| CTRI Number |
CTRI/2025/01/079725 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| 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
|
Comparison of oropharyngeal leak pressure using i-Gel in blind technique vs video laryngoscope technique in paediatric patients undergoing Laparoscopic surgeries |
|
Scientific Title of Study
|
Comparison of Oropharyngeal Leak Pressure using i-Gel in Blind Technique Versuss Video Laryngoscope in Paediatric Patients undergoing Laparoscopic Surgeries: A Randomised Control 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 |
SRIRAM |
| Designation |
Post graduate Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of Anaesthesia and Critical Care, Armed Forces Medical College, Wanowrie, Pune
Pune MAHARASHTRA 411040 India |
| Phone |
9600245285 |
| Fax |
|
| Email |
ramsri89@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saajan Joshi |
| Designation |
Professor |
| Affiliation |
Army Institute of Cardio thoracic Sciences |
| Address |
Dept of Anaesthesia and Critical Care, Cardiothoracic centre, Wanowrie, Pune. Dept of Anaesthesia and Critical Care, Cardiothoracic centre, Wanowrie, Pune. Pune MAHARASHTRA 411040 India |
| Phone |
9599699348 |
| Fax |
|
| Email |
joe21sf@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
SRIRAM |
| Designation |
Post graduate Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of Anaesthesia and Critical Care, Armed Forces Medical College, Wanowrie, Pune
Pune MAHARASHTRA 411040 India |
| Phone |
9600245285 |
| Fax |
|
| Email |
ramsri89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College, Solapur-Pune Hwy, Wanowrie, Pune, Maharashtra - 411010 |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Armed Forces Medical College, Solapur-Pune Highway, Wanowrie, Pune, Maharashtra - 411040 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sriram S |
Command Hospital - Southern Command, Pune |
OT Complex - Block-5, floor-5, Department of Anaesthesiology Pune MAHARASHTRA |
9600245285
ramsri89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, Armed Forces Medical College |
Approved |
| Institutional Ethical Commitee, Armed Forces Medical College |
Approved |
| Institutional Ethical Commitee, Armed Forces Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Blind insertion of I-Gel |
In the Comparator group i-Gel is placed blindly for ventilation. |
| Intervention |
Video laryngoscope assisted iGel placement |
In the intervention group i-Gel Supraglottic airway is placed using a Video laryngoscope during intubation process for confirmation of position of the i-Gel |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Pediatric patients within a defined age range, typically from 1 year to 10 years old.
2. ASA I and II.
|
|
| ExclusionCriteria |
| Details |
1. Suspected difficult airway.
2. Previous abdominal surgeries.
3. Any comorbidities that would affect time under
anesthesia, intragastric pressure and abdominal
pressure.
4. Weight of less than 5 kg.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare oropharyngeal leak pressure using i-Gel in blind technique vs video laryngoscope assisted placement. |
03 Minutes after i-Gel placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Peak pressure before and
after pneumoperitoneum
2. Number of attempts
3. Insertion time
|
Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
10/02/2025 |
| 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 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
|
1. The second-generation supraglottic airway (SGA) devices have
revolutionized airway management in patients scheduled for surgery under
general anaesthesia (GA). Each device possesses some unique features and has
been used extensively in paediatric patients with varying degrees of success. The blind insertion technique is routinely used
to insert the second generation supraglottic devices. Radiological studies have
shown that incidence of malposition after blind insertion of LMA may range up
to 50-80%. A study in paediatric patients undergoing magnetic resonance imaging
found that radiologically proven malposition of LMA-unique was seen in 42.9% of
children, though the clinical performance of LMA-unique was not hampered.
The advancement in anaesthesia practice is towards performing procedures
under the vision and includes ultrasound assistance for regional blocks,
ultrasound-guided central venous cannulation, fiberoptic/VL guided endotracheal
intubation etc. Anaesthesiologists almost confirm the correct position of the
ETT and corrective measures are immediately taken in the context of misplaced
ETT but often accept sub optimally placed SGAs .
The Difficult Airway Society and the ASA difficult airway guidelines
recommend blind airway management unreliable and Video laryngoscopy (VL) has
become an integral part of airway management. VL offers better glottis
visualization on the screen and enables correct placement of SGA beneath the
glottis, thereby preventing epiglottic down folding or distal cuff displacement
and improving functional or anatomical optimization of SGA .
Oropharyngeal leak pressure (OLP) refers to the airway leak or pressure
airway sealing, and it is the most significant index for evaluating the
security and effectiveness of airway tools . To quantify the effectiveness of
airway sealing and protecting airway in tools, oropharyngeal leak pressure
(OLP) is adopted . Under vision placement of SGA has reported a higher OPLP compared to
blind insertion in adults.
Therefore, we planned a study to compare the video laryngoscope guided i-Gel
insertion with that of the blind insertion technique in paediatric patients
undergoing laparoscopic surgeries with regard to oropharyngeal leak pressure.
We hypothesized that there would be no difference in the oropharyngeal leak
pressure between the video laryngoscope guided and blind insertion technique of
i-Gel in paediatric patients. The primary objective of the study was to compare
the oropharyngeal leak pressure between blind and video laryngoscope guided
insertion. Simultaneously, the insertion characteristics such as the number of
attempts and the time required for successful insertion and the OPLP before and
after pneumoperitoneum were also compared between two insertion techniques of IGEL
in paediatric population. |