| CTRI Number |
CTRI/2022/07/044310 [Registered on: 25/07/2022] Trial Registered Prospectively |
| Last Modified On: |
02/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Reason of more then two attempts of laryngoscopy in children age 0-12years |
|
Scientific Title of Study
|
Incidence and factors responsible for multiple attempts at laryngoscopy in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aarti Agarwal |
| Designation |
Associate professor |
| Affiliation |
SGPGIMS |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SGPGIMS
LUCKNOW
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8765974039 |
| Fax |
|
| Email |
aarti_agarwal000@yahoo.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aarti Agarwal |
| Designation |
Additional professor |
| Affiliation |
SGPGIMS |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SGPGIMS
LUCKNOW
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8765974039 |
| Fax |
|
| Email |
aarti_agarwal000@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangh Ratna Gautam |
| Designation |
Junior Resident |
| Affiliation |
SGPGIMS |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
SGPGIMS,LUCKNOW
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
7991644204 |
| Fax |
|
| Email |
sanghratna19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, UP |
|
|
Primary Sponsor
|
| Name |
Dr Aarti Agarwal |
| Address |
Associate Professor,Department of Anesthesiology, SGPGIMS, Lucknow |
| 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 Aarti Agarwal |
SGPGIMS,Lucknow |
Peadiatric OT,First Floor,PMSSY BLOCK. Main OT Complex, Main Neuro OT SGPGIMS , LUCKNOW
Lucknow
UTTAR PRADESH |
8765974039
aarti_agarwal0000@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee ,sgpgi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
.All patient of age 0-12 years,
.Requiring GA with ET intubation for elective
surgical procedure
.ASA I and ASA II |
|
| ExclusionCriteria |
| Details |
ASA IV patient
Emergency cases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the incidence of Multiple (More than 1)attempts of Laryngoscopy before endotracheal intubation in children undergoing elective surgery requiring general anaesthesia
|
One time point that is after induction of general anaesthesia but before endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify factors responsible for multiple attempts of laryngoscopy |
Single time point i.e. after induction of general anaesthesia but before endotracheal intubation |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="538" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Paediatric airway management has always posed a greater challenge, for anesthesiologists, in contrast to adults. Although most children with difficult airways are recognised before induction of anesthesia but still chances of airway related adverse events is more in younger population. Reasons for this lies in the fact that pediatric respiratory physiology is different from that of adult. They have low physiologic reserve, Oxygen consumption is higher, have lower functional residual capacity and their airway is more reactive. A small amount of narrowing (due to oedema, inflammation, etc.,) in the already small pediatric airway have severe consequences on respiratory function. Increase in number of laryngoscopy attempts cause increased airway manipulation, and longer discontinuation of oxygenation, leading to laryngospasm, desaturation, bradycardia, Airway oedema, airway trauma, aspiration, hypoxemia, hypotension, dysrhythmia and cardiac arrest. Thoughtful attention to recognition of factors which may contribute to increase in laryngoscopy attempts may help in maximizing the chance for first attempt success. The incidence of multiple attempts and various factors responsible for it are not properly defined in patient population presenting to our institute. Identification of various factors will help to reduce the risk of adverse events associated with multiple laryngoscopy attempts. The number of laryngoscopy attempts matter!! |