CTRI Number |
CTRI/2022/10/046854 [Registered on: 27/10/2022] Trial Registered Prospectively |
Last Modified On: |
26/10/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Medical Device Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of two devices used during general anesthesia |
Scientific Title of Study
|
Comparison of intubation characteristics of King Vision video laryngoscope vs C-Mac video laryngoscope for nasotracheal intubation- A randomised controlled study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Jerome Kumar R |
Designation |
First year postgraduate student |
Affiliation |
St.Johns Medical college and hospital, Bengaluru-560034. |
Address |
Dept. of Anesthesiology,
Second floor OT complex,
St.Johns Medical college and hospital,
Bengaluru-560034.
Bangalore KARNATAKA 560034 India |
Phone |
7402055868 |
Fax |
|
Email |
jeromekumar.r95@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Surbhi Gupta |
Designation |
Professor |
Affiliation |
St.Johns Medical college and hospital, Bengaluru-560034. |
Address |
Dept. of Anesthesiology,
Second floor OT complex,
St.Johns Medical college and hospital,
Bengaluru-560034.
Bangalore KARNATAKA 560034 India |
Phone |
9880109361 |
Fax |
|
Email |
surbhi_pg@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Surbhi Gupta |
Designation |
Professor |
Affiliation |
St.Johns Medical college and hospital, Bengaluru-560034. |
Address |
Dept. of Anesthesiology,
Second floor OT complex,
St.Johns Medical college and hospital,
Bengaluru-560034.
Koppal KARNATAKA 560034 India |
Phone |
9880109361 |
Fax |
|
Email |
surbhi_pg@yahoo.com |
|
Source of Monetary or Material Support
|
Dept. of anesthesiology,St.Johns medical college and hospital,Bengaluru. |
|
Primary Sponsor
|
Name |
Jerome Kumar R |
Address |
Dept. of Anesthesiology,
Second floor OT complex,
St.Johns Medical college and hospital,
Bengaluru-560034. |
Type of Sponsor |
Other [Self] |
|
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 |
Jerome Kumar R |
St Johns Medical college and hospital |
Second floor OT complex, Department of Anesthesiology, St Johns medical college and hospital,
Sarjapur road,
Bengaluru-560034 Bangalore KARNATAKA |
7402055868
jeromekumar.r95@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics committee, St.Johns medical college, Bengaluru |
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 |
C-Mac videolaryngoscope |
Time for nasotracheal intubation |
Comparator Agent |
Non channeled King vision videolaryngoscope |
Time for nasotracheal intubation |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
59.00 Year(s) |
Gender |
Both |
Details |
American Society of Anesthesiologists physical status(ASA) grade 1 and 2 patients scheduled for elective or emergency maxillofacial or oral cavity surgeries requiring nasotracheal intubation. |
|
ExclusionCriteria |
Details |
1.Anticipated difficult endotracheal intubation (Mallampati score IV and thyromental distance of ≤6.0cm)
2.Coagulopathy
3.A history of nasal deformity, obstructive sleep apnoea, recurrent epistaxis, nasopharyngeal abnormality or surgery
4.Severe obesity (body mass index [BMI] ≥35kg/m2)
5.Cervical spine instability/pathology or cervical myelopathy
6.Pregnancy
7.Neck mass
8.Gastro oesophageal reflux disease
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Time taken for nasotracheal intubation |
T1–Time taken to pass endotracheal tube from nose into oropharynx
T2–Time taken to pass endotracheal tube from oropharynx into glottic inlet
T3–Time taken to pass endotracheal tube from glottic inlet to observation of first capnographic trace |
|
Secondary Outcome
|
Outcome |
TimePoints |
Glottic view as percentage of glottis opening (POGO) score |
At the time of laryngoscopy |
Modified nasal intubation-difficulty scale (NIDS) rating |
At the time of laryngoscopy |
Complications in the two groups |
At the time of glottic visualization,
1 and 3 minutes after intubation |
|
Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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)
|
01/11/2022 |
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
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
COMPARISON OF INTUBATION CHARACTERISTICS
OF KING VISION VIDEO LARYNGOSCOPE VS C-MAC VIDEOLARYNGOSCOPE FOR NASOTRACHEAL
INTUBATION – A RANDOMISED CONTROLLED STUDY Nasotracheal
intubation is essential to provide surgical access in patients who are
undergoing oral and maxillofacial surgeries. Nasotracheal intubation is more
challenging than orotracheal intubation due to the difficulty in advancing the
tip of the endotracheal tube into the trachea.Video laryngoscopes aid in
visualisation of the vocal cords without the need to align the oral, pharyngeal, and tracheal axes hence facilitating intubation. This study will be done to
compare C-MAC D-blade video laryngoscope to non-channelled King Vision video
laryngoscope for nasotracheal intubation. This study will include 86 ASA -1 and ASA-2 patients aged
between 18 to 59 years undergoing maxillofacial or oral cavity surgery
requiring nasotracheal intubation. Patients will be divided into 2 groups (43 each) randomly via computer generated sequence. A detailed
preanesthetic evaluation and all the relevant investigations will be done. On arrival in OT,
standard ASA monitors will be attached and all patients will be
premedicated using 0.02 mg/kg midazolam, 0.2mg glycopyrrolate, 4mg ondansetron and
2mcg/kg fentanyl intravenously. All
the patients will be preoxygenated with 100% oxygen for 3 minutes. Standard induction will be
with Inj. Propofol 1.5-2mg/kg intravenously and Inj. Atracurium 0.5 mg/kg
intravenously for muscle relaxation. Isoflurane will be used as the
inhalational agent. Nasotracheal intubation will be performed with
appropriately sized RAE(Ring-Adair-Elwin) endotracheal tube by an experienced anaesthesiologist.The primary outcome variable will be total intubation time calculated from the beginning of introduction of
the RAE endotracheal tube in the nostril till the appearance of the first end‑tidal
carbon dioxide waveform(capnography). This will
include time required for insertion of the ETT in each of three intubation steps
(from nose into oropharynx(T1), from oropharynx into glottic inlet(T2), and
from glottic inlet to observation of first capnographic trace(T3)). The time
taken will be noted by the Primary investigator using a stopwatch. The
secondary outcomes will be comparing
glottic view as percentage
of glottis opening (POGO) score, modified nasal intubation difficulty score (NIDS) and complications related to NTI. Data
collected will be collected and will be tabulated for statistical
analysis. |