| CTRI Number |
CTRI/2022/01/039483 [Registered on: 17/01/2022] Trial Registered Prospectively |
| Last Modified On: |
14/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Safety of sedation with and without prophylactic placement of nasopharyngeal airway in children during MRI |
|
Scientific Title of Study
|
A prospective, randomized study comparing the safety of sedation with and without prophylactic placement of nasopharyngeal airway in children undergoing MRI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gita Nath |
| Designation |
Consultant |
| Affiliation |
Rainbow Childrens Hospital |
| Address |
Anaesthesia department
4th floor
Road no 2, Banjara Hills, Hyderabad
Anaesthesia department
4th floor
Road no 2, Banjara Hills, Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
09000241012 |
| Fax |
|
| Email |
drgitanath@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gita Nath |
| Designation |
Consultant |
| Affiliation |
Rainbow Childrens Hospital |
| Address |
Road no 2, Banjara Hills, Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
09000241012 |
| Fax |
|
| Email |
drgitanath@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Beesam |
| Designation |
Fellow, Paediatric Anaesthesia |
| Affiliation |
Rainbow Childrens Hospital |
| Address |
Anaesthesia department
4th floor
Road no 2, Banjara Hills, Hyderabad
Anaesthesia department
4th floor
Road no 2, Banjara Hills, Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9640428080 |
| Fax |
|
| Email |
beesamshruti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rainbow Childrens Hospital, Hyderabad |
|
|
Primary Sponsor
|
| Name |
Rainbow Childrens Hospital |
| Address |
Road no 2, Banjara Hills, Hyderabad |
| Type of Sponsor |
Other [Corporate 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 |
| Gita Nath |
Rainbow Childrens Hospital |
Road no 2
Banjara Hills
Hyderabad
Hyderabad
TELANGANA |
9000241012
drgitanath@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rainbow Children s Hospital EC for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Prophylactic placement of nasopharyngeal airway |
Children in group A will receive sedation followed by placement of a nasopharyngeal airway prophylactically |
| Comparator Agent |
Sedation without prophylactic airway adjunct |
Sedation without prophylactic airway adjunct. Airway management will be done as necessary |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged 0-18 years scheduled for an MRI for diagnostic purposes |
|
| ExclusionCriteria |
| Details |
1.Patients >18 years of age
2. Premature neonates
2. Patients who are already intubated
3. Critically ill patients
4. Patients with nasal or cranio-facial fractures in whom placement of airway adjunct is contraindicated
5. Patients with anticipated difficult airway
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of airway related adverse events |
At the end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total dose of the propofol given |
At the end of procedure |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/02/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Children requiring MRI under sedation will be randomized to either have a prophylactic airway inserted or alternatively, routine airway management. The number of airway events, interventions and dose of propofol will be compared between groups. |