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CTRI Number  CTRI/2020/10/028336 [Registered on: 12/10/2020] Trial Registered Prospectively
Last Modified On: 09/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Study to find which airway can be placed easily in patients under anaesthesia.  
Scientific Title of Study   A Randomised Control Trial to compare the ease of insertion of Ambu Auragain Laryngeal Mask Airway and LMA Protector in Anaesthetised adults.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhinaya Murugappan  
Designation  Post Graduate 
Affiliation  Srm Medical College Hospital and Research Centre 
Address  Room no.101,Department of Anaesthesiology Srm Medical College Hospital, Potheri, Kattankulathur,603203, Kancheepuram, TAMIL NADU, India.

Kancheepuram
TAMIL NADU
603203
India 
Phone  7299073639   
Fax    
Email  abhinaya1306@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  CR Saravanan 
Designation  Associate Proffessor  
Affiliation  Srm Medical College Hospital and Research Centre 
Address  Room no 201,Department of Anaesthesiology Srm Medical College Hospital, Potheri, Kattankulathur,603203, Kancheepuram, TAMIL NADU, India.

Kancheepuram
TAMIL NADU
603203
India 
Phone  9884001153  
Fax    
Email  drcrsaravanan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  CR Saravanan 
Designation  Associate Proffessor  
Affiliation  Srm Medical College Hospital and Research Centre 
Address  Room no 201,Department of Anaesthesiology Srm Medical College Hospital, Potheri, Kattankulathur,603203, Kancheepuram, TAMIL NADU, India.

Kancheepuram
TAMIL NADU
603203
India 
Phone  9884001153  
Fax    
Email  drcrsaravanan@gmail.com  
 
Source of Monetary or Material Support  
SRM Institute of Science and Technology, Srm nagar, Potheri, kancheepuram District, Tamilnadu - 603203. 
 
Primary Sponsor  
Name  SRM medical College Hospital  
Address  Room no 1, B Block, Department of Anaesthesiology Potheri Kattankulathur 603203 Kancheepuram TAMIL NADU  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Abhinaya Murugappan  SRM Medical College Hospital and Research Centre   Room no 101, B block,Department of Anaesthesiology Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU 
7299073639

abhinaya1306@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AMBU Auragain  To find the ease of insertion of AMBU Auragain in anaesthestised adults 
Intervention  LMA Protector  To find the ease of insertion of LMA Protector in anaesthestised adults 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA grade I-II
2. Surgeries requiring general anaesthesia
with duration less than 1 hour .
3. BMI <30
4. MPC I to III
5. Upper lip bite test possible
6. Inter incisor distance > 2.5 cm
7. Thyromental distance > 6cm
8. Full range of neck movement
 
 
ExclusionCriteria 
Details  1 Surgeries requiring prone or lateral
position.
2 High risk of regurgitation (non
fasted,morbid obesity, pregnancy, GERD)
3 Preoperative sore throat or any respiratory
tract infection
4 Airway pathology, facial abnormalities
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the ease of insertion including the insertion time and number of attmepts.

 
from the start of insertion to appearance of square wave in capnography

 
 
Secondary Outcome  
Outcome  TimePoints 
Oropharyngeal Leak pressure (OLP)  From securing LMA till fall in peak pressure 
Fibreoptic assessment of larynx  grading 
Success of gastric tube insertion  easy/difficult/impossible 
Postoperative complications   till 45mins after the removal of supraglottic airway device 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/10/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

·         After obtaining institutional ethical committee approval, 66 patients between 18 to 60 years of age, posted for surgeries under general anaesthesia, will be recruited.

·         Informed consent, written in their own language will be obtained from all the patients.

·         Patients will be allocated to two groups (AMBU Auragain-AA group /LMA Protector- LP group) by computer generated random assignment prior to the start of the study. Patients  will be unaware of the group allocation.

·         After ensuring that patients are adequately fasted they will be premedicated with injection midazolam 0.03mg/kg IV and patients will be preloaded with 5 mL/kg of Ringer lactate solution through 18 gauge intravenous (IV) cannula half an hour prior to the procedure.

·         Monitors such as electrocardiography, pulse oximetry (SpO2) and non invasive blood pressure (NIBP) will be connected to the patient, baseline values will be documented and intraop hemodynamics will be monitored every 10 minutes.

·         Induction of anaesthesia will be done with fentanyl 2 μg/kg i.v. and propofol 2–2.5 mg/kg i.v. and maintenance with 50% oxygen and 50% air with 1 minimum alveolar concentration of sevoflurane. Patients then will be ventilated with a face mask till adequate jaw relaxation was achieved.

·         Before inserting the device, the cuff will be inflated with maximum permissible air (as per manufacturer’s recommendation), and the cuff pressure (ex vivo) was measured with a cuff pressure monitor.

·         Appropriate sized SGAs will be fully deflated and lubricated with a water-soluble gel. After the adequate depth of anaesthesia and once the muscle relaxation is achieved the patient’s head will be placed in a “sniffing” position (neck flexion and head extension) and lma will be inserted.

·         After insertion, the device will be inflated with the maximum permissible volume of air, and the air entry will be checked on both sides of the chest. The in vivo cuff pressure will be measured.

·         The pharyngeal mucosal pressure will be calculated as: P= Pin vivo �’ Pex vivo.

·         We will record the number of insertion attempts and the time needed for SGA placement, (measured from when the SGA will be picked up until the connection to the breathing circuit and the appearance of 1st square waveform in capnograph).

·         The the ease of insertion will be graded as

        1 - easy

        2 - satisfactory

        3 - difficult (when deep rotation and jaw thrust or a second attempt is used for proper                    device insertion).

·          An effective airway will be judged by an absence of audible leak , normal thoracoabdominal movement and square wave capnograph trace. If there is a leak, the SGA will be repositioned. If leak persists after a total of three attempts, the patient will be intubated with an endotracheal cuffed tube and will be recorded as failed insertions.

·         The anatomical alignment of the device to the larynx will be viewed through FOB just above the ventilating orifice. A grading scale will be used to assess the grade of view as follows:

•      4= only vocal cords seen;

•      3 = vocal cords plus posterior epiglottis seen;

•      2 = vocal cords plus anterior epiglottis seen;

•      1 = vocal cords not seen, but function adequate;

•      0 = failure to function where vocal cords not seen fibre-optically.

·         Before commencement of the surgery, the cuff will be inflated with a manometer and cuff pressure was set to 60 cm of H2O. OLP will be measured by closing the expiratory valve of the breathing circuit and delivering a gas flow of 3 L/min until the seal pressure.

·          A lubricated 16 Fr gastric tube will be introduced via the drain tube of both the devices to aspirate gastric contents. Ease of insertion of gastric tube through the gastric channel will be noted on a 3-point scale of 1–3 (1 = passed easily, 2 = passed with difficulty, 3 = impossible to pass).

·         Once the surgery is completed, awake extubation will be done.

·         Post procedure for 45 minutes patients hemodynamics will be monitored and they will also be monitored for complications like mucosal injury, persistent cough, laryngospasm, dysphonia, sore throat.

 
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