| CTRI Number |
CTRI/2018/01/011552 [Registered on: 24/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Macintosh blade and Macdoshi blade in general anaesthesia. |
|
Scientific Title of Study
|
Comparison of laryngoscopic view ,ease of tracheal intubation and hemodynamic response using Macintosh blade and Macdoshi blade in general anaesthesia for elective surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr L Sai Anand |
| Designation |
Junior resident |
| Affiliation |
kasturba medical college,manipal. |
| Address |
Department of Anaesthesiology ,CSOT Block,Kasturba medical college,manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9959186090 |
| Fax |
|
| Email |
sai.nand43@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Sara M Jacob |
| Designation |
Senior resident |
| Affiliation |
Kasturba medical college,manipal |
| Address |
Department of Anaesthesiology ,CSOT Block,Kasturba medical college,manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9500574751 |
| Fax |
|
| Email |
nishasara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siri Kandavar |
| Designation |
Assistant professor |
| Affiliation |
Kasturba medical college,manipal |
| Address |
Department of Anaesthesiology ,CSOT Block,Kasturba medical college,manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739868002 |
| Fax |
|
| Email |
sirikandavar16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,Manipal University,Manipal,Udipi,Karnatka |
|
|
Primary Sponsor
|
| Name |
Dr L Sai Anand |
| Address |
department of anaesthesiology,csot block,kasturba medical college,manipal 576104. |
| Type of Sponsor |
Other [PRIMARY INVESTIGATOR] |
|
|
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 L Sai Anand |
kasturba medical college |
department of anaesthesiology,csot block,kasturba medical college,manipal 576104.
Udupi
KARNATAKA |
9959186090
sai.nand43@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee,Kasturba Hospital,Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient under going elective surgery under general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MacDoshi blade |
MacDoshi blade will be used in patients under going elective surgery under general anaesthesia for endotracheal intubation. |
| Comparator Agent |
Maciniosh blade |
Macintosh is the conventionally used laryngoscopic blade used in patients posted for elective surgery under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex of at least 18 years of age to 60 years , with body mass index (BMI) of 18.5 to 29.5 kilograms per meter square belonging to American Society of Anaesthesiologist Physical Status 1 or 2, scheduled for elective surgery under general anaesthesia requiring orotracheal intubation |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Anticipated difficult airway.
3.Pregnancy
4.Cervical spine pathology
5.Increased risk of pulmonary aspiration
6.Buck teeth
7.Hypertensive patient on beta blockers
8.Ischemic heart disease
9. Patients with increased intracranial pressure and head injury
10. Reactive airway disease
11. BMI > 30 kg/m2
12. Heart block
13. Hemodynamic instability
14. Cognitive dysfunction/ psychiatric disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Laryngoscopic view of glottis |
One time measurement at the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Ease of intubation.
2.Time for intubation.
3.Hemodynamic response
|
Ease of intubation and time of intubation are one time measurements performed during the process of intubation,whereas haemodynamic response is measured at the following 6 timepoints:
baseline vitals before induction of anesthesia (TB),
at the time of intubation (T0),
1 minute after intubation (T1),
3 minutes after intubation (T3),5 minutes after intubation(T5),10 minutes after intubation(T10).
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/05/2017 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil currently |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is basically comparing two laryngoscopic blades used for orotracheal intubation. Conventionally used blade is Macintosh ,the other blade is MacDoshi blade. Blades will be used to assess laryngoscopic view using the modified Cormack- Lehane grading , the ease of intubation using Arino’s scale,time of intubation and hemodynamic changes .Informed consent will be taken and patient will be allocated to either group using a computer generated random sequence generator .Following routine induction of anaesthesia, patient will be intubated with assigned blade by observer 2.while observer 1 who is blinded for the blade being used will be recording hemodynamic variables.Observer 3 will note time for intubation and chart modified Cormack- Lehane grade,Arino’s scale for ease of intubation as told by observer 2. |