| CTRI Number |
CTRI/2024/07/070156 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of blind fiberoptic intubation with fiberoptic intubation through a device |
|
Scientific Title of Study
|
A prospective randomised controlled study to compare fiberoptic guided intubation characteristics with and without I gel as a conduit in patients undergoing surgery 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 |
Armeen Amir |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8445638814 |
| Fax |
|
| Email |
armeenamir272@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Qazi Ehsan Ali |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417701769 |
| Fax |
|
| Email |
qaziehsanali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Armeen Amir |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital , Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8445638814 |
| Fax |
|
| Email |
armeenamir272@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College and Hospital AMU Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, JNMCH, AMU, Aligarh |
| 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 Armeen Amir |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH |
8445638814
armeenamir272@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 |
(1) ICD-10 Condition: Z419||Encounter for procedure for purposes other than remedying health state, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fiberoptic intubation with I gel |
Patients will be intubated with fiberoptic bronchoscope through I gel undergoing surgery under general anaesthesia. Fiberoptic bronchoscope will be introduced through I gel and then an appropriate sized endotracheal tube will be passed through it. Patients will be observed for any hemodynamic changes before and after intubation. |
| Comparator Agent |
Fiberoptic intubation without I gel |
Patients in this group will be intubated through fiberoptic bronchoscope without using I gel. Any hemodynamic changes will be monitored. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing surgery under general anaesthesia in JN Medical College and Hospital in time period between 2022-2024.
ASA grade 1 and 2
BMI between 18.5-24.5 |
|
| ExclusionCriteria |
| Details |
1.Any oral cavity pathology
2.Mouth opening less than 2.5cm
3.Bleeding disorder
4.Risk of oesophageal reflux
5.Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation time |
Outcome assessed at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare success rate of fiberoptic intubation with & without the aid of device |
Assessed intraoperatively at baseline |
| To grade ease of tracheal intubation |
Assessed during intubation at baseline |
| To compare glottic view using fiberoptic scores |
Assessed intraoperatively at baseline |
| To observe incidence of perioperative complications & postoperative complications |
Assessed intraoperatively & postoperatively in first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
18/07/2024 |
| 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="0"
Months="6"
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
|
Supraglottic airway devices like I gel plays an important role in modern anaesthetic practice. Apart from airway maintenance during selected elective procedures, they may be used in difficult airway management situations. Supraglottic airway devices can allow planned blind or fiberoptic intubation in expected and unexpected difficult laryngoscopes. Among supraglottic airway devices, I gel may become a first option in difficult or failed laryngoscopy as I gel showed best coverage of laryngeal inlet, as well as shortest insertion and intubation time. Therefore, in this study we aim to compare the efficacy of fiberoptic intubation with and without I gel as a conduit in terms of intubation time, number of attempts taken for successful intubation, ease of intubation and trauma during intubation and hemodynamic changes. |