CTRI Number |
CTRI/2016/12/007609 [Registered on: 23/12/2016] Trial Registered Prospectively |
Last Modified On: |
31/05/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
comparison of two types of laryngoscope blades for intubation under anesthesia in infants |
Scientific Title of Study
|
Comparative evaluation of the TruView PCD and C-MAC infant video laryngoscopes for tracheal intubation in infants with normal airways: A prospective randomized study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Anju Gupta |
Designation |
Assistant Professor |
Affiliation |
Chacha Nehru Bal Chikitsalya |
Address |
Departemnt of Anesthesiology, Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi
East DELHI 110031 India |
Phone |
9643308220 |
Fax |
|
Email |
dranjugupta2009@rediffmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anju Gupta |
Designation |
Assistant Professor |
Affiliation |
Chacha Nehru Bal Chikitsalya |
Address |
Departemnt of Anesthesiology, Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi
DELHI 110031 India |
Phone |
9643308220 |
Fax |
|
Email |
dranjugupta2009@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Anju Gupta |
Designation |
Assistant Professor |
Affiliation |
Chacha Nehru Bal Chikitsalya |
Address |
Departemnt of Anesthesiology, Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi
DELHI 110031 India |
Phone |
9643308220 |
Fax |
|
Email |
dranjugupta2009@rediffmail.com |
|
Source of Monetary or Material Support
|
Chacha Nehru Bal Chikitsalya |
|
Primary Sponsor
|
Name |
Chacha Nehru Bal Chikitsalya |
Address |
Geeta Colony, New Delhi |
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 |
Dr Anju Gupta |
Chacha Nehru Bal Chikitsalya |
OT block second floor, Department of Anesthesia
Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi-110031 East DELHI |
9643308220
dranjugupta2009@rediffmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
MAMC and GB Pant Ethics committe |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
60 ASA Grade – I/II infants (less than 1 year) of either sex admitted for elective surgery requiring general anesthesia and endotracheal intubation, (1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group CM |
intubated with the aid of CMAC laryngoscope (size 0, 1) |
Comparator Agent |
Group TR |
intubated by the Truview PCD (size 0, 1) |
|
Inclusion Criteria
|
Age From |
0.00 Day(s) |
Age To |
1.00 Year(s) |
Gender |
Both |
Details |
ASA Grade – I/II infants (less than 1 year) of either sex admitted for elective surgery requiring general anesthesia and endotracheal intubation |
|
ExclusionCriteria |
Details |
Patients with an ASA physical status greater than Grade II, features suggestive of increased intracranial pressure, increased risk for pulmonary aspiration of gastric contents, known coagulopathy and any pathology of the head and neck will be excluded. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the time required for intubation with CMAC videolaryngosocpe and Truview PCD videolaryngoscope for intubation in infants |
time to intubation will be recorded once |
|
Secondary Outcome
|
Outcome |
TimePoints |
first attempt and overall success rate, number of attempts for intubation, the glottis views using Cormack Lehane grading system
|
during intubation period |
|
Target Sample Size
Modification(s)
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
23/12/2016 |
Date of Study Completion (India) |
28/04/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Gupta A, Kamal G, Gupta A, Sehgal N, Bhatla S, Kumar R. Comparative evaluation of CMAC and Truview picture capture device for endotracheal intubation in neonates and infants undergoing elective surgeries: A prospective randomized control trial. Paediatr Anaesth. 2018;28(12):1148â€1153. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Airway
management in infants remains a challenge to anesthesiologist due to various morphological features. Videolaryngoscope
are increasingly being used in this patient population.
Truview PCD was the earliest videolaryngoscope introduced for pediatric
patients. It has demonstrated superiority regarding airway management over
conventional direct laryngoscopy. Novel C-MAC infant blade (Karl Storz GmbH & Co. KG,
Tuttlingen, Germany) has a camera providing an 80° angle of view and a light
source are recessed from the tip of the blade. The electronic unit sits in a
handle attached to the laryngoscope blade and is connected by a wire to a
portable TFT video monitor. The system allows for the Macintosh laryngoscope
blade to be used for direct and indirect laryngoscopy. C-MAC infant blade has not been prospectively
compared to Truview videolaryngosocpe in the past. After
institutional research committee’s approval this prospective, randomized, study
will be conducted in 60 ASA Grade – I/II infants ( 0-12months) of
either sex admitted for elective surgery under general anesthesia who will be divided into two groups of 60 each:
Group
CM [intubated with the aid of
CMAC laryngoscope (size 0, 1)]
Group
TR (intubated by the Truview PCD (size 0, 1)
After a thorough preanesthetic checkup,
adequate fasting as per the ASA guidelines, and written informed
parents/guardian consent, the infants will be shifted to the operating room and
routine monitors will be applied. Inhalational/ intravenous induction will be
achieved as deemed appropriate. Neuromuscular blockade will facilitated by
atracurium besylate bromide 0.5 mg/kg and trachea intubated after 180 seconds. Patients allocated to Group TR will be intubated with
the aid of the Truview PCD and appropriate size stylet provided with Truview.
In Group CM, the CMAC videolaryngosocpe with an appropriate size stylet will be
used to intubate. All intubations will be performed by the anesthesiologist
with more than 10 year experience with intubation in pediatric patients and a
previous experience of at least 20 intubations with the Truview PCD and the
C-MAC blade. The time to intubation will be
measured by an independent observer using stop watch. The number of attempts
was defined as withdrawing the tube to the angle of the mouth and reintroducing
it. Single intubation attempt will be limited to <20seconds. Any fall in
oxygen saturation to < 95% on the pulse oximeter will be noted and the lungs
will be ventilated with 100% oxygen. If more than three attempts or if > 60
seconds were required after combined attempts to secure an endotracheal tube,
it was considered a failed intubation. Primary endpoint in our study will be
the total time required for successful intubation. The ease
of intubation will be graded by the intubating anesthetist on a numerical
rating scale. The
data thus collected will be expressed as a number or mean ± standard deviation.
Appropriate statistical tests will be applied for analysis. |