| CTRI Number |
CTRI/2018/09/015574 [Registered on: 04/09/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of insertion techniques of air-Q intubating laryngeal airway by fiberoptic bronchoscopic assessment in paediatric patients |
|
Scientific Title of Study
|
Fiberoptic assessment of air-Q position- comparison of insertion techniques in paediatric age group |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manasa Gaddam |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care,Level 4,Nehru Hospital,PGIMER,Chandigarh-160012
Roon no: S-46,Sanjeevini girls hostel,PGIMER,Sector-12,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872445559 |
| Fax |
|
| Email |
manu.grsn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Sethi |
| Designation |
Additional Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,Level 4,Nehru Hospital,PGIMER,Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9317851002 |
| Fax |
|
| Email |
sameersethi29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manasa Gaddam |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care,Level 4,Nehru Hospital,PGIMER,Chandigarh-160012
Roon no: S-46,Sanjeevini girls hostel,PGIMER,Sector-12,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872445559 |
| Fax |
|
| Email |
manu.grsn@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care,Level 4,Nehru Hospital,PGIMER,Chandigarh-160012 |
| 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 |
| MANASA GADDAM |
PGIMER |
Department of Anaesthesia and Intensive Care,Level 4,Nehru hospital,PGIMER,Chandigarh-160012
Chandigarh
CHANDIGARH |
8872445559
manu.grsn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee.PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I/II Paediatric patients undergoing surgeries of shorter duration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fiberoptic assessment of Air-Q |
Fibreoptic assessemnt of air-Q position -comparison of insertion techniques(midline and rotational insertion techniques) |
| Intervention |
Fibreoptic |
Fibreoptic assessemnt of air-Q position -comparison of insertion techniques(midline and rotational insertion techniques) |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA I or II
Weight between 10-30 kg
Undergoing elective surgeries in supine position requiring general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Upper respiratory tract infection (cough, fever, rhinorrhea) at the day of surgery.
2. Respiratory tract pathology ( oropharynx, larynx )
3. Anticipated difficult airway
4. Children at increased risk of aspiration - Gastro esophageal reflux disease, non fasting status
5. Hiatus hernia
6. Lung diseases
7. Cardiorespiratory or cerebrovascular disease
|
|
|
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 |
| Fiberoptic assessment of air-Q position using two insertion techniques i.e. midline technique and rotational technique |
Immediately after insertion of air-Q |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of attempts for successful air-Q insertion 2. Time taken for insertion
3. Oropharyngeal leak pressure
4. Occurrence of complications such as trauma, laryngospasm, and hypoxemia (Spo2 90%)
|
During insertion of air-Q
Immediately after insertion of air-Q
After removal of air-Q |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2016 |
| Date of Study Completion (India) |
15/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/09/2016 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Darlong V, Biyani G, Baidya DK, et al. Comparison of air-Q and Ambu Aura-i for
controlled ventilation in infants: a randomized controlled trial. Paediatr Anaesth. 2015
Aug; 25: 795-800.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We will be comparing midline and rotational insertion techniques of air-Q immediately using fiberoptic bronchoscopy.Parameters assessed include fiberoptic bronchoscopic grading of air-Q position,ease of insertion,time taken to insert, haemodyanmic changes during insertion and complications if any. |