FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/04/042302 [Registered on: 29/04/2022] Trial Registered Prospectively
Last Modified On: 03/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To evaluate if LMA Gastro can be used as a safe alternative to endotracheal tube in General Anesthesia for successfully completing Endoscopic procedures.  
Scientific Title of Study   Efficacy of the new LMA Gastro Airway as an Airway device in patients undergoing Endoscopic procedures under General Anaesthesia: a single centre observational study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rashmi Babykutty 
Designation  Post Graduate resident 
Affiliation  Christian Medical College, Vellore 
Address  Department of Anesthesia Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  07837649718  
Fax    
Email  rashmibabykutty11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rashmi Babykutty 
Designation  Post Graduate resident 
Affiliation  Christian Medical College, Vellore 
Address  Department of Anesthesia Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  07837649718  
Fax    
Email  rashmibabykutty11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rashmi Babykutty 
Designation  Post Graduate resident 
Affiliation  Christian Medical College, Vellore 
Address  Department of Anesthesia Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  07837649718  
Fax    
Email  rashmibabykutty11@gmail.com  
 
Source of Monetary or Material Support  
CHRISTIAN MEDICAL COLLEGE, VELLORE  
 
Primary Sponsor  
Name  CHRISTIAN MEDICAL COLLEGE VELLORE  
Address  CHRISTIAN MEDICAL COLLEGE, VELLORE TAMIL NADU632004 
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 
DrRaj Sahajanandan   CHRISTIAN MEDICAL COLLEGE VELLORE   Gastroscopy and ERCP Suite,CHRISTIAN MEDICAL COLLEGE VELLORE TAMIL NADU
Vellore
TAMIL NADU 
8489622336

rajsahajanandan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD CMC VELLORE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil Intervention  Nil Intervention 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All American Society of Anesthesiologists (ASA) 1and 2 patients who will require Upper GI Endoscopic procedure under General Anesthesia and have consented to participate in the study.  
 
ExclusionCriteria 
Details  1. Patients who refuse to consent
2. ASA 3 and above
3. Anticipated difficult airway
4. High risk of aspiration
5. Cardiac diseases
6. Airway anomalies
7. Emergency endoscopic procedures  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is to look at the percentage of Successful placement of LMA Gastro, which is defined as, Tidal volumes more than or equal to 4ml per kg, No peak pressures more than 30 cm of H2O and a good EtCo2 waveform in the range of 28 to 30  Intraoperative period ,approximately 30mins to 1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of hemodynamic Instability   Intraoperative period, approximately 30mins to 1 hour 
Incidence of airway compromise   Intraoperative period, approximately 30mins to 1 hour 
Incidence of laryngospasm   Intraoperative period, approximately 30mins to 1 hour 
Incidence of post procedural Sore throat   30mins after completion of procedure  
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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)   30/04/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The Laryngeal mask airway, a supraglottic airway device, over the years has gained popularity in various settings like, management of difficult airway, cardiopulmonary resuscitation and non operating room anesthesia. With the advancement of interventional endoscopic procedures, the gastroenterology suite is a growing area for non operating room anesthesia as the practice is inclining more towards deep sedation / general anesthesia rather than conscious sedation. Though general anesthesia is the choice in practice, the need for a safer, fast and gentle airway device is necessary.

LMA Gastro is a new 2nd generation supraglottic airway device which is specially designed for Upper Gastrointestinal endoscopy. It comes with dedicated channel for insertion of endoscope with an internal diameter of 14mm and a separate channel for ventilation parallel to it. The endoscopy port ends at the distal tip of the cuff in such a way that it aligns itself to the upper esophageal opening. It also comes with an integrated cuff pressure indicator to monitor the cuff pressure and an adjustable holder with strap to prevent any displacement or dislodgement of the tube. The advantage of LMA Gastro over other SAD is that it facilitates esophageal intubation without compromising the airway and positive pressure ventilation.  

All ASA1 and ASA2 patients who are posted for elective gastroscopic procedures requiring General anesthesia, after taking an informed consent, will be included in this study. Patient refusal, patients with ASA>= 3, with anticipated difficult airway, high risk of aspiration( morbid obesity BMI > 40), GERD , Cardiac diseases, Airway anomalies, Emergency Gastroscopic  procedures will be excluded from the study.  All the patients will be recruited by the primary investigator and advised fasting for solids from 12 midnight and clear fluids from 5am. After securing a good intravenous (IV) access and connecting all ASA standard monitors, the patient will be sedated with IV Propofol, following which LMA Gastro will be introduced. 

The criteria for successful placement of LMA Gastro are:

i)Tidal volumes >/= 4ml/kg

ii) No peak pressure elevation >30 cm H2o 

iii)Good EtCo2 waveform in the range of 28-30

iv)Not >/= 3 attempts and bilaterally equal chest rise.

Other parameters such as the hemodynamics, saturation, the time taken to wake up the patient and shift to recovery and any occurrence of laryngospasm, airway obstruction or requirement of  airway manipulations after removal of LMA Gastro will be monitored during the procedure. In Recovery/Post Anesthesia Care Unit (PACU) patient will be evaluated for any hoarseness in voice or sore throat. The incidence of these parameters will be analyzed and thereby the efficacy of LMA Gastro for Gastroscopic procedures will be evaluated.

 
Close