| CTRI Number |
CTRI/2025/08/092257 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Optimal flow rate for Apnoeic oxygenation to achieve firstpass success in pediatric anticipated difficult Intubations prospective study |
|
Scientific Title of Study
|
Optimal flow rate for Apnoeic oxygenation to achieve firstpass success in pediatric anticipated difficult Intubations prospective study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shobana |
| Designation |
Postgraduate student |
| Affiliation |
Meenakshi Mission Hospital and Research centre |
| Address |
Lake area melur road
Madurai
Madurai
TAMIL NADU
625107
India |
| Phone |
8838190343 |
| Fax |
|
| Email |
drsonashobana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
shobana |
| Designation |
Postgraduate student |
| Affiliation |
Meenakshi Mission Hospital and Research centre |
| Address |
Lake area melur road madurai
Madurai
Madurai
TAMIL NADU
625107
India |
| Phone |
8838190343 |
| Fax |
|
| Email |
drsonashobana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
shobana |
| Designation |
Doctor |
| Affiliation |
Meenakshi Mission Hospital and Research centre |
| Address |
66,Bharathi nagar main road
Krishnapuram colony
Madurai
TAMIL NADU
625014
India |
| Phone |
8838190343 |
| Fax |
|
| Email |
drsonashobana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
none |
| Address |
meenakshi mission hospital and research centre |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| shobana |
meenakshi mission hospital and research centre |
Fifth floor, department of smile train operation theatre, mmhrc, lake view road
madurai
Madurai
TAMIL NADU |
08838190343
drsonashobana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics commitee |
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 |
flow of oxygen through nasal airway 0.5 litre per kg vs hfnc nasal cannula 2 litre per kg |
comparision between flow of oxygen through nasal airway 0.5 litre per kg vs hfnc nasal canula 2 litre per kg and obtain first pass intubation success |
| Intervention |
oxygen through nasal airway vs hfnc nasal canula |
nasal airway oxygen flow rate will be compared with hfnc oxygen flow |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
All pediatric patients of weight 5 to 20 kg
Scheduled for endotracheal intubation under general anesthesia
Identified as having an anticipated difficult airway, based on standardized criteria (e.g., congenital craniofacial anomalies, limited mouth opening, reduced neck mobility, history of previous difficult intubation)
Hemodynamically stable prior to induction
Consent obtained from parent or legal guardian |
|
| ExclusionCriteria |
| Details |
not giving consent, hemodynamically unstable |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the optimal Flowrate for Apnoeic Oxygenation in pediatric anticipated difficult intubations. |
Time from starting Intubation, ( stopping bag mask ventilation ) to successfull first breath after intubations. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the impact of apnoeic oxygenation in first-pass intubation success rates. |
Time from starting Intubation, ( stopping bag mask ventilation ) to successfull first breath after intubations.
|
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
13/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response (Others) - nil
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - journals or publications
- For how long will this data be available start date provided 01-11-2025 and end date provided 31-12-2034?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
To find the optimal Flowrate for Apnoeic Oxygenation to achieve first-pass success in pediatric anticipated difficult intubations. By evaluating the optimal flowrate, excessive oxygen usage can be avoided and to find ,in which method, co2 retention is minimal. To find the optimal Flowrate for Apnoeic Oxygenation in pediatric anticipated difficult intubations with minimal co2 retention . and To find the impact of apnoeic oxygenation in first-pass intubation success rates. by comparing HFNC flow with Nasal aiway flows. |