| CTRI Number |
CTRI/2026/01/101767 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out if using a small amount of air pressure (called PEEP – about 5 cm of water pressure) can help young children, aged 2 to 6 years, hold their breath safely for longer and prevent parts of their lungs from collapsing during the start of general anaesthesia before surgery. |
|
Scientific Title of Study
|
The effect of positive end expiratory pressure during anaesthesia induction on non hypoxic apnoea time in paediatric patients posted for surgeries under general anaesthesia;A randomized control trial |
| Trial Acronym |
. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AISWARYA.S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JN medical college Nehru nagar,Belagavi,Karnataka |
| Address |
Department of Anaesthesiology,KLES Dr Prabhakar Kore Hospital and Medical Research Centre,Jawaharlal Nehru Medical College campus,Nehru Nagar,Belagavi
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
7306913785 |
| Fax |
|
| Email |
aiswaryaenathu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Rajesh Mane |
| Designation |
Head of department |
| Affiliation |
JNmedical college,Nehru nagar,Belagavi, Karnataka |
| Address |
Head of department
Department of anaesthesia
JN medical college,Nehru nagar,Belagavi,Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9844131062 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Rajesh Mane |
| Designation |
Head of department |
| Affiliation |
JNmedical college,Nehru nagar,Belagavi, Karnataka |
| Address |
Head of department
Department of anaesthesia
JN medical college,Nehru nagar,Belagavi,Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9844131062 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,KLES Dr Prabhakar Kore Hospital and Medical Research Centre,Jawaharlal Nehru Medical College campus,Nehru Nagar,Belagavi
Belgaum
Karnataka
Pincode-590010
India |
|
|
Primary Sponsor
|
| Name |
AiswaryaS |
| Address |
Department of Anaesthesiology,KLES Dr Prabhakar Kore Hospital and Medical Research Centre,Jawaharlal Nehru Medical College campus,Nehru Nagar,Belagavi
Belgaum
Karnataka
Pincode-590010
India |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DrAISWARYAS |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of Anaesthesiology,KLES Dr Prabhakar Kore Hospital and Medical Research Centre,Jawaharlal Nehru Medical College campus,Nehru Nagar,Belagavi
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA |
7306913785
aiswaryaenathu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0cmH2O |
Patients receiving 0cmH20 PEEP during anaesthesia induction |
| Intervention |
5cmH20 PEEP |
Patients receiving 5cmH20 PEEP during anaesthesia induction |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric age group of 2-6 years old, scheduled for elective surgeries under general endotracheal anaesthesia will enroll in the study after obtaining their written informed consent from the parent/guardian. |
|
| ExclusionCriteria |
| Details |
Children with known pulmonary or cardiac disease.
History of recent upper respiratorytract infection
Anticipated difficult intubation/mask ventilation.
Emergency surgeries.
Patients whose guardian/parent declined to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of positive end expiratory pressure during anaesthesia induction on non hypoxic apnoea time in paediatric patients posted for surgeries under general anaesthesia |
0 min,1 min,3mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the incidence & severity of atelectasis in both groups using standardized
lung ultrasound scoring |
0 min,5mins |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
31/01/2026 |
| 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="0"
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
|
This study wants to find out if using a small amount of air pressure (called PEEP – about 5 cm of water pressure) can help young children, aged 2 to 6 years, hold their breath safely for longer and prevent parts of their lungs from collapsing during the start of general anaesthesia before surgery.The study compares using this small pressure to using no extra pressure at all, to see which works better. The child will be given oxygen through a face mask for 3 minutes, with the machine carefully controlling the amount of air. After 3 minutes of breathing with the mask, a breathing tube will be gently placed into the child’s windpipe (trachea), and then the breathing machine will be briefly disconnected to begin the breath-holding part of the procedure. Right after the child starts breathing again, doctors will use an ultrasound (a safe scan using sound waves) to check the lungs |