| CTRI Number |
CTRI/2021/06/034029 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
04/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two videolaryngoscopes with direct laryngoscope for endotracheal intubation in neonates undergoing surgery under general anaesthesia. |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of two videolaryngoscopes with direct laryngoscope for endotracheal intubation in neonates undergoing surgery under general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Toko Nem |
| Designation |
Post Graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care.Ground floor,main operation theatre building.Safdarjung hospital and Vardhman Mahavir Medical College,New Delhi 110029 Delhi
New Delhi
DELHI
110029
India |
| Phone |
8130802379 |
| Fax |
|
| Email |
tokonem95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Agrawal |
| Designation |
Specialist Grade 1 (Anaesthesia) |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care.Ground floor,main operation theatre building.Safdarjung hospital and Vardhman Mahavir Medical College,New Delhi 110029 Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Toko Nem |
| Designation |
Post Graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care.Ground floor,main operation theatre building.Safdarjung hospital and Vardhman Mahavir Medical College,New Delhi 110029 Delhi
New Delhi
DELHI
110029
India |
| Phone |
8130802379 |
| Fax |
|
| Email |
tokonem95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Safdarjung Hospital and Vardhman Mahavir Medical college,New Delhi.India |
|
|
Primary Sponsor
|
| Name |
Safdarjung Hospital and Vardhman Mahavir Medical collegeNew DelhiIndia |
| Address |
Department of Anaesthesia and Intensive care.Ground floor,main operation theatre building.Safdarjung Hospital and Vardhman Mahavir Medical college,New Delhi.110029.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 |
| Toko Nem |
Safdarjung Hospital and Vardhman Mahavir Medical College,New Delhi.India |
Department of Anaesthesia and Intensive care.Ground floor,main operation theatre building,Safdarjung Hospital and Vardhman Mahavir Medical College,New Delhi.110029.India
New Delhi
DELHI |
8130802379
tokonem95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committeee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P969||Condition originating in the perinatal period, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CMAC MILLER Videolaryngoscope |
Group A patients will be intubated using CMAC Miller videolaryngoscope blade 0.Laryngoscopic view will be graded by the intubating anaesthesiologist using POGO Score and modified Cormack-Lehane grading.The tracheal intubation will be considered successful in presence of bilateral equal chest expansion, bilateral equal breath sounds on chest auscultation and by appearance of square wave capnographic traces on the monitor. |
| Intervention |
McGRATH MAC Videolaryngoscope |
Group B patients will be intubated using McGRATH MAC videolaryngoscope blade 1.Laryngoscopic view will be graded by the intubating anaesthesiologist using POGO Score and modified Cormack-Lehane grading.The tracheal intubation will be considered successful in presence of bilateral equal chest expansion, bilateral equal breath sounds on chest auscultation and by appearance of square wave capnographic traces on the monitor. |
| Comparator Agent |
Miller direct laryngoscope |
Group C patients will be intubated using Miller direct laryngoscope blade 0.Laryngoscopic view will be graded by the intubating anaesthesiologist using POGO Score and modified Cormack-Lehane grading.The tracheal intubation will be considered successful in presence of bilateral equal chest expansion, bilateral equal breath sounds on chest auscultation and by appearance of square wave capnographic traces on the monitor. |
|
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Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All term neonates of either sex undergoing surgical procedures under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1.Patients with anticipated difficult airway,congenital anomalies of head,face and neck,congenital anomalies of lungs and cardiovascular system.
2.Respiratory tract infection,raised intracranial pressure,metabolic and electrolyte imbalance, coagulopathy,hemodynamic instability,liver and kidney diseases. |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total time taken for successful endotracheal intubation |
At the time ofintubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time for achieving best glottic view,
Tube passage time, Total tube
insertion time.
2.POGO score(percentage of glottic
opening)
3.Number of attempts for intubation.
4.Cormack and Lehane grading(modified).
5.Necessity of external laryngeal
manipulation or repositioning of
laryngoscope.
6.Number of attempts for successful
intubation.
|
At the time of intubation. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/06/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endotracheal intubation is considered gold standard for airway management in children. In neonates , a more cephalad larynx, a relatively larger tongue, a large, floppy and omega-shaped epiglottis makes visualization of vocal cords and intubation more difficult with direct laryngoscopy as compared to that in adults. Therefore in this study we will compare efficacy of C-MAC Miller Videolaryngoscope and McGrath MAC videolaryngoscope with Miller direct laryngoscope for endotracheal intubation in neonates undergoing surgical procedures under general anaesthesia in terms of total time taken for successful endotracheal intubation, Time for achieving best glottic view, Tube passage time, Total tube insertion time, POGO score and Number of attempts for intubation, |