| CTRI Number |
CTRI/2021/11/037886 [Registered on: 10/11/2021] Trial Registered Prospectively |
| Last Modified On: |
28/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound assesment of gastric distension-comparison between baska mask and proseal lma |
|
Scientific Title of Study
|
Comparison of gastric insufflation volume between Baska mask and ProSeal Laryngeal mask airway in patients undergoing elective surgery
A randomized controlled trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
surya |
| Designation |
junior resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
department of anaesthesiology and critical care,old buliding,dhanvanthari nagar,
jipmer,pondicherry,india
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9043122715 |
| Fax |
|
| Email |
surya18moorthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr suman lata |
| Designation |
professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
department of anaesthesiology and critical care,old buliding,dhanvanthari nagar,
jipmer,pondicherry,india
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487315913 |
| Fax |
|
| Email |
sumanlatagupta13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr suman lata |
| Designation |
professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
department of anaesthesiology and critical care,old buliding,dhanvanthari nagar,
jipmer,pondicherry,india
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487315913 |
| Fax |
|
| Email |
sumanlatagupta13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate medical education and research,dhanvantari nagar ,pudhucherry,605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Jawaharlal institute of postgraduate medical education and research,dhanvantari nagar,pudhucherry,605006,india |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| surya |
Jawaharlal institute of postgraduate medical education and research |
department of anaesthesiology and critical care,old buliding,dhanvanthari nagar,
jipmer,pondicherry,india
Pondicherry
PONDICHERRY |
09043122715
surya18moorthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| jipmer institutional ethics commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparsion of gastric insufflation between two groups |
comparison of gastric antral volume in both groups using ultrasound in different time interval. |
| Intervention |
two different types of LMA used for patient undergoing surgery in GA |
two different types of LMA(baska mask and LMA proseal)in order to maintain airway once patient is under anaesthesia and measuring gastic cross sectional area in both groups. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA-classification 1 and 2 patients scheduled up to 4 hours of elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Potentially full stomach patients, requiring RSI
3.Obese patients with BMI > 30 kg/m2
4.Patients with upper gastrointestinal diseases, GERD
5.Upper gastro intestinal surgery
6.Patients with anticipated difficult mask ventilation or intubation
7.Pregnant females
|
|
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Method of Generating Random Sequence
|
Stratified block randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the gastric insufflation volume, assessed by ultrasound guided measurement of change in gastric antral cross-sectional area from baseline between Baska LMA and LMA ProSeal in patients scheduled for elective surgery under general anesthesia. |
gastic insufflation is by ultrasound,intially a baseline data is measured, followed by antral CSA measured from point of LMA insertion upto 5minutes after insertion and also antral CSA measured at the end of surgery |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of oropharyngeal cuff leak pressure with positive pressure ventilation after insertion of Baska mask with that of LMA proseal. |
oropharyngel leak pressure is measured after 5mins of LMA insertion. |
| comparison of time taken to insert both devices. |
time taken to insert LMA from the point of stoping the ventilation to the point of starting the ventilation after lma insertion |
| correlation of gastric insufflation and peak airway pressures |
comparing gastric insufflation and peak airway pressure between two LMA.weather there is increase or not in airways pressure during gastric insufflation |
|
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Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/03/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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)?
Response - NO
|
|
Brief Summary
|
Laryngeal mask airways are the supraglottic airway devices,which are lesser invasive,can be used to give general anaesthesia during surgical procedure.But problem with supraglottic devices risk of aspiration. In this study comparing the gastric insufflation between baska mask and LMA proseal. after randomisation LMA inserted by the trained anaesthetist.Baseline gastric antral volume is measured before inserting the LMA and gastric distension is measured upto 5minutes after insertion obsering frosted glass sign/comet tail artefacts,and gastric antral volume measured at the end of surgery. other parameters which are documented during the study are time taken to insert the LMA indcates which will be easy to insert,oropharyngeal sealing pressure shows maximum pressure that cuff seal can tolerate above that leak will be there, comparison of gastric insufflation and peak airway pressure |