| CTRI Number |
CTRI/2024/06/068567 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| 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
|
Comparison of two different patient positions for endotracheal intubation through a supraglottic airway device in pediatric surgeries |
|
Scientific Title of Study
|
Comparison of supine versus lateral decubitus position for endotracheal intubation through BlockBuster laryngeal mask airway in pediatric population- A randomised interventional study in SMS Medical College , Jaipur |
| 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 Pratibha Rathore |
| Designation |
Associate Professor |
| Affiliation |
Sawai Maan Singh Medical College and Attached Hospital |
| Address |
Department of Anaesthesia, Sawai Maan Singh Medical College and Attached Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414446473 |
| Fax |
|
| Email |
pratibha.rathore3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha Rathore |
| Designation |
Associate Professor |
| Affiliation |
Sawai Maan Singh Medical College and Attached Hospital |
| Address |
Department of Anaesthesia, Sawai Maan Singh Medical College and Attached Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414446473 |
| Fax |
|
| Email |
pratibha.rathore3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshita Rai |
| Designation |
Junior Resident |
| Affiliation |
Sawai Maan Singh Medical College and Attached Hospital |
| Address |
Department of Anaesthesia, Sawai Maan Singh Medical College and Attached Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9740107554 |
| Fax |
|
| Email |
harshihenu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Sawai Maan Singh Medical College And Attached Hospitals,Jaipur 302004 , Rajasthan , India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia Sawai Maan Singh Medical College and Attached Hospital Jaipur Rajasthan |
| Address |
JLN Marg ,Adarsh Nagar , Jaipur 302004 , Rajasthan , India |
| Type of Sponsor |
Government medical college |
|
|
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 Pratibha Rathore |
Sawai Maan Singh Medical College and Attached Hospitals |
Operation Theatres , First floor, department of Anaesthesia , J K Lon hospital , JLN Marg,Adarsh Nagar , Jaipur 302004 , Rajasthan ,India
Jaipur
RAJASTHAN |
9414446473
pratibha.rathore3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee,SMS Medical College And Attached Hospitals, Jaipur |
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 |
Patients airway will be secured with BlockBuster in lateral position |
Comparison of the success rate of endotracheal intubation through blockbuster laryngeal mask airway in supine versus lateral position Total duration of device till successful intubation |
| Intervention |
Patients airway will be secured with BlockBuster in supine position |
Comparison of the success rate of endotracheal intubation through blockbuster laryngeal mask airway in supine versus lateral position Total duration of device till successful intubation |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Consent given by guardian or caretaker of patients for participation in study
Undergoing elective paediatric surgery requiring endotracheal intubation
ASA grade 1 & 2 |
|
| ExclusionCriteria |
| Details |
Patient should not be part of other study
Children with craniofacial deformities and cervical spine disease
Children with dental abnormalities or surgeries of oral cavity or if prone to aspiration
Respiratory and pharyngeal pathology |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total number of attempts and total time taken for successful endotracheal intubation through BlockBuster laryngeal mask airway in both study groups i.e. supine versus lateral |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in fibreoptic grade of view ( brimacombe score) in both the study groups |
After insertion of device |
| To determine the difference in the mean oropharyngeal leak pressure |
After insertion of device |
| To compare the intraoperative hemodynamic changes- Heart rate,SBP,DBP & MAP between both groups |
Baseline
After induction of anaesthesia immediately after intubation
1 min after intubation
3 mins after intubation
5 mins after intubation
7 mins after intubation
10 mins after intubation |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
17/06/2024 |
| 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="0"
Months="2"
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
|
Securing airway is a vital responsibility of anaesthesiologists. Recently, supraglottic airway devices with a conduit for blind tracheal intubation are gaining popularity as a bridge connecting ventilation and intubation in all genre of patients. A second generation laryngeal mask airway, BlockBuster is advantageous in providing ventilation and increased green channel for intubation. As children are less tolerant of apnoea ,which results in inadequate ventilation leading to brain damage , thus emphasises the use of supraglottic airway device that are specifically designed to serve as a conduit for intubation when a pediatric fibrescope is unavailable or when secretions and bleeding hinder its use. Purpose of this study is to find out which position out of supine and lateral decubitus is more efficacious for endotracheal intubation through BlockBuster laryngeal mask airway in children. |