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CTRI Number  CTRI/2018/12/016712 [Registered on: 18/12/2018] Trial Registered Prospectively
Last Modified On: 21/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   CONFIRMATION OF AIRWAY SECURITY USING ULTRASOUND UNDER ANAESTHESIA 
Scientific Title of Study   CONFIRMATION OF PROSEAL SUPRAGLOTTIC AIRWAY DEVICE PLACEMENT BY LEAK TEST, ULTRASOUND AND FIBEROPTIC BRONCHOSCOPE 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SACHIN E A 
Designation  DNB SR 
Affiliation  MAX SMART SUPER SPECIALTY HOSPITAL  
Address  ROOM NO.1 SECOND FLOOR DEPARTMENT OF ANAESTHESIA MAX SMART SUPER SPECILAITY HOSPITAL, PRESS ENCLAVE ROAD SAKET,NEW DELHI

New Delhi
DELHI
110017
India 
Phone  7042934401  
Fax    
Email  drsachin@live.com  
 
Details of Contact Person
Scientific Query
 
Name  DRARCHANA PURI 
Designation  SENIOR CONSULTANT 
Affiliation  MAX SMART SUPER SPECIALTY HOSPITAL  
Address  ROOM NO.1 SECOND FLOOR DEPARTMENT OF ANAESTHESIA MAX SMART SUPER SPECILAITY HOSPITAL PRESS ENCLAVE ROAD SAKET NEW DELHI

New Delhi
DELHI
110017
India 
Phone  98130085923  
Fax    
Email  DR.ARCHANA.PURI@GMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  SACHIN E A 
Designation  DNB SR 
Affiliation  MAX SMART SUPER SPECIALTY HOSPITAL  
Address  ROOM NO.1 SECOND FLOOR DEPARTMENT OF ANAESTHESIA MAX SMART SUPER SPECILAITY HOSPITAL, PRESS ENCLAVE ROAD SAKET,NEW DELHI

New Delhi
DELHI
110017
India 
Phone  7042934401  
Fax    
Email  drsachin@live.com  
 
Source of Monetary or Material Support  
MAX SMART SUPER SPECIALTY HOSPITAL, SAKET,NEW DELHI 
 
Primary Sponsor  
Name  MAX SMART SUPER SPECIALITY HOSPITAL 
Address  PRESS ENCLAVE ROAD SAKET NEW DELHI 110017 
Type of Sponsor  Private hospital/clinic 
 
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 
DR MUKUL KAPOOR  MAX SMART SUPER SPECIALITY HOSPITAL  OPERATION THEATRE, FIRST FLOOR,MAX SMART SUPER SPECIALITY HOSPITAL SAKET PRESS ENCLAVE ROAD NEW DELHI 110017
New Delhi
DELHI 
997188873

MUKUL.KAPOOR@MAXHEALTHCARE.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.asa 1-3
2.patients requiring general anesthesia with proseal laryngeal mask airway 
 
ExclusionCriteria 
Details  1. Patients with anticipated difficult airway

2. Pulmonary disease

3. ASA 4 and ASA 5

4. Hypersensitivity to one or more medications

5. Previous thoracic surgeries

6. Pregnancy

7. BMI > 30

8. Patients at risk of gastric aspiration 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To determine whether ultrasound examination of SAD placement is comparable with conventional leakage test to determine need of reinsertion of Proseal SAD.
2.comparison of fiberoptic and ultrasound methods for confirmation of proseal SAD placement 
ONLY ONE TIME POINT AFTER INDUCTION OF ANAESTHESIA  
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparing the time duration required by each method to confirm Proseal SAD placement  time required for leak test,ultrasound and fiberoptic examination will be noted 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/12/2018 
Date of Study Completion (India) 22/04/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

All patients will undergo a complete pre-anesthetic evaluation and NPO for 6 hours. All patients will be administered general anesthesia for the procedure. A standardized protocol for induction and maintenance of anesthesia will be follow which would comprise of intravenous fentanyl (1-2mcg/kg) followed by propofol (1.5-2mg/kg) for induction. Airway will be secured by an appropriate size Proseal SAD following administration of a non-depolarizing muscle relaxant. Size 3 Proseal will be use for patients weighing 30-50 Kg, size 4 for patients weighing 40-70 Kgs and size 5 for patients weighing 70-100 Kg.

Anesthesia will be maintained with desflurane in oxygen and nitrous oxide titrated to maintain FiO2 of 0.5 at all times.A non-depolarizing muscle relaxant will be administered for maintenance of neuromuscular blockade. Standard volume control ventilation settings will be used in both groups with tidal volume of 8ml/kg, to maintain minute ventilation of 100ml/kg and end-tidal carbon dioxide (EtCO2) between 30-40 mm Hg. Leak pressure test will be conducted in all cases receiving Proseal SAD and the leak pressure shall be recorded.

Airway leak pressure is defined as “the airway pressure (PL) at which the leak was heard with fresh gas flow (FGF) at 3 L/min and adjustable pressure limiting (APL) valve closed gradually up to 40 cm H2O”. After the leak test, ultrasound examination on front of neck will be done in three planes and scoring done using the Ultrasound score system as below:

Plane             Ultrasound examination                                                                                       Comments

THT             2 cuff shadows                                                                                                      symmetrical/asymmetrical

TLS             Edge of the cuff tip and the shape of the cuff                                                       distorted and irregular/ smooth and regular

PPL             visualize the cuff tip and esophagus in the same plane by adjusting transducer   Possible/ impossible

THT = transverse plane between hyoid bone and thyroid bone;

TLS =transverse plane of lateral suprasternal notch;

PPL = parasagittal plane of pharynx and larynx.

Fiberoptic examination will be done through Proseal SAD to confirm the position of SAD. The fiberoptic endoscope will be typically positioned just proximal to the end of the ventilator conduit, and then an attempt will be made to advance it under the epiglottis to see the vocal cords. Optimal placement is when the tip of the Proseal lying behind the arytenoids with a visible epiglottis, with no folding or intrusion into the airway, and with the vocal cords visible when the fiberscope advanced under the epiglottis.All other situations will be considered suboptimal placement. Fiberoptic examination will be done in only those cases where leak test is positive.

At the end of the procedure, neuromuscular blockade will be reversed and post extubation patient will be shifted to PACU for observation. 

 
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