| CTRI Number |
CTRI/2023/10/059006 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
a comparison of success rate of blind endotracheal intubation through i-gel and ambu auragain in adult. |
|
Scientific Title of Study
|
comparison of i-gelTM and ambu AuraGain as a conduit for blind endotracheal intubation in adult patients in elective surgeries. |
| 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 rajat sisodia |
| Designation |
pg student |
| Affiliation |
MAHARAJA AGRASEN NMEDICAL COLLEGE, AGROHA. |
| Address |
Department of anesthesia,
MAaharaja Agrasen Medical College AGROHA Hisar.
Hisar
HARYANA
125047
India |
| Phone |
7404884337 |
| Fax |
|
| Email |
rajatsisodia94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sheetal |
| Designation |
Proffessor |
| Affiliation |
MAHARAJA AGRASEN NMEDICAL COLLEGE, AGROHA. |
| Address |
Department of anesthesia,MAHARAJA AGRASEN MEDICAL COLLEGE, Agroha, Hisar
Hisar
HARYANA
125047
India |
| Phone |
9812426301 |
| Fax |
|
| Email |
Sheetalbhatia1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr rajat sisodia |
| Designation |
pg student |
| Affiliation |
MAHARAJA AGRASEN NMEDICAL COLLEGE, AGROHA. |
| Address |
department of anesthesia, MAHARAJA AGRASEN MEDICAL COLLEGE, AGROHA.
Hisar
HARYANA
125047
India |
| Phone |
7404884337 |
| Fax |
|
| Email |
rajatsisodia94@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of anesthesia, maharaja agrasen medical college, agroha. |
|
|
Primary Sponsor
|
| Name |
maharaja agrasen medical college |
| Address |
department of anesthesia, maharaja agrasen medical college agroha, 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 RAJAT SISODIA |
maharaja agrasen medical college |
department of anesthesia, ot complex, MAHARAJA AGRASEN MEDICALCOLLEGE, AGROHA, hisar.
Hisar
HARYANA |
7404884337
rajatsisodia94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T758||Other specified effects of external causes, (2) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AMBU AURAGAIN |
The Ambu AuraGain laryngeal mask airway (Ambu A/S, Ballerup Denmark) is a newer secondgeneration supraglottic airway device launched in June 2014. It is a single use SAD made of
polyvinylchloride (PVC) and is anatomically curved to follow the human airway and promises to
provide high seal pressures [Figure 1]. In addition, it has an integrated gastric access, a bite block,
and a wider airway tube and can be used as conduit for direct blind intubation and fiberoptic
guided intubation |
| Comparator Agent |
I-GEL |
The i-gelTM is a single use supraglottic airway which does not have an inflatable cuff. I gelTM is composed of a soft, gel-like, non-inflatable cuff made of a thermoplastic elastomer. The stem of
the i-gelTM is less flexible than that of the LMA-classic and has an integral bite.
i-gelTM has also been used in rescue airway management and as a conduit for blind tracheal intubation and fibreoptic guided intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
BELONGING TO ASA PHYSICAL STATUS I OR II. |
|
| ExclusionCriteria |
| Details |
Patients with pregnancy, known or
predicted difficult airway, reduced lung
compliance, inter incisor gap < 3.0cm, BMI
>35 kg/m2
, High risk for pulmonary aspiration
(non fasted, gastroesophageal reflux disease).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare success rate of blind endotracheal intubation through i-gelTM & Ambu AuraGain. |
48weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare success rate of device [SAD] insertion [Number of insertion attempts, time of
insertion].
2. Postoperative complications.
Blood on device.
Sore throat.
Hoarseness of voice.
Dysphagia |
2 YEARS |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/10/2023 |
| 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)
|
Open to Recruitment |
| 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
|
The Ambu AuraGain laryngeal mask airway (Ambu A/S, Ballerup Denmark) is a newer secondgeneration supraglottic airway device launched in June 2014. It is a single use SAD made of polyvinylchloride (PVC) and is anatomically curved to follow the human airway and promises to provide high seal pressures [Figure 1]. In addition, it has an integrated gastric access, a bite block, and a wider airway tube and can be used as conduit for direct blind intubation and fiberoptic guided intubation. The purpose of this study is to compare the blind endotracheal intubation 2 through i-gelTM and Ambu AuraGain in adults in elective surgery. |