| CTRI Number |
CTRI/2023/08/056721 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
19/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Orophayrngeal seal pressure and peak airway pressure between Baska mask and I gel in patients undergoing laparoscopic surgeries. |
|
Scientific Title of Study
|
Orophayrngeal seal pressure and peak airway pressure between Baska mask and I gel in patients undergoing laparoscopic surgeries: A 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 |
Dr Shalini |
| Designation |
PG Student |
| Affiliation |
Maharaja Agrasen Medical College, Agroha, Hisar |
| Address |
Department of Anesthesiology and critical care, Agroha, Hisar
Hisar
HARYANA
125047
India |
| Phone |
7982145046 |
| Fax |
|
| Email |
shalini.verma1295@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetika Duggal |
| Designation |
Professor and HOD |
| Affiliation |
Maharaja Agrasen Medical College, Agroha, Hisar |
| Address |
Department of Anesthesiology and critical care , Agroha, Hisar
Hisar
HARYANA
125047
India |
| Phone |
8930200806 |
| Fax |
|
| Email |
drgeetikaduggal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini |
| Designation |
PG Student |
| Affiliation |
Maharaja Agrasen Medical College, Agroha, Hisar |
| Address |
Department of Anesthesiology and critical care , Agroha, Hisar
Hisar
HARYANA
125047
India |
| Phone |
7982145046 |
| Fax |
|
| Email |
shalini.verma1295@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaja Agrasen Medical College, Agroha, Hisar |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology and critical care |
| Address |
Maharaja Agrasen Medical College, Argoha,Hisar |
| 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 Shalini |
Maharaja Agrasen Medical College, Argoha, Hisar |
Department of Anesthesiology and critical care, OT complex
Hisar
HARYANA |
7982145046
shalini.verma1295@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Committee for human research mamc agroha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baska Mask |
The entire body of the mask will be lubricated with water
based lignocaine gel. After opening the mouth, the proximal , firmer part of baska mask will
be compressed between thumb and two fingers. It will be pushed past the front teeth towards
hard palate, avoiding the tongue.. If necessary, when the mask is fully inserted within the mouth, the tab , is used to help negotiate the palato- pharyngeal curve.
Oropharyngeal seal pressure will be measured just after insertion, 1 min after induction (T1),
5 min before pneumoperitonium (T2), 5 min after pneumoperitonium (T3), 5 min before
deflation of pneumoperitonium (T4), and 5 min after deflation of pneumoperitonium (T5).
Peak airway pressure will be measured at 1 min after induction (T1), 5 min before
pneumoperitonium (T2), 5 min after pneumoperitonium (T3), 5 min before deflation of
pneumoperitonium (T4), and 5 min after deflation of pneumoperitonium (T5) . |
| Comparator Agent |
I gel |
I-gel will be grasped firmly along integral bite block. The leading soft tip will be inserted into patient’s mouth directed towards hard palate and then will be glided
downwards and backwards along hard palate with continuous but gentle push until a definitive resistance will be felt and incisors will rest on the integral bite-block.
Oropharyngeal seal pressure will be measured just after insertion, 1 min after induction (T1),
5 min before pneumoperitonium (T2), 5 min after pneumoperitonium (T3), 5 min before
deflation of pneumoperitonium (T4), and 5 min after deflation of pneumoperitonium (T5).
Peak airway pressure will be measured at 1 min after induction (T1), 5 min before
pneumoperitonium (T2), 5 min after pneumoperitonium (T3), 5 min before deflation of
pneumoperitonium (T4), and 5 min after deflation of pneumoperitonium (T5) . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
80 patients of either sex, aged 18–60 years, belonging to American Society of Anaesthesiologists (ASA) physical status class I and II presenting for laparoscopic surgery
under general anaesthesia will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patient refusal to consent
Obesity (body mass index ≥30 kg/m2)
Pregnancy
Known or predicted difficult airway (Mallampati grade 3/4, mouth opening < 3 cm,
thyromental distance < 6cm , positive upper lip bite test)
Reduced lung compliance
High risk for pulmonary aspiration (non fasted, gastroesophageal reflux disease)
Patients with known cardiorespiratory illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine oropharyngeal Seal Pressure in baska mask & I-gel after creating
pneumoperitoneum in patients undergoing laparoscopic surgeries.
2.To determine peak airway pressure in baska mask & I-gel after creating
pneumoperitoneum in patients undergoing laparoscopic surgeries. |
Measured at 1 min after induction, at 5 mins before and after creating pneumoperitoneum, and at 5 mins before and after deflation of pneumoperitoneum. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine ease of insertion & time of insertion in baska mask and I gel. |
It is taken as the time from picking up the device till
appearance of a capnograph waveform. The insertion time is the sum of all the attempts taken.It will be noted using a stopwatch by an independent assessor. |
|
|
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)
|
01/09/2023 |
| 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="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
|
Airway management is considered as an integral part of general anesthesia. Endotracheal
intubation has been considered as a conventional gold standard method for securing the airway
during GA.1 In the last few years , many supraglottic airway devices (SADs) have been
introduced in clinical practice. Supraglottic airway devices has changed the scenario from
’unable to intubate and ventilate’ to ’unable to intubate but able to ventilate’.1 These devices has
much importance for patients with difficult tracheal intubation or where intubation is
impossible. 1 Oropharygeal seal pressure and peak airway pressure is an important parameter
for safe use during laparoscopic surgeries.
In this study, we evaluated the performance of the baska mask , a new extraglottic airway
device (EAD) for use in anesthesia in adult patients undergoing a variety of surgical
interventions. The purpose of this study is to compare the oropharyngeal seal pressure and peak airway
pressure between baska mask and I gel after creating pneumoperitoneum in laparoscopic
surgeries. |