| CTRI Number |
CTRI/2024/05/067270 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two kind of blade of video laryngoscope for endotracheal intubation |
|
Scientific Title of Study
|
Comparison of Channeled versus non-Channeled blade of video laryngoscope for emergency endotracheal intubation: A randomized clinical 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 Sangeeta Sahoo |
| Designation |
Additional professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room no.-342
Academic block
AIIMS Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9556547655 |
| Fax |
|
| Email |
drsangeeta.asth@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sangeeta Sahoo |
| Designation |
Additional professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room no.-342
Academic block
AIIMS Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9556547655 |
| Fax |
|
| Email |
drsangeeta.asth@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shiny |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Trauma and Emergency
AIIMS Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9959100118 |
| Fax |
|
| Email |
shinyjaladi1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar
Orissa,India
PIN-751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
AIIMS Bhubaneswar,Orissa
PIN-751019 |
| 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 SHINY JALADI |
All India Institute of Medical Sciences, Bhubaneswar |
Emergency Room
Department of Trauma and Emergency Khordha ORISSA |
9959100118
shinyjaladi1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (Registration No. ECR/534/Inst/OD/2014/RR-20 All India Institute of Medical Sciences Bhubaneswar |
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 |
Channel blade of video laryngoscope; |
For group NCB, intubations Will be performed using Non-Chanell blade of video Laryngoscope. Anaesthesia induction before intubation will be carried with etomidate 0.2–0.3 mg/kg preceded by three minutes of pre oxygenation with 100% oxygen. Rapid sequence intubation (RSI) will be done by 30 seconds after succinylcholine with a dose of 1.5 mg/kg. This process will be commenced by post-graduate emergency medicine student with at least six months of experience in various intubation. The definition of intubation attempt will be defined if any insertion of laryngoscope enters beyond the level of teeth, disregarding of successful outcome. A successful try of intubation termed with equal chest rise on both side and bilateral chest auscultation with stethoscope. The time measured from the point of insertion of laryngoscope blade to mouth till the confirmation of correct placement of the tube into the vocal cord will be regarded as time needed to perform tracheal intubation. Hypotension will be termed as when systolic blood pressure lesser than 100 mmHg, and brady cardia when heart rate lesser than 60 beats per minute Hypoxia will be defined when saturation of oxygen showing in pulse manometry or in Monitor lower than 93% at any point starting from pre oxygenation time till 15-min post intubation. |
| Comparator Agent |
Non-Channel blade of video laryngoscope; |
Patients will be divided on random basis into two groups by using computer generated random codes. For group NCB, intubations Will be performed using Non-Channel blade of video Laryngoscope. Anaesthesia induction before intubation will be carried with etomidate 0.2–0.3 mg/kg preceded by three minutes of pre oxygenation with 100% oxygen. Rapid sequence intubation (RSI) will be done by 30 seconds after succinylcholine with a dose of 1.5 mg/kg. This process will be commenced by post-graduate emergency medicine student with at least six months of experience in various intubation. The definition of intubation attempt will be defined if any insertion of laryngoscope enters beyond the level of teeth, disregarding of successful outcome. A successful try of intubation termed with equal chest rise on both side and bilateral chest auscultation with stethoscope. The time measured from the point of insertion of laryngoscope blade to mouth till the confirmation of correct placement of the tube into the vocal cord will be regarded as time needed to perform tracheal intubation. Hypotension will be termed as when systolic blood pressure lesser than 100 mmHg, and brady cardia when heart rate lesser than 60 beats per minute Hypoxia will be defined when saturation of oxygen showing in pulse manometry or in Monitor lower than 93% at any point starting from pre oxygenation time till 15-min post intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Critically ill patients requiring emergency intubation on arrival. |
|
| ExclusionCriteria |
| Details |
1.cardiac arrest intubations
2.hyperkalaemia
3.burn and crush injuries
4.Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be time to endotracheal intubation. |
At baseline, 1 minute,2minutes,5 minutes, 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include, success rate of intubation in first attempt and incidence of esophageal intubation and airway related complications like blood in the oral cavity, dental trauma. |
At baseline, 1 minute,2minutes,5 minutes, 10 minutes |
|
|
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)
|
25/06/2024 |
| 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="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
|
Endotracheal Intubation is a life-saving procedure performed in emergency departments (EDs) across the globe. Under some circumstances, it has been found that; it seems pretty much impossible to align the axes, making direct visualization of the laryngeal inlet difficult or impossible with direct laryngoscopy and there by proving it to be a futile one. But the most detrimental part of this we lose a patient due to unnecessary delay in intubation. So, these cases present as a particularly challenging situation for emergency physicians and there what the video laryngoscopes does come into action. The faster intubation time escalating the ease of intubation in video laryngoscopes. The first pass success rate of video intubation rely on cumulative factors i.e blade size, blade type, design, structural configurations, angulation of blade (obtuse /acute. It is generally accepted that using a video laryngoscope is associated with an improved visualization of the glottis. However, correctly placing the endotracheal tube might be challenging. Channelled video laryngoscopy blades have an endotracheal tube already pre-loaded, allowing to advance the tube once the glottis is visualized. We hypothesized that use of a channel blade with pre-loaded endotracheal tube results in a faster intubation, compared to a curved Macintosh blade video laryngoscope. To our knowledge, no randomized controlled study has examined the relative performance of Chanell blade with that non-Chanell blade of video laryngoscope in emergency set up for tracheal intubation. The aim of the study was to compare the emergency tracheal intubation performances of the video laryngoscope non channelled blade with that Chanell blade in the emergency department. | |