| CTRI Number |
CTRI/2024/01/061818 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the efficacy of placement of airway tube in windpipe between direct visualization of larynx by using McCoy blade and indirect visualization of larynx by using video laryngoscope in patients who are scheduled for cervical spine surgery. |
|
Scientific Title of Study
|
Comparison of direct laryngoscopy with McCoy blade & BPL video laryngoscopy for intubation in patients undergoing elective cervical spine surgery. |
| 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 Mohammad Aleem Ansari |
| Designation |
Junior resident |
| Affiliation |
Uttar Pradesh university of medical sciences Saifai Etawah |
| Address |
Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah
Etawah UTTAR PRADESH 206130 India |
| Phone |
8750843632 |
| Fax |
|
| Email |
medico398@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Atit Kumar |
| Designation |
Junior grade Professor |
| Affiliation |
Uttar Pradesh university of medical sciences Saifai Etawah |
| Address |
Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah
Etawah UTTAR PRADESH 206130 India |
| Phone |
9453471671 |
| Fax |
|
| Email |
dr_atit@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Atit Kumar |
| Designation |
Junior grade Professor |
| Affiliation |
Uttar Pradesh university of medical sciences Saifai Etawah |
| Address |
Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah
Etawah UTTAR PRADESH 206130 India |
| Phone |
9453471671 |
| Fax |
|
| Email |
dr_atit@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh university of medical sciences Saifai Etawah |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh university of medical sciences Saifai Etawah |
| Address |
Uttar Pradesh university of medical sciences Saifai Etawah Uttar Pradesh India PIN code 206130 |
| 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 Mohammad Aleem Ansari |
Uttar Pradesh university of medical sciences |
Department of anesthesiology and critical care Etawah Uttar Pradesh Etawah UTTAR PRADESH |
8750843632
medico398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES SAIFAI ETAWAH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S129||Fracture of neck, unspecified, (2) ICD-10 Condition: Q069||Congenital malformation of spinalcord, unspecified, (3) ICD-10 Condition: G952||Other and unspecified cord compression, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BPL video laryngoscopy |
In this group video laryngoscopy will be performed by using the BPL video laryngoscope after giving premedication, induction agent and muscle relaxant. Duration of intubation of endotracheal tube into the trachea from handling of video laryngoscopy to appearance of capnogram on monitor will be noted and other parameters like Modified Cormack Lehane grading, ease of intubation and hemodynamic parameters for 10 minutes will also be monitored. |
| Comparator Agent |
Direct laryngoscopy with McCoy blade |
In this group direct laryngoscopy will be performed by using the McCoy blade after giving premedication, induction agent and muscle relaxant. Duration of intubation of endotracheal tube into the trachea from handling of direct laryngoscope with McCoy blade to appearance of capnogram on monitor will be noted and other parameters like Modified Cormack Lehane grading, ease of intubation and hemodynamic variability for 10 minutes will also be monitored. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Conscious with cervical spine unstable patients
2.Age 18 years to 65 years
3.ASA class 1 and ASA class |
|
| ExclusionCriteria |
| Details |
1.Known history of difficult intubation
2.Mouth opening less than 3 fingers
3.Thyromental distance less than 6.5 centimeter
4.Body mass index more than 35 kg-m2
5.Known risk of aspiration,
6.Failed intubation in unanticipated difficult airway. |
|
|
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 determine the duration of the tracheal intubation procedure in BPL video laryngoscopy and Direct laryngoscopy with McCoy blade.
|
90 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the visualization of airway between the two groups using Modified Cormack Lehane grading
2.Ease of intubation
3.To determine intubation difficulty score
4.To compare the hemodynamic stability while the insertion of endotracheal tube into trachea |
10 minutes |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/01/2024 |
| Date of Study Completion (India) |
30/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Intubating the trachea and securing the airway remains a challenge, although it is a routine practice for the anesthesiologist. There is no single factor to predict the existence of a difficult airway, so difficult airway is not recognized until the induction of anesthesia. Difficult intubation is very subjective and it is difficult to measure the degree of difficulty, as previous studies say that in difficult airway management video laryngoscope improve Cormack- Lehane grade and achieve the same or a higher intubation success rate in less time, compared with direct laryngoscope. After getting clearance from ethical committee, to refine the previous studies we are conducting a study on 60 patients of elective cervical spine surgery and the patients are divided in two groups by random number table with 30 patients in each group, to compare efficacy of BPL video laryngoscopy and direct laryngoscopy with McCoy blade for intubation in patients undergoing elective cervical spine surgery. Patients will be intubated by using BPL video laryngoscope and direct laryngoscope with McCoy blade of respective group patients after giving premedication, preoxygenation for 3 minutes, induction agent and muscle relaxants. The primary objective is to find duration of the tracheal intubation by using BPL video laryngoscope and direct laryngoscope with McCoy blade. The secondary objectives are comparing the visualization of airway between the two groups using Modified Cormack Lehane grading, ease of intubation, to determine intubation difficulty score, to compare the hemodynamic stability while and after insertion of ET Tube into trachea. |