| CTRI Number |
CTRI/2024/11/076970 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Assisted Breathing modes to stomach inflation in children
|
|
Scientific Title of Study
|
Comparison of gastric insufflation with pressure and volume controlled face mask ventilation 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 Anusha Manikyam |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Anaesthesia office
Department of Anaesthesiology and Intensive care
Level 4, Nehru Hospital, PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9182422442 |
| Fax |
|
| Email |
manikyamanusha24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Jain |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Anaesthesia office
Department of Anaesthesiology and Intensive care
Level 4, Nehru Hospital, PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
985590071 |
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Jain |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Anaesthesia office
Department of Anaesthesiology and Intensive care
Level 4, Nehru Hospital, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
985590071 |
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical science and Research, Chandigarh,160012 |
|
|
Primary Sponsor
|
| Name |
Dr Anusha Manikyam |
| Address |
Department of Anaesthesiology and Intensive care, level 4 , Nehru hospital, Chandigarh, 160012 |
| 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 anusha manikyam |
Post graduation institute of education and research |
Department of Anesthesia, Pediatric Anesthesia,Nehru block
Chandigarh
CHANDIGARH |
9182422442
manikyamanusha24@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 |
| Intervention |
Pcv group |
Patient will be put on PCV during face mask ventilation for 4min till intubation at PIP(peak inspiratory pressure) of 8-12 cm of H20 and PEEP of 0 cm of H20,and respiratory rate of 16-18/min |
| Comparator Agent |
Vcv group |
Patient will be put on VCV mode during face mask ventilation for 4min till intubation, at tidal volume of 6-8ml/kg and at respiratory rate of 16-18/min and 0 PEEP |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS- 1 and 2, aged between 1-3years, of either gender undergoing elective surgery, after parent/guardian consent would be enrolled |
|
| ExclusionCriteria |
| Details |
Anticipated difficult face mask ventilation
Parents refusal
Underlying respiratory or gastric disease
Inadequate fasting status
Those requiring rapid sequence intubation
Those with a nasogastric tube insitu
|
|
|
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 incidence of Gastric insufflation during pressure controlled and volume controlled face mask ventilation |
immediately after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| gastric antral area |
preoperative room and after intubation |
| Hemodyanamic parameters including mean arterial pressure and heart rate |
At 1min, 2min, 3 min, 4 min and post intubation |
| Ventilation parameters including peak airway pressures, inspired tidal volume, expired tidal volume, minute ventilation |
at 1min, 2min, 3 min, 4 min and post intubation |
| Respiratory parameters including end tidal carbon dioxide, oxygen saturation |
at 1min, 2min, 3 min, 4 min and post intubation |
| any desaturation, inability to ventilate, episodes of vomiting or regurgitation |
induction to after intubation |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 4 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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 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 - NO
|
|
Brief Summary
|
Face mask ventilation is a basic skill and is especially more important in children as they are more prone to hypoxia related injuries. Gastric insufflation is a known side effect during face mask ventilation , and children are at risk due to their shorter esophagus and lower LES tone, can lead to backflow of stomach contents leading to pulmonary and hemodynamic complications. Gastric ultrasound is found superior to other methods to look for insufflation. There is currently no evidence indicating PCV superior to VCV regarding gastric insufflation in children, therefore we aim to conduct a prospective randomized trial comparing PCV with VCV, with respect to gastric insufflation and adequacy of ventilation. children meeting both inclusion and exclusion criteria will be taken. Preoperatively , gastric u;trasoung will be done, after standard induction process , facemask ventilation will be done for 4 minutes in either of the two modes of ventilation either VCV or PCV . respiratory, hemodynamic and ventilaory parameters will be monitored every min till intubation. Insufflation will be seen by either comet tail appearance or acoustic shadow on gastric ultrasound and antra area is also taken post intubation. incidence of gastric insufflation will be calculated ass the primary outcome and antral area difference and repiratory, hemodynamic and ventilatory parameters are compared as secondary outcomes.
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