| CTRI Number |
CTRI/2024/04/066325 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of gastric insufflation between Baska mask LMA and Proseal LMA using abdominal ultrasound |
|
Scientific Title of Study
|
Comparison of gastric insufflation between Baska mask LMA and Proseal LMA using abdominal ultrasound- a double blinded randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riyas Mohideen |
| Designation |
junior resident |
| Affiliation |
Sri manakula Vinayagar medical college and hospital |
| Address |
Room no 101
Department : Anaesthesia
Division : speciality OT
Sri manakula vinayagar medical college and hospital Kalitheerthakuppam madagadipet, Pondicherry
India
Pincode -605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
6379976712 |
| Fax |
|
| Email |
ryzmhdn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dilip Chandar |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Room no 101
Department : Anaesthesia
Division : speciality OT
Sri manakula vinayagar medical college and hospital Kalitheerthakuppam madagadipet, Pondicherry
India
Pincode -605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9993031202 |
| Fax |
|
| Email |
dilipchandar2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dilip Chandar |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Room no 101
Department : Anaesthesia
Division : speciality OT
Sri manakula vinayagar medical college and hospital Kalitheerthakuppam madagadipet, Pondicherry
India
Pincode -605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9993031202 |
| Fax |
|
| Email |
dilipchandar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Riyas Mohideen |
| Address |
Sri manakula vinayagar medical college and hospital |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Riyas Mohideen |
Sri Manakula Vinayagar Medical College and Hospital |
Room no 101
Department : Anaesthesia
Division : speciality OT
Sri manakula vinayagar medical college and hospital Kalitheerthakuppam madagadipet, Pondicherry
India
Pincode -605107
Pondicherry
PONDICHERRY |
6379976712
ryzmhdn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
| Patients |
, (1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
baska mask lma |
comparing the gastric insufflation of both BASKA MASK LMA AND PRSEAL LMA
Duration less than 60minutes |
| Comparator Agent |
PROSEAL LMA |
comparing the gastric insufflation of both BASKA MASK LMA AND PRSEAL LMA
Duration less than 60minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
AGE 18 to 60years
ASA physical status 1 and 2
patient undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses and to compare the degree of gastric insufflation by measuring antral cross sectional area and gastric volume |
Assesed immediately after LMA intubation and before extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post perative nausea, vomiting,hoarseness |
1hour |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 1 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
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
|
This is a double blinded randomized controlled study evaluating the gastric isufflation between baska mask and proseal Ima using abdominal ultrasound in early days. SAD is used only for elective procedures. but on the following years it is used in difficult intubation. Proseal LMA is a second generation reusable supraglottic airway device with an airway lumen and a drain tube.The drain tube helps in decompression of stomach and drainage of regurgitant material. BASKA MASK is the latest addition to the supraglottic airway devices,with a cuffless dynamic self inflating membranous bowl and a dual drainage tube system for effective drainage of gastric contents providing option for continuous suctioning of gastric contents. by this study we can compare the gastric insufflation in both Baska Mask LMA and LMA Proseal and to identify which among the two prevent gastric aspiration effectively. |