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临床试验/CTRI/2025/02/081275
CTRI/2025/02/081275招募中1/2 期

Comparison of success rates of two techniques of extubation over supraglottic airway device (I-gel) in patients with unanticipated difficult airway

AIIMS1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
1/2 期
状态
招募中
发起方
AIIMS
入组人数
120
试验地点
1
主要终点
to compare the success rate of placement of I-gel (SGAD) using the Airway Exchange Catheter (AEC) technique with Asai’s technique in patients with an unanticipated difficult airway using brimacombe score

研究概览

简要总结

·       Preoperative anaesthetic fitness along with written informed consent will be obtained from all the participants by the principal investigator. Premedication in the form of Tablet Alprazolam 0.25 to 0.5 milligram and Tablet Pantoprazole 40 milligram will be administered the night before the surgery as per the institute protocol and patients will be asked to fast as per the standard recommendations. Observer 1 will allocate the participants to either of the group  as per the computer generated randomisation table The participant will remain blinded to the group allocation. In the operation theatre, after attaching standard monitoring including pulse oximetry electrocardiography and non-invasive blood pressure. Intravenous line will be secured in the non-dependent arm. Anaesthesia will be administered as per standard protocol by observer 2. The Intubation Difficulty Sore will be calculated after the successful placement of endotracheal tube. If the score is less than 5 the patient, observer 2 will proceed with the extubation strategy as per the randomisation table. At the end of the surgery observer 2will ensure adequate neuromuscular blockade and depth of anaesthesia before performing one of the two techniques of extubation. It will be ensured that patients will get 100% throughout the procedure. A weight-based formula as recommended by the manufacturer will be used to choose the appropriate sized Intersurgical gel. After confirming the placement of the Igel, the laryngeal alignment of the SGAD will be determined by passing an adult fibreoptic bronchoscope by observer 2**.**The fiberoptic bronchoscope will be passed through the airway tube to a position 1 cm beyond the aperture of the tube. The fiberoptic glottic view will be scored using an established scoring system Neuromuscular blockade will be reversed once the train of four count shows at least 3 twitches. The Intersurgical gel will be removed once the patient fulfils the subjective and objective criteria of extubation. Heart rate and blood pressure changes will be monitored while removing the Intersurgical gel every min up to 10 minutes after removal. Observer 1 will follow up with the patient for complications in the postoperative recovery unit.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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 belonging to the age group 18 to 65 years ASA PS I – III Intubation difficulty score (IDS) ≤ 5Scheduled for surgery under general anaesthesia.

排除标准

  • 未提供

结局指标

主要结局

to compare the success rate of placement of I-gel (SGAD) using the Airway Exchange Catheter (AEC) technique with Asai’s technique in patients with an unanticipated difficult airway using brimacombe score

时间窗: From insertion of I gel to appearance of capnograph

次要结局

  • Haemodynamic changes(Number of attempts)

研究者

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

Eeshwar M V

AIIMS Mangalagiri

研究点 (1)

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