CTRI Number |
CTRI/2019/01/016886 [Registered on: 03/01/2019] Trial Registered Prospectively |
Last Modified On: |
02/01/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To compare tracheal intubation with two video laryngoscopes after anesthesia induction in infants |
Scientific Title of Study
|
COMPARATIVE EFFICACY OF CMAC MILLER VIDEOLARYNGOSCOPE Versus McGRATH MAC VIDEOLARYNGOSCOPE IN INFANTS UNDERGOING SURGICAL PROCEDURES |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Pooja Singh |
Designation |
Post graduate student |
Affiliation |
VMMC and Safdarjung Hospital |
Address |
Department of Anesthesiology and Intensive care, VMMC and Safdarjung Hospital
South DELHI 110029 India |
Phone |
|
Fax |
|
Email |
shaku.nip5588@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Anju Gupta |
Designation |
Assistant Professor |
Affiliation |
VMMC and Safdarjung Hospital |
Address |
Department of Anesthesiology and Intensive care, VMMC and Safdarjung Hospital
South DELHI 110029 India |
Phone |
9911573371 |
Fax |
|
Email |
dranjugupta2009@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
K K Girdhar |
Designation |
Consultant and Professor |
Affiliation |
VMMC and Safdarjung Hospital |
Address |
Department of Anesthesiology and Intensive care, VMMC and Safdarjung Hospital
South DELHI 110029 India |
Phone |
|
Fax |
|
Email |
drkkgirdhar@gmail.com |
|
Source of Monetary or Material Support
|
Departmental of Anesthesia and Intensive care, VMMC and Safdarjung Hospital, New Delhi |
|
Primary Sponsor
|
Name |
Department of Anesthesiology and Intensive Care |
Address |
VMMC and Safdarjung Hospital |
Type of Sponsor |
Research institution and hospital |
|
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 |
Anju Gupta |
VMMC and Safdarjung hospital |
OT Complex, second floor, New Emergency Block, Department of Anesthesiology and Intensive Care South DELHI |
9911573371
dranjugupta2009@rediffmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committe, VMMC and Safdarjung Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
CMAC Group |
Intubation with CMac Videolaryngosocpe (Miller Blade) |
Intervention |
McGrath Group |
Intubation with McGrath Videolaryngosocpe |
|
Inclusion Criteria
|
Age From |
0.00 Day(s) |
Age To |
12.00 Month(s) |
Gender |
Both |
Details |
American Society of Anaesthesiologists (ASA) grade I- III. |
|
ExclusionCriteria |
Details |
Anticipated difficult airway or any such history
Congenital anomalies of head and neck
History of birth asphyxia
Coagulation defect
Any child with increased risk of aspiration |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Total intubation time |
after intubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
Time to glottic view, tube insertion time, ETCO2 at the end of intubation, lowest SpO2 saturation reading during the intubation, POGO score and Modified Cormack-Lehane score, intubation difficulty scores & need for optimizing manoeuvres [OELM/ head extension], successful intubation at first attempt and total number of attempts, hemodynamic parameters, complications desaturation (SPO2 95%), trauma (lip, gum, airway), mucosal bleed or esophageal intubation.
|
one time |
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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)
|
07/01/2019 |
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
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Airway
management is integral part
of general anaesthesia. Videolaryngoscopy (VL) is a new technique that has
the potential to facilitate endotracheal intubation and decrease adverse
consequences. In adult population the advantages of VL over direct
laryngoscopy (DL) have already been proven in several studies conducted in patients
with normal and difficult airways and critically ill patient. In
comparison to adults, intubation in infant and neonates is more challenging due
to various anatomical and physiological factors. Pediatric tracheal intubations (TI) may require
multiple attempts, especially in neonates and infants and those with a history
of difficult airway and craniofacial anomalies. But, each additional attempt is
associated with increased chances of desaturation and airway morbidity.
VL
facilitates tracheal intubation during simulated/ clinically difficult
intubation in adults, but it is not clear whether these findings translate to
children. Comprehensive clinical studies about the efficacy of paediatric VL for routine practice in difficult airways in children are inadequate and poorly documented. Well-designed,
adequately powered randomized controlled studies are necessary to address
efficacy and safety of VL for endotracheal intubation in neonates.
CMAC
VL has compared favorably to the conventional DL for intubation in infants and
children. Recently,
McGrath MAC blade size 1 VL has been launched which is similar to conventional
Macintosh blade. There is paucity of studies comparing CMAC
Miller blade VL with McGrath MAC blade VL in respect to their clinical
efficacy in infants. So,
we aim to establish whether the novel McGrath MAC videolaryngoscope provides
equivalent performance as compared to CMAC Miller videolaryngoscope with
respect to time to intubation in infants. We will recruit a total of 140 neonates and infants as per our inclusion and exclusion criteria as mentioned above. After standard General anesthesia they will be intubated as per their group allocation. the observations will be recorded as mentioned above. |