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临床试验/CTRI/2024/03/064296
CTRI/2024/03/064296尚未招募2/3 期

Effect of Different Operating Table Height on Successful Insertion of Supraglottic Airway Device in Pediatric Patients Undergoing Elective Surgery Under General Anaesthesia

ABVIMS and Dr RML hospital1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2024年3月25日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
182
试验地点
1
主要终点
Appearance of EtCO2 waveform on capnography.

研究概览

简要总结

General anaesthesia is a state of deep sleep or unconsciousness, during which the patient has no awareness or sensation. Airway management is a crucial period during the administration of general anaesthesia. One of the ways of maintenance of airway involves placement of a supraglottic airway device that sits above the vocal cords, which allows for adequate delivery of oxygen and anaesthetic gases to lungs.

Supra Glottic Airway devices have become a standard management, filling a niche between the face mask and tracheal tube in terms of both anatomical position and degree of invasiveness. 2nd generation supraglottic airway device with gastric port stands out as the latest, most intricate, and potentially, the most impactful among specialized laryngeal mask devices. The primary objective in its design was to create a laryngeal mask with enhanced ventilatory properties while also offering safeguards against regurgitation and gastric insufflation. The key innovations include a modified cuff and a drainage tube. 2nd generation supraglottic airway device functions as a double mask, establishing two end-to-end connections: one with the respiratory tract and the other with the gastrointestinal tract.

2nd generation supraglottic airway device wit gastric port is used commonly as it provides numerous advantages when compared to endotracheal intubation, including superior haemodynamic stability, less airway trauma, superior patients comfort, and offers protection from barotrauma with smooth awakening of the patient.1 The success rate of SAD insertion ranges from 77% to 90%, and suboptimal positioning occurs in 30–66% of cases.2 Airway morbidity still occurs even with the apparent proper insertion of SAD3. As such, the SAD should be inserted and placed in an optimal position to minimize complications and allow for maximal functionality.

Operating table height can influence task performance and physical/mental workload of anaesthesiologist 4. The physical effort required for bag and mask ventilation and endotracheal intubation is influenced by the positioning of the patient and the height of the operating table. This positioning relies on maintaining an unobstructed linear path between the larynx and the observer’s eye. Achieving this necessitates precise patient positioning, which, in turn, depends on employing various maneuvers and adjusting the height of the operating table. Incorrect body posture can have detrimental effects on the health of an anaesthetist, potentially leading to back problems.

Children have been the earliest patrons of anaesthesiology from its earliest clinical applications of surgical anaesthesia. SAD is widely used in pediatric anaesthesia to maintain airway during surgery.

To the best of our knowledge, no similar study was conducted on investigating the optimal table height for SAD placement in pediatric population. So, we propose a study to compare two operating table heights to find out which could allow for a successful insertion of SAD at the first attempt in pediatric population.

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

入选标准

  • ASA GRADE 1 AND 2.

排除标准

  • Trauma, Tumor or deformity of upper airway Patient with thyroid and neck swelling Fracture and deformity of cervical spine Past history of difficult intubation.

结局指标

主要结局

Appearance of EtCO2 waveform on capnography.

时间窗: 0 minute, 3 minute and 5 minute

delivery of set tidal volume

时间窗: 0 minute, 3 minute and 5 minute

successful gastric tube insertion through gastric port of supraglottic airway device

时间窗: 0 minute, 3 minute and 5 minute

次要结局

  • The duration of Insertion which will be measured from the placement of SAD at oral orifice to the appearance of EtCO2 waveform.(0 second 30 seconds & 1 minute)

研究者

发起方
ABVIMS and Dr RML hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Touseef Khan

ABVIMS and Dr RML Hospital

研究点 (1)

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