| CTRI Number |
CTRI/2025/11/097384 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Accidental Removal of Breathing Tubes in Children: A Comparison of Nose and Mouth Placement in Intensive Care |
|
Scientific Title of Study
|
Incidence Of Unplanned Extubation In Nasotracheal vs Orotracheal Intubation In a Paediatric Intensive Care Unit : An Open Labelled Randomized Controlled Trial |
| Trial Acronym |
UENOIP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AMLAN JAIN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS RAIPUR |
| Address |
ROOM 306,INTERN BOYS HOSTEL,AIIMS RAIPUR,TATIBANDH RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
7424903120 |
| Fax |
|
| Email |
amlanjain19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MANAS RANJAN SAHOO |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of PEDIATRICS, AIIMS RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
7893230151 |
| Fax |
|
| Email |
drmrsahoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MANAS RANJAN SAHOO |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of PEDIATRICS, AIIMS RAIPUR
CHHATTISGARH
492099
India |
| Phone |
7893230151 |
| Fax |
|
| Email |
drmrsahoo@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RAIPUR |
| Address |
All India Institute of Medical Sciences, Raipur, Tatibandh , GE Road, Raipur, Chhattisgarh,492099 |
| 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 AMLAN JAIN |
AIIMS RAIPUR |
PICU, C BLOCK, 2nd floor, Hospital Building, AIIMS Raipur, Tatibandh,492099
Raipur
CHHATTISGARH |
7424903120
amlanjain19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasotracheal Intubation |
Nasotracheal intubation is a method of placing a breathing tube through the nose instead of the mouth to help a sick child breathe, especially in the ICU. One of the main advantages is that the tube stays more secure and is less likely to be accidentally pulled out, which is very helpful in children who may move around or pull it. It is also more comfortable for the child, as it avoids the mouth and causes less gagging or discomfort. This method can reduce secretions in the mouth and makes feeding and mouth care easier |
| Comparator Agent |
Orotracheal Intubation |
Orotracheal intubation involves placing a breathing tube through the mouth into the windpipe to help a sick child breathe, especially in the ICU. It is the most commonly used technique in emergency and critical care because it is quicker and easier to perform when time is crucial. A key advantage is that it allows the use of a larger tube than the nasal route, providing more effective breathing support. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 3 month to 14 years admitted in PICU, intubated at any point of time during the PICU stay. |
|
| ExclusionCriteria |
| Details |
Known bleeding disorder, Raised intracranial pressure, Already tracheostomized patient, Structural malformation,Nasal trauma, Already intubatedmore than 24 hours at the time of admission to PICU, Consent denial
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare unplanned extubation rates between nasotracheal intubation group and orotracheal intubation group |
72 hours after successful extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts required for successful intubation in both groups |
not applicable |
| Complications during intubation |
10 minutes post intubation |
| Incidence of post extubation stridor in both groups |
72 hours post extubation |
| Duration of ventilated days in both groups |
48 hours after removing ventilator support |
| Incidence of Ventilator associated pneumonia between the two groups |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="202"
Sample Size from India="202"
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)
|
26/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Unplanned
extubation defined as the unintended removal of an endotracheal tube by a
patient, is a significant clinical challenge in pediatric intensive care units
(PICUs). It can lead to serious consequences such as hypoxemia, airway trauma,
increased need for sedation, emergency reintubation, prolonged mechanical
ventilation, and extended PICU stays. These complications not only pose
clinical risks but also increase healthcare costs and resource utilization.This study
seeks to address this gap by comparing the incidence of unplanned extubation
between nasotracheal and orotracheal intubation in children admitted to the
PICU, aiming to inform clinical decision-making and improve patient outcomes. |