipated difficult mask ventilation Patients with unanticipated difficult mask ventilation.

结局指标

主要结局

•To measure delta Vt (difference between set tidal volume and delivered tidal volume) using both Super NO2VA and conventional face mask

时间窗: T0-Baseline(Post Induction) | T1-15 secs | T2-30 secs | T3-45 secs | T4-60 secs

次要结局

  • •Change in the peak airway pressure (Paw)(•Change in SpO2)

研究者

发起方
AIIMSMangalagiri
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Muralidharan

All India Institute of Medical Sciences,Mangalagiri

研究点 (1)

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