| CTRI Number |
CTRI/2020/09/027981 [Registered on: 23/09/2020] Trial Registered Prospectively |
| Last Modified On: |
22/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of two supraglottic airway devices for blind tracheal intubation |
|
Scientific Title of Study
|
A Comparative study of Ambu Aura-i and Air-Q Supraglottic airway devices as conduit for blind tracheal intubation in patients with normal airway |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Afroza Syed |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Baroda |
| Address |
Baroda medical college, Vinobha bhave road, Anandpura, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825359856 |
| Fax |
|
| Email |
afroza7887@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Afroza Syed |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Baroda |
| Address |
Baroda medical college, Vinobha bhave road, Anandpura, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825359856 |
| Fax |
|
| Email |
afroza7887@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Afroza Syed |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Baroda |
| Address |
Baroda medical college, Vinobha bhave road, Anandpura, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825359856 |
| Fax |
|
| Email |
afroza7887@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baroda Medical College and SSG Hospital, Vadodara |
|
|
Primary Sponsor
|
| Name |
SSG Hospital |
| Address |
Department of Anaesthesiology, Baroda Medical College and SSG Hospital, Vinoba Bhave road, Anandpura, Vadodara |
| 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 |
| Keerti A Chitgopekar |
SSG Hospital and Baroda Medical College |
Baroda medical college, Vinobha bhave road, Anandpura, Vadodara
Vadodara
GUJARAT |
9591640075
keerti14.chitgopekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECHR-PGR |
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 |
Air-Q |
Blind tracheal intubation through Air-Q intubating laryngeal airway of size no. 3.5 and 4.5 |
| Intervention |
Ambu Aura-i |
Blind tracheal intubation through Ambu Aura-i of size no. 3 and 4 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Weight 30 - 70 kgs
ASA Physical status I/II
Patients posted for elective surgeries under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with predicted difficult airway ( mouth opening <2.5cm, Mallampati grade III & IV, limited neck extension, cervical spine problem, h/o previous difficult tracheal intubation)
Patients with recent upper respiratory tract infection
Patients with any oropharyngeal pathology
Patient with any known pulmonary disease (like Asthma) and cardiovascular diseases (like hypertension).
Obese patients with BMI >30 kg/m2
Patient with any conditions that increase the risk of gastro oesophageal regurgitation.
H/O allergy to Latex or to any drugs used in protocol
Patients not willing for participation
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| first attempt success rate of blind tracheal intubation through Ambu Aura-i and Air-Q supraglottic airway device |
At the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ease of insertion of supraglottic airway device (SAD) |
At the time of insertion of Supraglottic airway device |
| no. of attempts of insertion of SAD |
attempts at the time of SAD insertion |
| time taken for insertion of SAD |
in seconds, at the time of SAD insertion |
| no.of attempts of tracheal intubation through SAD |
attempts at the time of intubation |
| time taken for tracheal intubation through SAD |
in seconds, at the time of intubation |
| ease of tracheal intubation through SAD |
At the time of intubation through supraglottic airway device |
| overall success rate of blind tracheal intubation through Ambu Aura-i and Air-Q |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
29/09/2020 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to compare between the Ambu Aura-i and Air-Q supraglottic airway device (SAD), for use as conduit for blind tracheal intubation, in terms of ease and no. of attempts of SAD insertion, time taken for SAD insertion, ease and no. of attempts of intubation, time taken for intubation, first attempt and overall success rate of intubation, and effect on Hemodynamic parameters, when used in patients with ASA physical status I/II, with normal airway. It is a Prospective Ramdomised Clinical Study. We hypothesize that both Ambu Aura-i and Air-Q SADs are comparable in above mentioned terms. |