| CTRI Number |
CTRI/2022/10/046196 [Registered on: 06/10/2022] Trial Registered Prospectively |
| Last Modified On: |
22/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of two airways(LMA) in patients undergoing appendicectomy(surgery to remove the appendix when it is infected) under general anaesthesia |
|
Scientific Title of Study
|
Comparative evaluation of Blockbuster laryngeal mask airway and Proseal laryngeal mask airway in patients undergoing laparoscopic appendicectomy under general anaesthesia:A non inferiority randomised 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 |
Dr Anilkumar Ganeshnavar |
| Designation |
Professor |
| Affiliation |
SN Medical College and HSK Hospital ,Navanagar,Bagalkot |
| Address |
Department of Anaesthesia,
S.Nijalingappa Medical College and HSK Hospital,
Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
9964526598 |
| Fax |
|
| Email |
anilganesh22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anilkumar Ganeshnavar |
| Designation |
Professor |
| Affiliation |
SN Medical College and HSK Hospital,Navanagar,Bagalkot |
| Address |
Department of Anaesthesia,
S. Nijalingappa medical College and HSK Hospital,
Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
9964526598 |
| Fax |
|
| Email |
anilganesh22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinduja B Nair |
| Designation |
PG in Anaesthesia |
| Affiliation |
SN Medical College and HSK Hospital,Navanagar,Bagalkot |
| Address |
Department of Anaesthesia,
S.Nijalingappa Medical College and HSK Hospital,
Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
9482562817 |
| Fax |
|
| Email |
vindujabnair@gmail.com |
|
|
Source of Monetary or Material Support
|
| S Nijalingappa Medical College and HSK Hospital |
|
|
Primary Sponsor
|
| Name |
S Nijalingappa Medical College and HSK Hospital |
| Address |
1st floor Major OT complex,S Nijalingappa Medical College and HSK Hospital,Bagalkot |
| Type of Sponsor |
Private medical college |
|
|
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 Anilkumar Ganeshnavar |
1st floor,major OT Complex |
S.Nijalingappa Medical College and HSK Hospital
Bagalkot
KARNATAKA |
9964526598
anilganesh22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC-INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K37||Unspecified appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blockbuster laryngeal mask airway |
Maintenance of airway using Blockbuster laryngeal mask airway approximately 1 hour depending on duration of surgery. |
| Comparator Agent |
Proseal laryngeal mask airway |
Maintanance of airway using Proseal laryngeal mask airway compared to Blockbuster laryngeal mask airway approximately for 1 hour depending on duration of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA physical status I-III
2.Airway assessment by Malampatti grade I-III
3.Patients undergoing elective laparoscopic appendicectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Patient refusal to give consent
2.Anticipated difficult airway(mouth opening<2cm)
3.Upper respiratory tract infection
4.BMI ≥35kg/m²
5.History of radiotherapy of neck
6.Pregnancy
7.Oropharyngeal pathology
8.Previous airway surgeries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare oropharyngeal leak pressure of Blockbuster laryngeal mask airway and Proseal laryngeal mask airway in patients undergoing laparoscopic appendicectomy under general anaesthesia |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare both the devices for ease of insertion, time of insertion,number of insertion attempts, ease of orogastric tube placement, fibreoptic visualisation of glottis and perioperative pharyngolaryngeal complications if any |
2 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2 |
|
Date of First Enrollment (India)
|
13/10/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 development
of supraglottic airway devices has revolutionized airway management during
general anaesthesia. They
provide niche between facemask and tracheal tube. It
provides less traumatic and less invasive means of securing airway in surgical patients. High SAD (supraglottic airway device)
oropharyngeal leakage pressure is required for airway protection during
laparoscopic surgery, on obese patients and in patients with restrictive lung
disease. If airway sealing is inadequate, the
use of SADs is a potential risk, such as cause gastric insufflations, exposing
the patient to the risk of pulmonary aspiration of gastric content. In this study we will be comparing the
oropharyngeal leak pressure of two second generation laryngeal mask airways, Blockbuster
LMA(laryngeal mask airway) and Proseal LMA in
patients undergoing laparoscopic appendicectomy
under general anaesthesia. A total of 80 patients
of American society of Anaesthesiologists(ASA)
physical status I-III of age group 18-60years will be randomly allocated into 2 groups ( group A
Blockbuster LMA and group B Proseal LMA) of 40 each.
Oropharyngeal leak pressure (OLP),ease of insertion, insertion attempts
,insertion time, ease of orogastric tube
(OGT) insertion ,fibreoptic
visualization of glottis and complications will be assessed.
|