| CTRI Number |
CTRI/2023/04/052036 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
11/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of providing oxygen during endotracheal intubation in children. |
|
Scientific Title of Study
|
Evaluation of efficacy of apneic oxygenation during endotracheal
intubation in paediatric patients undergoing elective surgeries . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAKKENA SACHIN |
| Designation |
Junior resident in anesthesiology |
| Affiliation |
Shri B M Patil medical college |
| Address |
Department of anesthesiology,shri B M Patil medical college,hospital and research institute,Bangaramma Sajjan Campus,Vijayapura,Bijapur KARNATAKA
Bijapur
KARNATAKA
586103
India |
| Phone |
8977891237 |
| Fax |
|
| Email |
sachinmakkena0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIDYA PATIL |
| Designation |
PROFFESSOR AND HOD |
| Affiliation |
Shri B M Patil medical college hospital and research institute |
| Address |
Department of anesthesiology,shri B M Patil medical college,Bangaramma Sajjan Campus,Vijayapura,Bijapur KARNATAKA
SHRI B M PATIL MEDICAL COLLEGE,VIJAYAPURA,KARNATAKA
Bijapur
KARNATAKA
586103
India |
| Phone |
9448131260 |
| Fax |
|
| Email |
vidyapatila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VIDYA PATIL |
| Designation |
PROFFESSOR AND HOD |
| Affiliation |
Shri B M Patil medical college hospital and research institute |
| Address |
Department of anesthesiology,shri B M Patil medical college,Bangaramma Sajjan Campus,Vijayapura,Bijapur KARNATAKA
SHRI B M PATIL MEDICAL COLLEGE,VIJAYAPURA,KARNATAKA
Bijapur
KARNATAKA
586103
India |
| Phone |
9448131260 |
| Fax |
|
| Email |
vidyapatila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M patil Medical College Hospital and Research Center. |
|
|
Primary Sponsor
|
| Name |
shri B M Patil Medical college |
| Address |
shri B M Patil Medical College,Bangaramma sajjan campus,BLDE university,Vijayapura bijapur,Karnataka-586103 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Makkena Sachin |
SHRI B M PATIL MEDICAL COLLEGE |
Department of Anaesthesiology,first floor to complex,Shri B M Patil Medical College,Bangaramma Sajjan Campus,BLDE university,vijayapura bijapur-586103
Bijapur
KARNATAKA |
8977891237
sachinmakkena0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETICAL COMMITTEE BLDE(DU) |
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 |
apneic oxygenation |
providing oxygenation during apneic period during intubation. |
| Comparator Agent |
NO INTERVENTION |
patients are observed till the saturation falls to 95% and time for desaturation is noted down. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
patients admitted for elective surgeries under general anaesthesia requiring intubation.with asa grade I and II |
|
| ExclusionCriteria |
| Details |
Children undergoing dental surgeries in which nasal intubation is needed.
Patients reported nasal obstruction.
Patients who have respiratory and pulmonary diseases active or recent upper respiratory tract infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of apnoeic oxygenation in prolonging the time for desaturation to occur to 95%. |
every minute for first 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To increase the safe apnoeic time so that situations requiring more time to secure the airway can be managed effectively, without critical drop in oxygen
saturation.
|
every minute for first 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
10/05/2023 |
| 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="8"
Days="25" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Prospective Randomised Control study.Thia study is done on pediatric age group of 2-5 yrs undergoing elective intubations.Aim is to provide oxygenation during apneic period during direct laryngoscopy and delay the fall in saturation thus buying time to attending anesthesiologist during difficult intubations.this study contains 2 groups (test and control)apox group is the test group who will bee provided oxygenation during apneic period through buccal canula.control group that is standard group will not be provided any oxygenation during apneic period.both the groups are observed for fall in saturation after inducing with premedication(ondensetron,midazolam and glycopyrolate),induction(propofol),muscle relaxants(atracurium).time taken for fall in saturation till 95% is noted and compared. |