| CTRI Number |
CTRI/2021/02/031427 [Registered on: 22/02/2021] Trial Registered Prospectively |
| Last Modified On: |
28/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
STUDY COMPARING PAEDIATRIC VIDEO LARYNGOSCOPE WITH DIRECT MACINTOSH LARYNGOSCOPE FOR ENDOTRACHEAL INTUBATION |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF PAEDIATRIC C-MAC VIDEO LARYNGOSCOPE AND MACINTOSH DIRECT LARYNGOSCOPE FOR ENDOTRACHEAL INTUBATION IN PAEDIATRIC PATIENTS POSTED FOR ELECTIVE 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 |
NANDI VINAYAKA B |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
JSS MEDICAL COLLEGE |
| Address |
DOOR NO. 225, 16TH MAIN, 9TH CROSS, KAMAKSHI HOSPITAL ROAD,
SARASWATHIPURAM, MYSURU
JSS MEDICAL COLLEGE AND HOSPITAL,
MG ROAD,
MYSURU
Mysore
KARNATAKA
570009
India |
| Phone |
9880626679 |
| Fax |
|
| Email |
NANDIVINAYAKAB@YAHOO.IN |
|
Details of Contact Person
Scientific Query
|
| Name |
MANJULA B P |
| Designation |
Professor |
| Affiliation |
JSS MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology,
JSS MEDICAL COLLEGE AND HOSPITAL,
MYSURU
JSS MEDICAL COLLEGE AND HOSPITAL,
MG ROAD,
MYSURU
Mysore
KARNATAKA
570009
India |
| Phone |
9880626679 |
| Fax |
|
| Email |
Bpmanjula5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NANDI VINAYAKA B |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
JSS MEDICAL COLLEGE |
| Address |
DOOR NO. 225, 16TH MAIN, 9TH CROSS, KAMAKSHI HOSPITAL ROAD,
SARASWATHIPURAM, MYSURU
JSS MEDICAL COLLEGE AND HOSPITAL,
MG ROAD,
MYSURU
KARNATAKA
570009
India |
| Phone |
9880626679 |
| Fax |
|
| Email |
NANDIVINAYAKAB@YAHOO.IN |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
JSS MEDICAL COLLEGE,
S.S NAGAR
MYSURU |
| Type of Sponsor |
Private 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 NANDI VINAYAKA B |
JSS HOSPITAL |
Department of anaesthesiology, 3rd floor, JSS HOSPITAL,
MG ROAD
MYSURU
Mysore
KARNATAKA |
9880626679
NANDIVINAYAKAB@YAHOO.IN |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS MEDICAL COLLEGE |
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 |
DIRECT LARYNGOSCOPY AND INTUBATION |
ENDOTRACHEAL INTUBATION IN PEDIATRIC PATIENTS UNDER DIRECT LARYNGOSCOPY |
| Comparator Agent |
NIL |
NIL |
| Intervention |
VIDEOLARYNGOSCOPY AND INTUBATION |
ENDOTRACHEAL INTUBATION IN PEDIATRIC PATIENTS UNDER C-MAC VIDEOLARYNGOSCOPY |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA 1 AND 2 CLASSIFICATION
2. WEIGHT 10-20 KGS |
|
| ExclusionCriteria |
| Details |
1. PARENTAL REFUSAL FOR THE PROCEDURE
2. OROPHARYNGEAL ANOMALIES
3. ANY SIGNS OF RESPIRATORY TRACT INFECTION
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GLOTTIC VIEW BY MODIFIED CORMACK-LEHANE GRADING |
AT TIME OF INTUBATION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NUMBER OF ATTEMPTS TAKEN FOR INTUBATION |
AT TIME OF INTUBATION |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/07/2021 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway
management is a fundamental procedural skill for practice of general
anaesthesia. In most cases, orotracheal intubation is done by direct
laryngoscopy, in which a conventional laryngoscope is used to establish a
direct line of sight from the laryngoscopist through the patient’s mouth to the
glottic opening.[1]
In
recent years video laryngoscopy has played an important role in the management
of patients with unanticipated difficult or failed endotracheal intubation.
Video laryngoscopy is a term used for techniques applied to intubation in
which the glottis opening is visualized indirectly over the monitor screen,
allowing the laryngoscopist to place an endotracheal tube without seeing the
larynx directly. Different videolaryngoscopes are available with combined
direct/indirect glottic view (C-MAC, Karl Storz, Tuttlingen, Germany) as well
as obligate indirect glottic view (e.g., GlideScope, McGrath video
laryngoscope), depending on the blade.[2]
Routine
airway management and a detailed handling of the expected and unexpected airway
difficulty are the specific concerns for anaesthesiologists. A combined
direct/indirect laryngoscopy may hence be preferred.[3]
The
challenges faced in the management of paediatric airway are based on anatomical
differences from adults. The prediction of difficult airway is not feasible in
child because measurement of mentohyoid, thyromental and inter-incisior lengths
are not validated.[4]
In
comparison with adults, physiological variation like higher oxygen consumption
leads to early desaturation during tracheal intubation, thus highlighting the
importance of time taken for intubation in paediatric patients. Failure to
secure the airway remains the leading cause for morbidity and mortality in the
operative and ICU emergency setting.
Compared
to direct laryngoscopy, video laryngoscopes are preferred lately as they
provide a better glottic view with minimum manipulation of neck, airway and
larynx. In spite of the better view the maneuvering of the endotracheal tube is difficult because it
requires higher level of hand eye co-ordination.[4]
This
study intends to compare the Paediatric C-MAC Video laryngoscopy with
conventional Macintosh laryngoscopy in Indian paediatric population. |