| CTRI Number |
CTRI/2023/09/057898 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intubation procedure] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two methods of inserting tube in the windpipe (oro-tracheal intubation) in children requiring ventilator support |
|
Scientific Title of Study
|
Comparison Of Videolaryngoscopy And direct laRyngoscopy for pedIatric oro-trAcheal iNTubation in an oncology ICU (COVARIANT): A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4211_Protocol Version 2.1 dated 15.08.23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul Kulkarni |
| Designation |
Professor and Head, Division of Critical Care |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept. of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Dr. E Borges Road, Tata Memorial Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869077526 |
| Fax |
|
| Email |
kaivalyaak@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Kulkarni |
| Designation |
Professor and Head, Division of Critical Care |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept. of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Dr. E Borges Road, Tata Memorial Hospital, Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869077526 |
| Fax |
|
| Email |
kaivalyaak@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohidas Mahale |
| Designation |
DMCCM Post graduate student |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept. of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Dr. E Borges Road, Tata Memorial Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8689869615 |
| Fax |
|
| Email |
dr.rohidasmahale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dept of Anaesthesia, Critical care and Pain, Dr. E Borges Road, Parel, Mumbai |
| 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 Atul Kulkarni |
Tata Memorial Hospital |
Department of Anesthesia Critical care and Pain Second floor, Main Building, Tata Memorial Centre Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA |
9869077526
kaivalyaak@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional (Macintosh) laryngoscope |
Conventional laryngoscope is a curved instrument with light source at one end that helps in visualisation of airway structure, as there is no camera and screen for this instrument, the doctor has to use a certain technique to get direct line to view the airway structures. The procedure duration is around 60-180 seconds. |
| Intervention |
Videolaryngoscope (BPL) |
In VL, the scope incorporates an integrated camera and display monitor, which is used for indirect laryngoscopy to view the airway structures Since the view is obtained “around the corner†the glottis is visualized better by the VL. A lesser quantity of force is required at the base of the tongue during VL. Hence, the chances of local tissue injury and response to stress are reduced. The procedure duration is around 60-180 seconds. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children age between 1 to 12 years admitted in ICU who need oro-tracheal intubation |
|
| ExclusionCriteria |
| Details |
a) Age < 1 year and > 12 years
b) Unstable C-spine
c) Cardiac arrest scenario
d) Children on palliative care intent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt success rate of orotracheal intubation in critically ill children with cancer. |
Immediately post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time required for orotracheal intubation
2. Incidence of mild desaturation (92%)
3. Incidence of sever desaturation (to 85%)
4. Glottic view: POGO score & CL grade
5. Need for External laryngeal manipulation
6. Need for adjuncts to intubation
7. Adverse events such as Oral bleeding, Lip trauma, Dental trauma, Bronchospasm, Cardiac arrythmia, Hypotension, Esophageal intubation, Cuff rupture Sub-cutaneous emphysema, Pneumothorax will be noted
|
Immediately post intubation |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
26/09/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The airway anatomy of the children
is distinctive as compared with adults. The laryngoscopy and intubation in
children are difficult because of restricted opening of the mouth,
comparatively larger tongue and more cephalad larynx; also, the consumption of
oxygen is much higher in children as compared to the adults. Hence, limited
period is available for the intubation in children(1).The presence of
congenital orofacial clefts distort the upper airway anatomy and association
with wider palatal clefts, bilateral cleft lips, major nasal deformity, micrognathia
and receding mandible also increases the intubation difficulty.(2)
Particularly in cancer patient with pneumonia,
radiation exposure, anterior mediastinal mass, orofacial tumors, bleeding
tendency, distorted airway will further reduce the time window and increase
difficulty in tracheal intubation.
In VL, the scope incorporates
an integrated camera and display monitor, which is used for indirect
laryngoscopy to view the airway structures Since the view is obtained “around the
corner†the glottis is visualized better by the VL. A lesser quantity of force
is required at the base of the tongue during VL. Hence, the chances of local
tissue injury and response to stress are reduced. Even though there is limited evidence
that the success of endotracheal intubation (ETI) is increased by VL, VL is now
more.(3)
Since there are no comparative ICU studies
available for pediatric population, we decided to conduct this study. |