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CTRI Number  CTRI/2025/04/084069 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 03/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Comparing Two Laryngoscopes for Safer Intubation in Young Children  
Scientific Title of Study   An observational Study for comparision between oxiport laryngoscope versus conventional laryngoscope for hemodynamic response during intubation in paediatric age group up to 3 years undergoing general anaesthesia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRKARNATI ESHWAR 
Designation  Resident doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General ot Complex,2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia,Vadodara,GUJARAT,391760 India

Vadodara
GUJARAT
391760
India 
Phone  9963404402  
Fax    
Email  Eshwar.eshwar.karnati6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jatin Patel 
Designation  Professor 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General ot Complex,2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia,Vadodara,GUJARAT,391760

Vadodara
GUJARAT
391760
India 
Phone  9879368363  
Fax    
Email  Dr_jatinpatel@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Jatin Patel 
Designation  Professor 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General ot Complex,2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia,Vadodara,GUJARAT,391760


GUJARAT
391760
India 
Phone  9879368363  
Fax    
Email  Dr_jatinpatel@yahoo.co.in  
 
Source of Monetary or Material Support  
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode-391760 
 
Primary Sponsor  
Name  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Cen 
Address  Wagodhia,Pipariya,Vadodara, Gujarat,India Pincode-391760 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jatin Patel  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre  2nd Floor,General ot complex,Anesthesia Department,Dhiraj hospital,Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre ,Sumandeep vidyapeeth Wagodhia,Pipariya, Vadodara ,GUJARAT 391760 India.
Vadodara
GUJARAT 		 9879368363

Dr_jatinpatel@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  3.00 Year(s)
Gender  Both 
Details  Patients parents or gaurdians willing to sign the written informed consent.
Patients of either gender aged between 6 months to 3 years.
Patients undergoing elective surgical procedures under general anaesthesia.
Patients belonging to ASA I and II.
No known history of allergy and hypersensitivity to study drug. 
 
ExclusionCriteria 
Details  Patients with history of prior hypoxic, patients with known upper respiratory tract infection or lower
respiratory tract infection.
Patients with known allergy, sensitivity or any other form of reaction to study drug.
Patients with poor cardiovascular and respiratory reserve and a known case of congnital heart disease
Patients with anaemia Hb less than 12 gm percentage.
Patients with ASA III or more.
Patient and or his or her legally acceptable representative not willing to provide their voluntary written informed consent for participation in the study.
Patients with oral pathologies like cleft lip and palate
Patients undergoing nasal intubation 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
We will get to know and compare effects and efficacy of desaturation with two blades  We will get to know and compare effects and efficacy of desaturation and hemodynamic with two blades after Intubation
0 min
1 min
2 min
3 min
5 min
10 min
15 min
30 min
45 min
60 min
90 min
120 min 
 
Secondary Outcome  
Outcome  TimePoints 
hemodynamic changes like SPO2,SBP,DBP,PR  0min
1min
2min
3min
5min
10min
15min
30min
45min
60min
75min
90min
120min  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   14/04/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  dr_jatinpatel@yahoo.co.in

  6. For how long will this data be available start date provided 24-05-2025 and end date provided 24-05-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Observational Study for comparision between oxiport laryngoscope versus conventional laryngoscope for hemodynamic response during intubation in paediatric age group up to 3 years undergoing general anaesthesia


AIM 

To compare hemodynamic response during intubation between oxiport laryngoscope and

conventional laryngoscope in pediatric age group under going general anaesthesia.


OBJECTIVES 

1. To compare incidence of hypoxia during intubation

2. To compare severity of hypoxia during intubation

3. To compare no of intubation attempts

3. Comparison of hemodynamic response


Site of Study  Department of Anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara, Gujarat.

Study Design  Prospective Observational comparative Study

Study Duration  The study will be initiated after obtaining the permission from institutional ethics committee till the achievement of the sample size or by 18 months whichever is earlier.

 
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