| CTRI Number |
CTRI/2026/02/102697 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of filling of air in stomach with and without the use of a device called-oropharyngeal airway during anesthesia in children |
|
Scientific Title of Study
|
Effect of oropharyngeal airway on gastric insufflation during anesthetic induction in children- a randomized controlled 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 |
Dr Mariyam Hudha |
| Designation |
Junior Resident, Department of Anaesthesiology, Kasturba Medical College, Manipal |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesia, Kasturba Medical College, Manipal, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
7349765949 |
| Fax |
|
| Email |
mrym_hudha@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Sara Mundappallil Jacob |
| Designation |
Associate Professor, Department of Anaesthesiology, Kasturba Medical College, Manipal |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesia, Kasturba Medical College, Manipal, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9500574751 |
| Fax |
|
| Email |
nishasara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mariyam Hudha |
| Designation |
Junior Resident, Department of Anaesthesiology, Kasturba Medical College, Manipal |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesia, Kasturba Medical College, Manipal, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
7349765949 |
| Fax |
|
| Email |
mrym_hudha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Manipal Academy of Higher Education,
Tiger circle road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576194 |
|
|
Primary Sponsor
|
| Name |
Dr Mariyam Hudha |
| Address |
Department of Anaesthesia, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Udupi, Karnataka, 576104 |
| 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 |
| Dr Mariyam Hudha |
Kasturba Medical College, Manipal |
Room number 1 , 1st floor , Department of Anaesthesia, Kasturba Medical College, Manipal, Manipal Academy of Higher Education,Madhav nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
7349765949
mrym_hudha@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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 |
No oropharyngeal airway |
No oropharyngeal airway will be inserted into oral cavity of child, in the comparator group during induction of anesthesia. Instead child will be ventilated without the oro-pharyngeal airway |
| Intervention |
Oropharyngeal Airway |
An oropharyngeal airway will be inserted into oral cavity of child, during induction of anesthesia as part of intervention |
|
|
Inclusion Criteria
|
| Age From |
15.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group: children more than 60 weeks (post conceptional age)
2) Weight less than 30kg
3) American Society of Anesthesiologists (ASA) Physical status (PS) I and II status
4)Children undergoing elective surgery under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1) Full stomach status
2) Anticipated difficult mask ventilation
3) Contraindication for OPA insertion (oral mass)
4) Upper airway obstruction risk – grade 3 and above tonsils, symptoms of snoring or suggestive of obstructive sleep apnea (OSA)
4) Obesity (more than 95% weight for age)
5) Known underlying respiratory disease or neurological disease
6) Known underlying significant cardiac 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 |
To estimate the effect of OPA on gastric insufflation during anaesthetic induction in paralyzed children for elective surgery under general anesthesia
|
every month for one year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a) Determine the appropriate level of inspiratory pressure sufficient to provide adequate ventilation with or without an OPA a during facemask pressure-controlled ventilation |
every 2 months for one year |
| b) To compare time for appearance of comet tail on real time ultrasound (USG) between the two groups |
every 2 months for 1 year |
| To compare hemodynamic parameters and ventilatory parameters between the two groups. |
every 2 months for one year |
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
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)
|
01/04/2026 |
| 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="0"
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
|
Gastric insufflation (GI) is a known complication of facemask
ventilation during anaesthetic induction, particularly in paediatric patients.
During this process, the application of positive pressure may inadvertently
direct gas into the stomach, leading to risks such as aspiration, impaired
ventilation, and increased intragastric pressure. Despite
the use of pressure-controlled ventilation (PCV) techniques designed to limit
peak airway pressures, the risk of GI persists. The oropharyngeal
airway (OPA) is a simple adjunct that may help mitigate GI by maintaining upper
airway patency and reducing resistance during facemask ventilation. However,
few studies have directly assessed its impact on GI during anaesthetic
induction in children. This study seeks to bridge a significant knowledge gap
by evaluating whether the use of an oropharyngeal airway can reduce the
incidence of gastric insufflation during pressure-controlled mask ventilation
in paralyzed paediatric patients. The secondary outcomes investigated are as follows: a) Determine
the appropriate level of inspiratory pressure sufficient to provide adequate ventilation
with or without an OPA a during facemask pressure-controlled ventilationb) To
compare time for appearance of comet tail on real time US between the two
groups
c) To
compare hemodynamic parameters and ventilatory parameters between the two
groups. |