| CTRI Number |
CTRI/2024/12/078399 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| 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
|
Comparing the procedure of inserting tube into mouth for general anaesthesia cases using the 3 types of generally used equipment namely Videolaryngoscope, McCoy laryngoscope and Intubating Laryngeal Mask Airway for doing oral intubation that is putting tube through with neck in neutral position |
|
Scientific Title of Study
|
Comparison of Videolaryngoscope, McCoy laryngoscope and Intubating Laryngeal Mask Airway for oro-tracheal intubation in simulated cervical spine immobilization: A Prospective Randomized Comparative Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K B Nalini |
| Designation |
Associate Professor |
| Affiliation |
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
operation theatre, ground floor, department of anaesthesiology
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE
Bangalore KARNATAKA 560001 India |
| Phone |
7760594547 |
| Fax |
|
| Email |
dr_kbnalini@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K B Nalini |
| Designation |
Associate Professor |
| Affiliation |
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
operation theatre, ground floor, department of anaesthesiology
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE
Bangalore KARNATAKA 560001 India |
| Phone |
7760594547 |
| Fax |
|
| Email |
dr_kbnalini@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K B Nalini |
| Designation |
Associate Professor |
| Affiliation |
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
operation theatre, ground floor, department of anaesthesiology
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE
Bangalore KARNATAKA 560001 India |
| Phone |
7760594547 |
| Fax |
|
| Email |
dr_kbnalini@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH, INSTITUTE, shivajinagar, bangalore karnataka - 560001 |
|
|
Primary Sponsor
|
| Name |
dr manoj dean and director |
| Address |
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE, shivajinagar, bangalore, karnataka - 560001 |
| Type of Sponsor |
Government 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 k b nalini |
operation theatre |
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE, shivajinagar, Bangalore KARNATAKA |
7760594547
dr_kbnalini@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethical committee of SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients posted for surgeries under general anaesthesia |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intubating Laryngeal Mask Airway |
comparing the intubation |
| Intervention |
McCoy laryngoscope |
comparing intubation details |
| Comparator Agent |
Videolaryngoscope |
comparing intubation details |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status classes I or II,scheduled for elective surgery under general anesthesia with endotracheal intubation.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to measure intubation success rate.
Ease and success of oral endotracheal intubation were assessed by: a. number of attempts taken, max 2 attempts allowed b.Time taken for intubation c. Need for laryngeal maneuvers or stylet or bougie. |
o, 1, 3, 5 , 10 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters during the intubation procedure (baseline, preintubation, 1, 3, 5mins after intubation) b. |
1, 3, 5 mins interval |
| b. incidence of desaturation |
1, 3, 5 mins |
| Postoperative complications - Incidence of postoperative sore throat (1hr postoperative period) and Incidence of injury to teeth and other soft tissues. |
end operative post extubation |
|
|
Target Sample Size
|
Total Sample Size="105" Sample Size from India="105"
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)
|
30/12/2024 |
| 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="0" Months="3" Days="20" |
|
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
|
All the patients
will be kept nil per oral overnight andpremedicated with tablet pantoprazole 40
mg and tab ondansetron 4mg orally 2hrs prior to the surgery. In the operation
theater, electrocardiogram, noninvasive blood pressure, and pulse oximeter will
be attached and baseline readings will be noted. An adequate gauge intravenous
(i.v.) cannula will be secured and i.v. fluid started. The patient will bepreoxygenated
with 100% oxygen for 3 min. General anesthesia will be induced with fentanyl 2
µg.kg −1 body weight followed by propofol 2–2.5 mg.kg −1 body weight and vecuronium
bromide 0.1 mg.kg −1 body weight to facilitate endotracheal intubation. Mask
ventilation will be done with oxygen (FiO2 1) and isoflurane (MAC 0.6).
Patient’s head and neck will be immobilized in the neutral position using appropriate
size rigid Philadelphia cervical collar. [3]
After 3 min,
oral intubation will be performed using the assigned device by anexperienced
anesthesiologist, who has conducted at least 100 successful intubations using
these devices.
As per group
allocation intubation will be performed using one of the three devices. In
group VL, blade will be inserted in the midline in the oral cavity and advanced
under its monitor vision till its tip reached vallecula. The epiglottis is then
lifted to visualize the glottic opening. A cuffed reinforced endotracheal tube
(ETT) of internal diameter 7.0–7.5 mm for females and 8.0-8.5 mm for males will
be introduced. Correct placement of ETT is confirmed by the appearance of
square wave capnographic trace, bilateral equal breath sounds, and absence of
epigastric sounds.
In group MC, MAC
COY blade will be inserted in the midline in the oral cavity and advanced till
its tip reached vallecula. The epiglottis is then lifted to visualize the
glottic opening. A cuffed reinforced endotracheal tube (ETT) of internal
diameter 7.0–7.5 mm for females and 8.0-8.5 mm for males will be introduced.
Stylet or bougie
will be used for intubation if needed in the above two groups, and will be
noted.
In group IL, the
correct size of ILMA will be selected according to patient’s body weight: 30–50
kg: ILMA number 3, ILMA tube 7.0 mm; 50–80 kg: ILMA number 4, ILMA tube 7.5 mm.
The cuff of ILMA is partially deflated using deflator and upper surface of its
mask is lubricated. Mouth is opened using nondominant hand and ILMA inserted by
dominant hand. The cuff of ILMA is inflated with the requisite amount of air
(size 3: 20 ml, size 4: 40 ml, and size 4: 50 ml) and adjusted to get optimal
ventilation. [6] After confirming the presence of bilateral equal entry and a
square wave capnograph, intubation will be done with lubricated ILMA ETT. The
cuff of ILMA ETT is inflated and intubation confirmed by visualizing square
wave capnograph and bilateral air entry. The ILMA cuff is deflated, and ILMA is
swung out of the pharynx into the oral cavity while applying counter pressure
to the tracheal tube using the stabilizing rod. The ETT connector is replaced
and tube placement reconfirmed using a square wave capnograph. Either of the following
maneuvers is used for troubleshooting any difficulty in intubation through the
ILMA: rotation of ILMA ETT, reinsertion of ILMA ETT, and reinsertion of ILMA of
same or smaller or larger size. [6]
Hypoxemia is defined as fall in SpO2 up to or
below 92%. In case of failure to intubate with the given device in any of the
group within two attempts, patient’s trachea is intubated using macintosh
laryngoscope after removing the cervical collar and will be excluded from the
study. After rechecking the ETT position, patient is ventilated mechanically,
and anesthesia will be maintained with isoflurane (0.6–0.8 MAC) in oxygen and
nitrous oxide (FiO2 0.4). |