| CTRI Number |
CTRI/2021/08/035912 [Registered on: 25/08/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| 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
|
To compare the different laryngoscopes king vision, Mac coy and Macintosh laryngoscopes for tracheal intubation in cases of mucormycosis scheduled for surgery. |
|
Scientific Title of Study
|
Comparative evaluation of King version video-laryngoscope, Mac-Coy and Macintosh laryngoscopes for tracheal intubation in patients scheduled for mucormycosis surgery in a tertiary care hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Michell Gulabani |
| Designation |
Assistant professor |
| Affiliation |
Department of anaesthesia UCMS/GTBH |
| Address |
Department of Anaesthesia
University college of Medical Sciences
Guru Teg Bahadur Hospital
Delhi
Department of Anaesthesia
University college of Medical Sciences
Guru Teg Bahadur Hospital
Delhi
East
DELHI
110017
India |
| Phone |
9873657500 |
| Fax |
|
| Email |
michellgulabani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Michell Gulabani |
| Designation |
Assistant professor |
| Affiliation |
Department of anaesthesia UCMS/GTBH |
| Address |
Department of Anaesthesia
University College of Medical Sciences
Guru Tekh Bahadur Hospital
Delhi
Department of Anaesthesia
University College of Medical Sciences
Guru Tekh Bahadur Hospital
Delhi
East
DELHI
110017
India |
| Phone |
9873657500 |
| Fax |
|
| Email |
michellgulabani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Michell Gulabani |
| Designation |
Assistant professor |
| Affiliation |
Department of anaesthesia UCMS/GTBH |
| Address |
Department of Anaesthesia
University College Of Medical Sciences
Guru Tekh Bahadur Hospital
Delhi
Department of Anaesthesia
University College Of Medical Sciences
Guru Tekh Bahadur Hospital
Delhi
East
DELHI
110017
India |
| Phone |
9873657500 |
| Fax |
|
| Email |
michellgulabani@gmail.com |
|
|
Source of Monetary or Material Support
|
| University college of medical sciences
Guru Tekh bahadur Hospital Delhi |
|
|
Primary Sponsor
|
| Name |
UCMSGTBH |
| Address |
Dilshad garden
Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Michell Gulabani |
UCMS/GTBH |
Department of Anaesthesia
UCMS
East
DELHI |
09873657500
michellgulabani@gmail.com |
| Dr Michell Gulabani |
UCMS/GTBH |
Operation theatre for Mucormycosis surgery
East
DELHI |
09873657500
michellgulabani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committe /HR- UCMS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: B488||Other specified mycoses, (3) ICD-10 Condition: B488||Other specified mycoses, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparasion of King vision, Mac Coy and Macintosh laryngoscopes for tracheal intubation of patients posted for Mucormycosis surgery |
A structured questionnaire as enclosed as patient record form (Annexure 1) will be used for recording the airway and hemodynamic data. Patients in the A group will be intubated with King ‘s vision video laryngoscope , those belonging to Group B Mc Coy laryngoscope will be used and in Group C Macintosh laryngoscope after induction of anesthesia. . On shifting the patient to the operation theater, all the monitoring devices shall be attached. An 18 G IV infusion line will be started, and all patients shall be hydrated with approximately 8-10 ml/kg of normal saline before induction. All hemodynamic data will be measured on arrival in OT, before induction, after induction, and at 1, 2, 3, 5 and 7 minutes after intubation by an independent observer. Anesthesia will be induced with Injection propofol till the loss of response to verbal commands and fentanyl 2μg/kg. After giving injection succinylcholine 2mg/kg and ventilating the patients with O2 100% for 60 seconds , laryngoscope depending on the group will be used and intubation shall be performed by an experienced anesthesiologist with cuffed oral endotracheal tube . |
| Comparator Agent |
Comparative evaluation of King vision video-laryngoscope, Mac-Coy and Macintosh laryngoscopes for tracheal intubation in patients scheduled for mucormycosis surgery in a tertiary care hospital: A prospective randomized study. |
A complete Pre-anesthetic checkup including complete airway assessment based on standard indices will be performed prior to their scheduled allotment into the three different study groups. Patients will be randomly allocated to the three groups by a computer generated random number table after obtaining written and informed consent. A structured questionnaire as enclosed as patient record form (Annexure 1) will be used for recording the airway and hemodynamic data. Patients in the A group will be intubated with King ‘s vision video laryngoscope , those belonging to Group B Mc Coy laryngoscope will be used and in Group C Macintosh laryngoscope after induction of anesthesia. . On shifting the patient to the operation theater, all the monitoring devices shall be attached. An 18 G IV infusion line will be started, and all patients shall be hydrated with approximately 8-10 ml/kg of normal saline before induction. All hemodynamic data will be measured on arrival in OT, before induction, after induction, and at 1, 2, 3, 5 and 7 minutes after intubation by an independent observer. Anesthesia will be induced with Injection propofol till the loss of response to verbal commands and fentanyl 2μg/kg. After giving injection succinylcholine 2mg/kg and ventilating the patients with O2 100% for 60 seconds , laryngoscope depending on the group will be used and intubation shall be performed by an experienced anesthesiologist with cuffed oral endotracheal tube . |
| Comparator Agent |
Laryngoscopes |
3 GROUPS will be compared depending on the type of laryngoscope used . King vision, Mac Coy and Macintosh laryngoscopes |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All ASA1 and ASA2 patients in the age group of 18- 65 years will be included in this prospective randomized study. |
|
| ExclusionCriteria |
| Details |
1 Morbid Obesity
2 Pregnancy
3 Bleeding diathesis
4 Severe cardiac or respiratory insufficiency
5 Progressive neurological disease |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mouth opening after induction, Cormack- Lehane grade, time to successful intubation, number of attempts, any adjuncts used for airway optimization |
Hemodynamic variables before induction, after induction, 1,2, 3, 5 and 7 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic variables like heart rate, systolic blood pressure, diastolic blood pressure, mean blood pressure , ECG and SP02 |
Pre induction, post induction, 1, 2, 3, 5, 7 minutes of intubation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2021 |
| Date of Study Completion (India) |
31/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Mucormycosis ,an emerging angioinvasive fungal infection is associated with high morbidity and mortality. Rhino orbital cerebral mucormycosis (ROCM) is characterised by progressive fungal invasion of the hard palate, paranasal sinuses, orbit, and brain is the commonest variant.. Patients with ROCM , may experience difficult mask ventilation and endotracheal intubation as a result of epiglottitis and supraglottic edema associated with fungal debris. The armamentarium of the anesthesiologist has a variety of options for difficult intubation . King vision video laryngoscope is one of the latest laryngoscopes as an aid in difficult airway. However, relative efficacy of this device in comparison with the Macintosh laryngoscope and Mc Coy laryngoscope has not been compared in mucormycosis patients. Therefore, this randomized, prospective study will be planned to compare the effectiveness of Macintosh, McCoy, and King Vision video laryngoscopes to compare the ease of intubation and hemodynamic variables in mucormycosis patients posted for elective surgery . 90 consenting adult patients aged 18-65 years of age of either sex ASA Grade 1 and ASA Grade 2 undergoing elective surgery under general anesthesia with endotracheal intubation will be included in this prospective randomized study protocol. The end points of the primary objectives are Mouth opening post induction, Cormack-Lehane grade, time to successful intubation and number of attempts to successful intubation.The secondary objectives will be a heart Rate, Systolic blood pressure and diastolic blood pressure. Patients in the A group will be intubated with King ‘s vision video laryngoscope , those belonging to Group B Mc Coy laryngoscope will be used and in Group C Macintosh laryngoscope after induction of anesthesia. Sample size will be calculated at 95 % significance level and power of 80%. An alpha error of 0.05 and beta error of 0.2 incorporating three equal size groups of 30 each will be taken. The total number of patients being enrolled will be 90. The second wave of the COVID 19 pandemic has seen a surge in the cases of mucormycosis and hence optimal anesthetic management of patients being scheduled for anaesthesia is vital. |