FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072357 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare between two different types of oral tubes in women posted for laparoscopic surgery 
Scientific Title of Study   Comparative study of the efficacy of Baska mask vs Endotracheal tube in adult women undergoing elective laparoscopic surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Poornima D 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research 
Address  Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  7387893552  
Fax    
Email  poornima.dakshinamurthi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amol Singam 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research 
Address  Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  7387893552  
Fax    
Email  dramol22954@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Poornima D 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research 
Address  Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe


MAHARASHTRA
442001
India 
Phone  7387893552  
Fax    
Email  poornima.dakshinamurthi@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College  
Address  Datta Meghe Institute of Higher Education and Research Sawangi Meghe 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Poornima D   Jawaharlal Nehru Medical College   Department of Anaesthesiology Shalinitai Meghe Superspeciality Hospital AVBRH campus
Wardha
MAHARASHTRA 		 7387893552

poornima.dakshinamurthi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research   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 
Intervention  Baska Mask  1. Appropriate size 2. Frequency: One time 3. Duration: From intubation to extubation (120 minutes) 
Comparator Agent  Endotracheal tube   1. Appropriate size 2. Frequency: One time 3. Duration: From intubation to extubation(120 minutes) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1.Female patients aged between 18-70 years of age.
2.ASA Class I & II patients.
3.All patients willing to give informed consent.
4. Mouth opening more than or equal to 3.
 
 
ExclusionCriteria 
Details  1.ASA Class III and above.
2.Patients’ refusal.
3.Age less than 18 years and more than 70 years.
4.Male gender.
5.Patients having contraindications with laparoscopic surgeries.
6.Patients having allergic reactions to general anaesthetic agents.
7.Mouth opening less than 3 fingers.
8.Intraoperative use of airway devices other than endotracheal tube. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To conclude the effect of Baska mask and endotracheal tube over hemodynamic parameters.   1. Baseline
2. At induction
3. 5 minutes after induction
4. 10 minutes after induction
5. 15 minutes after induction  
 
Secondary Outcome  
Outcome  TimePoints 
To conclude which among the two groups has the minimum airway responses and minimum time of insertion
 		 1. Baseline
2. At induction
3. 5 minutes after induction
4. 10 minutes after induction
5. 15 minutes after induction  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/08/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Abstract:

Background:

The endotracheal tube (ETT) has traditionally been the established method for maintaining airway safety. However, applying excessive pressure with cuffed tubes can lead to decreased blood flow to the airway lining and subsequently result in injury.

The LMA offers numerous advantages when compared to the ETT. These benefits include avoiding direct contact with the tracheal lining, eliminating the need for direct laryngoscopy during insertion, and reducing the occurrence of adverse events such as less frequent coughing, enhanced oxygen saturation during the recovery period, and a lower likelihood of adults experiencing a sore throat.

The Baska mask is a type of supraglottic airway device that incorporates a seamless, non-inflatable flexible cuff designed to imitate an airway. This design serves to reduce the chances of overinflation and lowers the risk of aspiration of gastric contents.

This study aims to compare the efficacy of Baska mask and endotracheal tube in adult women undergoing laparoscopic surgeries.

Aim:

To compare the efficacy of Baska mask and Endotracheal tube in adult women undergoing laparoscopic surgeries

 

Primary objective:

To compare the effect of Baska mask and endotracheal tube over hemodynamic parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure and SPO2.

Secondary objectives:

1.      To compare the airway responses like mean airway pressure and End tidal CO2

2.      To compare the time of insertion

Materials and methods:

A total of 30 female patients with mouth opening more than or equal to 3 fingers and undergoing laparoscpic surgery will be allotted into two groups. The study will be conducted in AVBRH, Sawangi. Group A will be intubated with adequate size endotracheal tube and Group B will receive adequate size Baska mask. Hemodynamic parameters and airway responses will be monitored and the time take and ease of intubation will be compared between both the groups.   
Close