| CTRI Number |
CTRI/2020/11/029369 [Registered on: 25/11/2020] Trial Registered Prospectively |
| Last Modified On: |
24/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Insertion of tube in the respiratory pathway using two different types of laryngoscope used for introduction |
|
Scientific Title of Study
|
A Comparative Study of Haemodynamic Response Following Laryngoscopy and Endotracheal Intubation with Direct Laryngoscope versus Video Laryngoscope Intubation in Patients Undergoing General Anaesthesia |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahalakshmi |
| Designation |
Postgraduate - Junior Resident |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology, PSGIMSR, Coimbatore
-
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9003592234 |
| Fax |
2573833 |
| Email |
deterministicmaha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R Arun Kumar |
| Designation |
Associate Professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology,
PSG IMSR, Coimbatore
-
Coimbatore
TAMIL NADU
641004
India |
| Phone |
09944113440 |
| Fax |
- |
| Email |
shivaaniarun76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Arun Kumar |
| Designation |
Associate Professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology, PSG IMSR, Coimbatore
-
Coimbatore
TAMIL NADU
641004
India |
| Phone |
09944113440 |
| Fax |
- |
| Email |
shivaaniarun76@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self funded |
| Address |
- |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| R Arun Kumar |
PSG IMSR |
Department of Anaesthesiology,
Peelamedu, Coimbatore
Coimbatore
TAMIL NADU |
9944113440
-
shivaaniarun76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PSG Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventionally endotracheal intubation |
Mac intosh laryngoscopes size 3 or 4. Duration - Baseline, 1 min, 3 min, 5 min, 10 mins |
| Comparator Agent |
Video laryngoscope |
D blade video laryngoscope. Baseline, 1 min, 3 mins, 5 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective laparoscopic surgeries under general anaesthesia,Patients aged above 18 – below 60 years, Both gender, ASA 1 and 2, Mallampatti class I and II
|
|
| ExclusionCriteria |
| Details |
Pregnancy,BMI > 35,Emergency surgery,
Conditions causing raised intra cranial pressure, ASA above 3, Mallampatti III and IV
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the haemodynamic response following laryngoscopy and endotracheal intubation with direct laryngoscope versus video laryngoscope intubation in patients undergoing general anaesthesia. |
Baseline, 1,2,3,5,10 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameter |
Baseline, 1 min, 2 min, 5 mins and 10 mins |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/11/2020 |
| 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="4"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laryngoscopy and endotracheal intubation may cause different haemodynamic stress response. The reflex responses to stimulation of orppharyngeal and upper airway receptors include glottic closure, hypertension and reflex broncho constriction. There are studies comparing the use of various laryngoscopes with regard to endotracheal intubation and in our study we have compared the stress response with conventional versus videolaryngoscopes. Under strict standard guidelines of antiaspiration prophylaxis patient prepared for general anaesthesia. Baseline vital recordings o fHeart rate, Systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation parameteres were noted with basline, during and after laryngoscopy and endotracheal intubation, 5 minutes and 10 minutes. Statistical analysis would be done using Levene’s test for equality of variance and paired t test. Value less than 0.05 would be statistically significant. |