| CTRI Number |
CTRI/2023/09/057881 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different insertion techniques of supraglottic airway device named Air-q in pediatrics surgery by mean of fibreoptic assessment |
|
Scientific Title of Study
|
Comparison of Fiber-optic Assessment in Midline versus Rotatioanl Insertion Technique of Air-Q in pediatricsSurgeries;aRandomisedDouble Blind Interventional Study in Department of Anaesthesiology ,SMS Medical college and Hospital Jaipur |
| 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 Rama chatterjee |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh medical college Jaipur |
| Address |
Department of Anaesthesiology,2nd floor,Dhanvantri complex,Sawai Man Singh medical college,jaipur,Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828622026 |
| Fax |
|
| Email |
chatterjeerama30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rama Chatterjee |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh medical college Jaipur |
| Address |
Department of Anaesthesiology,2nd floor,Dhanvantri complex,Sawai Man Singh medical college,jaipur,Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828622026 |
| Fax |
|
| Email |
chatterjeerama30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amandeep Kaur |
| Designation |
Junior resident |
| Affiliation |
SMS medical college Jaipur Rajasthan |
| Address |
Department of Anaesthesiology,2nd floor dhanvantri complex,SMS medical college Jaipur,Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8852919206 |
| Fax |
|
| Email |
dr.amanbalian@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology second floor Dhanvantri complex Sawai Man Singh medical college Jaipur Rajasthan |
|
|
Primary Sponsor
|
| Name |
SMS medical college Jaipur, Rajasthan |
| Address |
Department of Anaesthesiology,2nd floor dhanvantri complex,SMS medical college Jaipur ,Rajasthan |
| 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 Amanseep Kaur |
SPINPH,SMS Medical college Jaipur |
Department of Anaeshesiology Second floor Dhanvantri complex Operation Theater S.M.S Medical College and hospital Jaipur Rajasthan
Jaipur
RAJASTHAN |
8852919206
dr.amanbalian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of The Ethics Committee,SMS medical college and Attached hospitals, Jaipur Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
midline insertion technique of Air-Q |
fiber-optic assessment in midline insertion technique of Air-Q in pediatric surgeries a randomised double blind interventional study
Once Total duration of device -Till completion of surgery |
| Comparator Agent |
rotational insertion technique of Air-Q |
fiber-optic assessment in rotational insertion technique of Air-Q in pediatric surgeries -a randomised double blind interventional study-Once Total duration of device -Till completion of surgery |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
a. A.S.A. I and II
b. Age range between 5 years to 12 years.
c. Weight between 10 to 30 kg
d. Elective inguinal, urological procedures for which SADs are routinely used.
e. Parents or caregiver willing to participate in study.
|
|
| ExclusionCriteria |
| Details |
a. Patient with acute upper respiratory iinfection.
b. Patient with difficult airway.
c. Surgery time more than one hrs.
d. Emergency surgeries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Mean grading of fibre-optic bronchoscopic assessment of laryngeal view through Air-Q.
2.Mean Time of Insertion
3.Mean Score of ease of Insertion
4.Mean Number of attempts
|
mean time of insertion of AIR-Q insertion(in seconds) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Number of patients showing post operation complications like sore throat, cough, laryngospasm, & trauma (blood on the device after removal |
1.sore throat
2 cough 3.laryngospasm & trauma (blood on the device after remova |
| Mean Number of patients showing post operation complications like sore throat, cough, laryngospasm, & trauma (blood on the device after removal of device) |
Intraoperative Hemodynamic Monitoring
baseline
Post induction(1 minute)
After insertion of Air-Q (immediatly)
1 mintue
2 mintue
5 mintue
10 mintue
15 mintue
20 mintue
30 mintue
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
30/09/2023 |
| 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="0"
Months="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 anatomical difference in pediatric airway could complicate the proper placement of supraglottic airway device. The pediatric airway is different from adult in some features as they have large tongue , high larynx , lack of teeth and short neck. Therefore, it is prerequisite to assess the technique to improve positioning of Air-Q as improper position can cause laryngeal obstruction and inadequate seal. The fibre-optic bronchoscopy helps in assessing the position of Air-Q. There are very few studies of comparison of fibre-optic bronchoscopic assessment of laryngeal view indifferent techniques of Air-Q in pediatric patient so this study is planned to compare fibre-optic bronchoscopic assessment of laryngeal view in different insertion techniques of Air-Q in pediatric surgeries. |