| CTRI Number |
CTRI/2023/06/053354 [Registered on: 01/06/2023] Trial Registered Prospectively |
| Last Modified On: |
31/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of endotracheal tube placement using Ambu Aura 40 versus Ambu Aura i" supraglottic devices as conduit |
|
Scientific Title of Study
|
"A study to assess Supraglottic Airway Device guided endotracheal tube placement using Ambu Aura 40 versus Ambu Aura i" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Kumar |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology and critical care, Pt B.D Sharma PGIMS, Rohtak Haryana |
| Address |
Department of Anaesthesiology and critical care, Pt B.D Sharma PGIMS, Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9416336901 |
| Fax |
|
| Email |
pk.pgims@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Kumar |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology and critical care, Pt B.D Sharma PGIMS, Rohtak Haryana |
| Address |
Department of Anaesthesiology and critical care, Pt B.D Sharma PGIMS, Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9416336901 |
| Fax |
|
| Email |
pk.pgims@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha |
| Designation |
Post graduate resident |
| Affiliation |
Department of Anaesthesiology and critical care, Pt B.D Sharma PGIMS, Rohtak Haryana |
| Address |
Department of Anaesthesiology and critical care, Pt B.D Sharma PGIMS, Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7082700162 |
| Fax |
|
| Email |
93yadavnisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and critical care PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak |
| Address |
Rohtak Haryana |
| 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 Nisha |
Pt ,B.D.Sharma PGIMS ,Rohtak |
Depatment of anaesthesiology and critical care ,PGIMS Rohtak
Rohtak
HARYANA |
7082700162
93yadavnisha@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ease and sucess of intubation through SAD Ambu Aura i in patients receiving general anaesthesia |
Ambu Aura i is designed for both ventilation and as aconduit for tracheal intubation. maximum 3 attempts will be allowed for passage of tube thru supraglottic device, expected within 30 seconds |
| Comparator Agent |
To evaluate the ease and success of ET tube placement using ambu aura 40 in patients receiving general anaesthesia |
Ambu Aura 40 has not been tried for intubation till date but the dynamics of the devicemake it that it can be used for endotracheal intubation because of wider shaft ,angulation and no aperture bar |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Sixty adult patients aged between 18-60 years of either sex of ASA grade I and II scheduled for elective surgery requiring general anaesthesia will be included |
|
| ExclusionCriteria |
| Details |
patients refusing to participate,having respiratory or pharyngeal pathology,mouth opening <2.5 cms ,body mass index>30kgm²
,pregnancy,full stomach,suspected difficult airway will be excluded |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the ease and success of endotracheal tube placement through ambu aura 40 versus.ambu aura i. maximum of 3 attempts. expected to be within 30 seconds |
time for insertion of device(within 10 sec), Time for insertion of tube (within 20 sec), Hemodynamic parameters at Baseline, At time of induction, at supraglottic insertion, At Tube insertion, after 5 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for placement of SAD and intubation through SAD
Position of SAD confirmed with Fiberoptic
Number of attempts of SAD and intubation through SAD
Variation in hemodynamic variables
Post procedure complications |
insertion time of SAD (sec)
insertion time of endotracheal tube (sec)
hemodynamic parameters at minute and 5 minutes
post procedure complication at immediate postoperative,after half an hour and after one hour |
|
|
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)
|
10/06/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective ,randomised , single blinded study will be conducted in the Department of Anaesthesiology and Critical Care,Pt.B.D.Sharma PGIMS,Rohtak . Sixty patients of either sex aged 18 to 60 years belonging to ASA Grade 1 and 2 undergoing surgical procedures requiring intubation will be included in this study.All the patients will be examined pre operatively and details of the clinical history ,general physical examination and systemic examination will be recorded . Detailed examination of the patients will be carried out for any neck mass ,any loose tooth,mouth opening .Routine investigations like hemoglobin,bleeding time,clotting time and complete urine examination will be carried out in all the patients .Any other relevant investigation like blood urea ,srum creatinine ,serum electrolytes, chest x-ray and ECG will be done as and when required.Patient will be explained about the procedure and written and informed consent will be obtained for participation in the study. |