| CTRI Number |
CTRI/2024/02/062888 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Observing how videolaryngoscope-guided versus regular blind placement of I-gel supraglottic airway device works in older patients undergoing general anesthesia |
|
Scientific Title of Study
|
A randomised controlled trial comparing the incidence of malposition in videolaryngoscope-guided versus conventional blind insertion of I-gel supraglottic airway in elderly patients under general anaesthesia.
|
| 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 Haritha D |
| Designation |
Academic junior resident |
| Affiliation |
AIIMS patna |
| Address |
Department of Anaesthesiology AIIMS PATNA,phulwari sharif,patna,Bihar
Patna
BIHAR
801507
India |
| Phone |
8012659080 |
| Fax |
|
| Email |
harithaduraisamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kunal singh |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Room no 501, B5A OT complex,IPD building,
Department of Anaesthesiology
AIIMS patna,
Phulwari sharif
Patna
Bihar
Patna
BIHAR
801507
India |
| Phone |
9411514945 |
| Fax |
|
| Email |
drsinghkunal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kunal singh |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Room no 501, B5A OT complex,IPD building,
Department of Anaesthesiology
AIIMS patna,
Phulwari sharif
Patna
Bihar
Patna
BIHAR
801507
India |
| Phone |
9411514945 |
| Fax |
|
| Email |
drsinghkunal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of medical sciences, Patna |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Department of Anaesthesiology, AIIMS Patna |
| 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 Haritha D |
AIIMS Patna |
Department of Anaesthesiology,
AIIMS Patna,
Phulwari sharif ,
Patna,
Bihar
Patna
BIHAR |
8012659080
harithaduraisamy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee AIIMS patna |
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 |
Conventional blind I-gel insertion
(Group B) |
After inducing the patient, airway will be secured using conventional blind insertion of I-gel technique in 3-5 minutes
|
| Intervention |
Video laryngoscopy guided I-gel insertion
(Group A) |
After inducing the patient , airway will be secured using videolaryngoscopy guided I-gel insertion technique in 3-5 minutes |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients planned for elective surgery of duration less than three hours under general anesthesia will be included in the study
ASAPS Grade one two three
BMI less than thirty five |
|
| ExclusionCriteria |
| Details |
High risk of aspiration
Unstable vital signs
Cervical spine problems
BMI more than thirty five
Abnormality of the oral cavity or pharynx High possibility of respiratory complications
Patient refusal for participation in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of malposition of Igel using video laryngoscopy guided versus conventional blind insertion technique
|
2 minutes after induction
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare
-the oropharyngeal leak pressure
-Number of attempts required for the successful placement
-Insertion time
-Postoperative airway morbidity |
From induction to twenty minutes |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "116"
Final Enrollment numbers achieved (India)="116" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/02/2024 |
| Date of Study Completion (India) |
20/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/02/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Due to anatomic and physiological changes associated with aging, geriatric patients are more vulnerable to respiratory and hemodynamic complications during endotracheal intubation and extubation. Supraglottic airway devices (SADs) example I gel minimize airway morbidity while increasing hemodynamic stability in adults.As a person matures, there is an increase in parapharyngeal fat, which increases the risk of airway collapse and apnea.There is increased incidence of malposition of supraglottic device in elderly.There is only limited literature comparing the clinical performance of I gel in geriatric patients.Thus the aim of the study is to compare the incidence of malposition of igel between Videolaryngoscopy guided technique of I-gel insertion and conventional blind insertion technique in elderly undergoing surgical procedures under general anaesthesia |