| CTRI Number |
CTRI/2024/10/074678 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of supraglottic airway devices in laparoscopic cholecystectomy patients |
|
Scientific Title of Study
|
Comparision of efficacy of Air Q laryngeal mask airway and Baska mask in patients undergoing laparoscopic cholecystectomy: A prospective randomized clinical study |
| 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 Arvind Khare |
| Designation |
Senior Professor |
| Affiliation |
Jawahar lal Nehru medical college , Ajmer , Rajasthan |
| Address |
Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan
Ajmer RAJASTHAN 305001 India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arvind Khare |
| Designation |
Senior Professor |
| Affiliation |
Jawahar lal Nehru medical college , Ajmer , Rajasthan |
| Address |
Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan
Ajmer RAJASTHAN 305001 India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arvind Khare |
| Designation |
Senior Professor |
| Affiliation |
Jawahar lal Nehru medical college , Ajmer , Rajasthan |
| Address |
Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan
Ajmer RAJASTHAN 305001 India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, new OT, 1st floor, JLN hospital, Kalabagh, Ajmer, Rajasthan 305001 |
|
|
Primary Sponsor
|
| Name |
JLN medical college |
| Address |
New OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan 305001 |
| 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 Rajeev Jain |
JLN medical college and hospital |
Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan 305001 Ajmer RAJASTHAN |
9680110086
drrajeevjain8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethecal committee Jawarlal Nehru medical college, Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Air Q LMA |
The air-Q
®
Intubating Laryngeal Airway (air-Q; Mercury Medical, Clearwater,
FL, USA) is a new supraglottic airway device (SAD) intended for use as a primary
airway as well as an aid for tracheal intubation in situations of anticipated or
unanticipated difficult airways. Its design includes a large airway tube inner
diameter (ID), a short airway tube length and a tethered, removable standard 15-
mm circuit adapter. These features enable direct insertion of larger tracheal tubes
(up to 7.5 and 8.5 mm IDs for air-Q sizes 3.5 and 4.5, respectively) through the
7
airway tube and reduce the tracheal tube length requirements imposed by some
SADs to ensure tracheal tube cuff placement below the level of the vocal cords.[ |
| Comparator Agent |
Baska mask |
Baska Mask which incorporates the features of 2nd generation LMA with additional
feature that provide a higher seal pressure than other LMAs as during intermittent
positive pressure ventilation (IPPV) the seal apposes to the glottis incrementally to
augment seal pressure with increasing airway pressure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60years. ASA grade I & II. BMI less then 30. Under going laparoscopic cholecystectomy under general anaesthesia. Surgery lasting up to 90 minutes. |
|
| ExclusionCriteria |
| Details |
ASA grade III and above. Known difficult airway (with recent history upper respiratory tract infection, any obvious scar or mass or ulcer in neck, cleft lip/palate, adenotonsilar hypertrophy or lingual tonsils , obese syndromic, microganthia, congenital malformations involving respiratory tract, cervical spine disorder). Mouth opening less then 2.5 cm . With increase risk of aspiration of gastric contents (NBM status unknown, non fasted, gastrointestinal stricter or stenosis ). Obesity BMI more then 30kg per meter square. Negative patient consent. Pregnant patient |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal leak pressure of air Q LMA and Baska mask |
Grading point system |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Number of attempts for successful insertion of Air Q LMA and Buska mask
2 Time taken for successful insertion of the devices
3 Ease of successful insertion of orogastric tube through the drain tube of both the devices
4 Flexible fiberoptic visualization of glottic through the airway tube of both the devices
5 Hemodynamic variables heart rate, systolic BP, diastolic BP, mean arterial pressure
6 Peak airway pressure pre and post pneumoperitonium following insetion of both the devices.
7 Incidence of postoperative adverse events between Air Q LMA and Baska mask like-
Blood staining on device
Sore throat
Hoarseness of voice
Aspiration
Regurgitation |
Subjective scale and grading point system |
|
|
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)
|
12/10/2024 |
| 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 Applicable |
| 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
|
Study title- Comparison of Efficacy of Air Q Laryngeal Mask Airway And Baska Mask In Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Study. The study will be conducted in the Department of Anaesthesiology at JLN Medical college and Associated Group of Hospitals, Ajmer. It is a hospital based Prospective, Randomized, Double Blind, interventional study. To our knowledge, none of the study has compared the AIR Q laryngeal mask airway & BASKA Mask till now so we. So, we decided to compare the safety and efficacy of AIR Q laryngeal mask airway & BASKA Mask used in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. Our primary objective will be to compare the Oropharyngeal leak pressure of both devices and secondary objective will be to compare number of attempts and time for successful insertion, ease of orogastric tube (OGT) insertion, fibre optic visualization of glottis, haemodynamic, peak airway pressure before and after pneumoperitoneum and complications at emergence and postoperatively. A sample size of z=80 patients (n=40 in each group) will be estimated based on the previous studies. This calculation will be deduced with an alpha error of 0.05 ,beta error of 0.20 and power of 80% . The randomization will be done by opaque sealed envelope technique. After obtaining the approval by ethical committee of the hospital and consent for general anaesthesia will be taken from the patient Patients will be divided into two groups {Group A and Group B} Preanesthetic evaluation will be done on previous day of surgery. Nil per oral status of at least 8 hours will be maintained. Premedication with tab Alprazolam 0.25 mg will be given on previous night. The frequency distribution of categorical data will be expressed as frequency count and proportions. Continuous data will be expressed as mean +S.D. The significance of the difference in proportion of cases will be inferred by chi square test or fishers exact test as appropriate. Significant differences in the distribution of continuous data will be explored using a student’s t test. 95% confidence interval around the point estimate will be reported. A ’P’ value <0.05 will be considered significant. Categorically, the data analysis will be performed using comprehensive statistical software platform SPSS 28.9 Windows including power meta- analysis for functional data analogue. Other descriptive and inferential statistics may be used as per data collected |