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临床试验/NCT04045899
NCT04045899已完成不适用

"A Randomized Controlled Study Comparing ProSeal Laryngeal Mask Airway, Air-Q LMA and Ambu AuraGain in Mechanically Ventilated Patients"

Dr.Mahak Mehta0 个研究点目标入组 150 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
主要终点
Insertion Time of device measured in seconds

研究概览

简要总结

The present study entitled, "A Randomized Controlled Study Comparing ProSeal Laryngeal Mask Airway, Air-Q LMA and Ambu AuraGain in mechanically ventilated patients." was conducted in during the period Nov 2016 - Aug 2018.

The Aim of the study was to compare the clinical performance of ProSeal-LMA (P-LMA) ,Air-Q and Ambu AuraGain in terms of efficacy and safety in anaesthetized and paralyzed patients on mechanical ventilation undergoing elective surgical procedures.

Objective was to study the three supraglottic devices with respect to following parameters:-number of insertion attempts and overall success rate, ease of insertion of device, time taken for placement of device, airway sealing pressure, glottic view, number of attempts of gastric tube placement, hemodynamic parameters: heart rate and mean arterial pressure: pre-insertion and 0,1,3,5 and 10 minutes post insertion and complications noted if any: blood staining of device and tongue, lip and dental trauma, laryngospasm ,sore throat, dysphagia, hoarseness of voice.

It was a randomized prospective single blind comparative study comprised of 150 ASA I - II patients, aged 18-65 years of either sex who weighed between 40 to 60 kg scheduled for elective surgical procedure of duration not more than 90 mins. After a thorough pre-anaesthetic check-up, informed written consent was obtained and the patients were randomized into 3 groups of 50 patients each as Group P(Proseal), Group Q (Air Q) and Group A (AuraGain) by computer generated randomization sequence.

详细描述

In this study PLMA, Air-Q® and Ambu AuraGain were compared undergoing elective surgeries under general anaesthesia. Primary outcome measure was insertion time. Airway sealing pressure,ease of insertion, number of attempts,overall success rate, glottis view,number of attempts of gastric tube placement , hemodynamic parameters and complications were also compared.

After approval from the institutional ethical committee, 150 patients were studied in a randomised prospective study, designed to compare PLMA , Air-Q® and Ambu AuraGain .The period of the study was from nov 2016 to aug 2018. This study was conducted according to Good Clinical Practice standards and the Helsinki Declaration.

The American Society of Anesthesiologists (ASA) physical status I and II patients, between 18-65 years of age, weighing from 40 to 60 kg of either sex, undergoing elective surgical procedures of duration not more than 90 minutes were selected for the study. The exclusion criteria included patients with anticipated difficult airway (mouth opening of <2 finger, Mallampati Score 4, limited neck extension, history of previous difficult intubation), upper respiratory tract infections,airway related conditions such as trismus, trauma or mass, cervical spine disease, obese with body mass index (BMI) ≥25kg/m2 ,pregnant females, patients at risk of aspiration (full stomach, hiatus hernia, gastro-oesophageal reflux disease, emergency surgery)and laparoscopic surgeries. Neck movement was assessed as Class: I-No reduction in movement, II-1/3rd reduction, III-2/3rd reduction, IV-Complete reduction.

Following detailed pre-anaesthetic check-up, informed written consent was obtained from all patients fulfilling the required criteria.Patients were randomly allocated into three groups namely Group P(ProSeal,n=50) ,Group Q (Air-Q®, n = 50) and Group A (AuraGain™, n = 50) using computer-generated randomisation sequence. Participants were assigned to specific groups by the operating room nurse in charge.

After attaching the standard monitors(ASA recommended), patients were pre-medicated with injection midazolam 0.05 mg/kg, glycopyrrolate 0.2 mg, dexamethasone 4 mg and nalbuphine 0.02mg/kg intravenously. All patients were pre-oxygenated for 3 min, and anaesthesia was induced with injection propofol 2 mg/kg. Injection vecuronium 0.1 mg/kg was given for neuromuscular blockade.

研究设计

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

入排标准

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

入选标准

  • American Society of Anaesthesiologists (ASA) class I/II.
  • Age 18-65 years of either sex.
  • Weight between 40-60 kg of either sex.
  • Elective Surgical procedures of duration not more than 90 minutes with no need for endotracheal intubation.

排除标准

  • • Patients with anticipated difficult airway(Mouth opening of <2 finger, Mallampati class 4,limited neck extension, history of previous difficult intubation).
  • Restricted mouth opening
  • Pregnant females
  • Cervical spine disease
  • Obese with body mass index ≥25kg/m
  • Patients with upper respiratory tract infections.
  • Patients at the risk of gastroesophageal regurgitation (eg hiatus hernia,sepsis, Diabetes Mellitus,obesity,pregnancy or a history of upper gastrointestinal surgery)
  • Laparoscopic surgeries
  • Patients with airway related conditions such as trismus,trauma or mass.

研究组 & 干预措施

ProSeal Laryngeal Mask Airway Group

Active Comparator

ProSeal LMA was inserted in 50 patients

干预措施: Proseal LMA (Device)

Air-Q LMA Group

Experimental

Air-Q LMA was inserted in 50 patients

干预措施: Air-Q LMA (Device)

Ambu AuraGain LMA Group

Experimental

Ambu AuraGain was inserted in 50 patients

干预措施: Ambu AuraGain LMA (Device)

结局指标

主要结局

Insertion Time of device measured in seconds

时间窗: 10 minutes

Time of insertion: The time interval(seconds) elapsed from insertion of SAD between the dental arches until the confirmation of successful ventilation determined by chest wall movement,auscultation of breath sounds and square wave capnographic curves and no oropharyngeal leak with peak airway pressure \>/= 20 cm of H2O.The time will be measured with the help of stop watch.

次要结局

  • Glottic View through the device measured in %(10 minutes)
  • Number of attempts of gastric tube placement(20 minutes)
  • Number of attempts of insertion of device(15 minutes)
  • Ease of insertion of device measured via VISUAL ANALOGUE SCALE(15 minutes)
  • Airway Sealing Pressure of device measured in mmHg(15 minutes)
  • Complications(2hours)
  • Mean Blood Pressure measured in mmHg(30 minutes)
  • Heart Rate measured in beats per minute(30 minutes)

研究者

发起方
Dr.Mahak Mehta
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr.Mahak Mehta

POST GRADUATE STUDENT

Government Medical College, Haldwani

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