| CTRI Number |
CTRI/2017/10/010240 [Registered on: 30/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
27/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study of blind tracheal intubation through three supraglottic airway devices: ILMA(Intubating Laryngeal Mask Airway),I-Gel and Ambu AuraGain in adults. |
|
Scientific Title of Study
|
Comparative evaluation of three supraglottic airway devices: ILMA(Intubating Laryngeal Mask Airway),I-Gel and Ambu AuraGain for blind tracheal intubation in adults. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riniki Sarma |
| Designation |
post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 25, Lok Nayak resident doctors hostel (LNRDH), Maulana Azad Medical College, Bahadur Shah Zafar marg, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8447456976 |
| Fax |
|
| Email |
riniki_rs@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar |
| Designation |
Supervisor/ Guide |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 302, Department of Anesthesiology and critical care,3rd floor, B.L.Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar marg, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604214 |
| Fax |
|
| Email |
rakeshrampal@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riniki Sarma |
| Designation |
post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 25, Lok Nayak resident doctors hostel (LNRDH), Maulana Azad Medical College, Bahadur Shah Zafar marg, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8447456976 |
| Fax |
|
| Email |
riniki_rs@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, Bahadur shah Zafar marg, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Lok Nayak Hospital |
| Address |
Lok Nayak Hospital,Bahadur Shah Zafar Marg, New Delhi-110002 |
| 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 |
| Riniki Sarma |
Lok Nayak hospital |
Room no 302,Department of anesthesiology and critical care, B.L.Taneja block, Maulana Azad Medical College Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi
DELHI |
8447456976
riniki_rs@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group IL, group IG, group AG |
Group IL- patients where ILMA was used for blind tracheal intubation
Group IG- patients where Igel was used for blind tracheal intubation
Group AG- patients where Ambu auragain was used for blind endotracheal intubation |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
18-65yrs age; ASA1,2,3; Mallampalli class 1-2; thyromental distance more than 6cm; inter incisor gap more than 3cm; range of neck movement more than 90degree; Bmi less than 30kg/m2 |
|
| ExclusionCriteria |
| Details |
Pregnant patients; congenital or acquired airway abnormality; patients with increased risk of aspiration; patients with GERD |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful intubation in first attempt |
All successful blind intubation after 1 attempt |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall successful intubation in two attempts |
All successful blind intubation after 2 attempts |
| Time of insertion in successful attempt |
Time required for successful intubation in 1st or 2nd attempt |
| Ease of insertion of device and endotracheal tube |
After successful insertion of device and endotracheal tube |
| Post operative complications |
post operatively after 2 hours and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "95"
Final Enrollment numbers achieved (India)="95" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2015 |
| Date of Study Completion (India) |
30/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title- Comparative evaluation of three supraglottic airway devices: intubating laryngeal mask airway (ILMA), I-gel and Ambu AuraGain for blind tracheal intubation in adults.
Background- Although fibreoptic endoscopy is the method of choice for tracheal intubation through a supraglottic airway device (SAD), a fibrescope may not always be available. Hence, there is need to evaluate the SADs for blind tracheal intubation through these. Our study assesses three supraglottic airway devices, intubating laryngeal mask airway (ILMA), i-gel and Ambu AuraGain for blind tracheal intubation in adults
Materials and methods- After taking instituitional review board approval, this prospective randomised study was conducted in the department o f anesthesiology, MAMC and associated Lok Nayak Hospital, New Delhi. Ninety adults undergoing elective surgery under general anaesthesia was randomised into three equal groups. After a standardised induction of anesthesia, the group specific SAD was inserted and on achieving adequate ventilation with the device, blind tracheal intubation was attempted. Success rates of blind tracheal intubation through the SADs, ease of device and ET tube insertion and post operative complications (secondary outcome criteria) were evaluated. Data were analysed using SPSS version 17.0 and p<0.05 was considered statistically significant.
Results- There was no difference in the incidence of adequate ventilation with any of the SAD. The success rate of tracheal intubation in 1st attempt was 86.67% in ILMA group and 26.67% in i-gel group. The success rate of tracheal intubation was 100% in ILMA group and 40% in i-gel group after both the attempts. It was not possible to intubate through Ambu auraGain in both attempts. Time taken for successful tracheal intubation in ILMA and i-gel did not differ significantly (p value=0.205). Post operative complications also did not differ significantly in the three groups.
Conclusion- Out of the three, ILMA is the best device for blind tracheal intubation.
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