CTRI Number |
CTRI/2017/05/008671 [Registered on: 26/05/2017] Trial Registered Retrospectively |
Last Modified On: |
25/05/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Non-randomized, Multiple Arm Trial |
Public Title of Study
|
comparison of two supraglottic airway devices |
Scientific Title of Study
|
A comparative analysis of the Baska mask vs.I-gel for general anesthesia in surgical patient undergoing laparoscopic cholecystectomy. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Monika Mahajan |
Designation |
Senior Resident |
Affiliation |
Dr. Rajendra Prasad Govt. Medical College, Tanda |
Address |
Department of Anaesthesia
Dr. RPGMC Kangra
Kangra HIMACHAL PRADESH 176001 India |
Phone |
9781484200 |
Fax |
|
Email |
mon.mahajan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Usha Kumari Chaudhary |
Designation |
Assistant Professor |
Affiliation |
Dr. Rajendra Prasad Govt. Medical College, Tanda |
Address |
Deptt of Anaesthesia
Dr. Rajendra Prasad Govt. Medical College
Tanda Kangra HIMACHAL PRADESH 176001 India |
Phone |
9459301813 |
Fax |
|
Email |
chaudhary.ushaarvind@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Usha Kumari Chaudhary |
Designation |
Assistant Professor |
Affiliation |
Dr. Rajendra Prasad Govt. Medical College, Tanda |
Address |
Deptt of Anaesthesia
Dr. Rajendra Prasad Govt. Medical College
Tanda
Kangra HIMACHAL PRADESH 176001 India |
Phone |
9459301813 |
Fax |
|
Email |
chaudhary.ushaarvind@gmail.com |
|
Source of Monetary or Material Support
|
Head of department, department of anaesthesia, department of
health and family welfare Dr. RPGMC, Tanda,Kangra, HP |
|
Primary Sponsor
|
Name |
Dr RPGMCTanda |
Address |
Department of Anaesthesia, Dr. RPGMC Tanda Kangra H.P. |
Type of Sponsor |
Government 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 Monika Mahajan |
Dr. RPGMC,Tanda, Kangra,HP |
Surgey Operation Theatre, Department of Anaesthesia,Dr. RPGMC,Tanda, Kangra,HP
Tanda Kangra HP Kangra HIMACHAL PRADESH |
9781484200
mon.mahajan@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
symptomatic patients of cholecystitis undergoing laparoscopic cholecystectomy, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
comparison of baska mask versus Igel |
comparison of baska mask and Igel for securing airway and the ventilator settings throughout the surgery for a surgery of less than 2 hous duration. |
Intervention |
I GEL vs Baska Mask |
The airway will be secured with with either I gel or Baska mask as device for airway management at the time of induction of anaesthesia |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. American Society of Anesthesiologists physical status score I or II
2. 20 -70 yr old patient of either sex
3. Surgery time of less than 2 hr
4. An elective laparoscopic cholecystectomy
|
|
ExclusionCriteria |
Details |
1. A known or predicted difficult airway
2. A mouth opening of <2.5 cm
3. Increased risk of aspiration of gastric contents
4. Any pathology of neck or upper respiratory tract
5. Obesity (body mass index > 30 Kg/ m2)
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Success and ease of insertion, insertion time and air leak test of baska mask vs Igel |
At the time point of securing airway and for next 5 minutes after securing airway, air leak pressures and leak fraction every 30min.till the end of surgery |
|
Secondary Outcome
|
Outcome |
TimePoints |
Ease of removal and post operative airway morbidity in form of sore throat, dysphonia, dysphagia |
At the time of extubation at end of surgery and at 1 hour and two hours of removal of airway device. |
|
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
|
N/A |
Date of First Enrollment (India)
|
15/05/2017 |
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="5" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Intubation
of trachea using a tracheal tube requires high skill levels, continuous
training and frequent practice1.The laryngeal mask airway(LMA) may
be used to provide a routine airway for use during general anaesthesia or less
frequently as a conduit for tracheal intubation2.In case of
the anticipated and unanticipated difficult airway the supraglottic airway have
a special place in the difficult airway algorithm3. Since the
introduction of the Laryngeal Mask Airway Classic(LMA-C), several other
supraglotticdevices with improved designs have been introduced in order to improve
efficacy and safety.
These
designs offer a cuff that allows a higher seal pressure than the LMA-C and a
drain tube that allows venting of the stomach contents and blind insertion of
standard gastric tubes4. Therefore, these new generation LMAs
provides certain protection against regurgitation and prevent gastric insuffulation
when correctly placed. These devices are a reasonable choice when performing
anesthesia for procedures accompanied by high peak airway pressure, such as
laparoscopic cholecystectomy5.
I-gel is a second generation supraglottic airway, made of a medical grade
thermoplastic elastomer, designed to create a non-inflatable anatomical seal of
the pharyngeal, laryngeal and peri-laryngeal structures.I-gel is easy and reliable to insert and is ideal
for use as a routine airway in anaesthesia as it provides high seal pressures
and reduced trauma. An integrated gastric channel provides an early warning of
regurgitation, facilitates venting of gas from the stomach and allows for the
passing of a suction tube to empty the stomach contents to provide additional
protection against aspiration and has the versatility to be applicable for use
during difficult airway management, as a rescue device and a conduit for intubation
(with fibreoptic guidance).
The Baska mask is a supraglottic airway with high volume suction
clearance. The Baska mask is a new supraglottic airway device, featuring
non-inflatable cuff that may facilitate a better airway seal, seal increases
with IPPV without gastric inflation and novel pharyngeal drainage system that
may reduce the risk of lung aspiration, and integrated bite block.
Till date,
no randomized study has been undertaken to judge its sealing pressure as
compared to i-gel. We hypothesized that with its cuffless membranous bowl; the
baska mask would withstand higher inflation pressures, have a faster placement
time, and have no problem with diffusion of nitrous oxide despite longer
duration of use that would lead to less postoperative laryngopharyngeal
morbidity as compared to i-gel in patients undergoing elective surgical
procedures of 2 hours or less duration.
|