| CTRI Number |
CTRI/2017/02/007809 [Registered on: 08/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of intubation in lateral position with simple laryngoscope versus video laryngoscope |
|
Scientific Title of Study
|
Comparison of endotracheal intubation in lateral position with Macintosh laryngoscope versus AirTraq video laryngoscope |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alpeshkumar Bhavanbhai Hadia |
| Designation |
MD Anaesthesia |
| Affiliation |
Goverment Medical College |
| Address |
257,
haridham society
opp archana school
bombey market to puna gam road
surat
2nd floor,
Anaesthesia department,
new civil hospital
majura Gate
surat
Surat
GUJARAT
395010
India |
| Phone |
9913355736 |
| Fax |
|
| Email |
alpeshhadia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr neeta kavishvar |
| Designation |
MD Anaesthesia, HOD in New civil hospital surat |
| Affiliation |
Goverment Medical College |
| Address |
Flat 2/B prathana apartment,
Ravishankar sankul,
Bhatar char rasta,
surat.
2nd floor,
Anestheasia department,
new civil hospital,
majura Gate,
surat.
Surat
GUJARAT
395017
India |
| Phone |
9825615264 |
| Fax |
|
| Email |
neeta_kavishvar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alpeshkumar Bhavanbhai Hadia |
| Designation |
MD Anaesthesia |
| Affiliation |
Goverment Medical College |
| Address |
257
haridham society
opp archana school
bombey market to puna gam road
surat
2nd floor,
Anaesthesia department,
new civil hospital
majura Gate
surat
Surat
GUJARAT
395010
India |
| Phone |
9913355736 |
| Fax |
|
| Email |
alpeshhadia@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2nd floor,
Anaesthesia department,
New civil hospital,
Majura gate,
Surat-395002 |
|
|
Primary Sponsor
|
| Name |
New Civil Hospital surat |
| Address |
2nd floor,
Anestheasia department,
new civil hospital,
majura gate
surat-395002 |
| 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 alpeshkumar bhavanbhai hadia |
new civil hospial surat |
2nd floor,
Anaesthesia department,
majura gate
surat-395002
Surat
GUJARAT |
9913355736
alpeshhadia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
THOSE PATIENTS ARE REQURIED GENERAL ANAESTHESIA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
laryngoscope |
compare different laryngoscope for the effectiveness in securing airway in lateral position.
two different laryngoscope (airtraq video and macintosh
) compare |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I, II, or III.
Surgery who required general anesthesia with endotracheal tube
|
|
| ExclusionCriteria |
| Details |
1.Increased risk of pulmonary aspiration
2.cervical spine pathology
3.anticipated airway difficulties (i.e., Mallampati grade3& 4 or thyromental distance<6 cm).
4.obesity
5.abnormal teeth or abnormal dentition
6.any cardiorespiratory disease (HTN, COPD, IHD)
7.cerebrovascular disease
8.reflux esophagitis
9.H/O sore throat within 10 days
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
 Incidence of complication of intubation like
Hypoxia (95% of Spo2)
Lip Injury
Mucosal trauma
Bleeding in the oral cavity
arrythmia
Dental injury
Esophageal intubation
Laryngospasm hypertension
hpotension
tachycardia
bradycardia
|
5 mintue |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
 Complication in post-operative period at 8 pm on day of surgery
-post operative sore throat
-Hoarseness of Voice
-mucosal or lip injury
-laryngeal edema
|
12 hours |
|
|
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)
|
17/08/2016 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Securing the airway is primary and essential skill for anesthesiologist. Many times patients’ needs to be intubated in lateral position. The alignment of the oral, pharyngeal and laryngeal axis is not possible in lateral position. So glottis view might be subnormal in this position which can make intubation difficult. For anesthesiologist learning intubation in lateral position is an important skill to develop expert airway management specialist skill. Airtraq is having mirror and prism which reflects the image and the image is visible in viewfinder or video monitor. airtraq does not require alignment oral, pharyngeal and laryngeal axis and it gives high quality and wide view of glottis with surrounding structure. So it is presumed that airtraq might be helpful in making intubation successful in lateral position. There are many studies which compared different video laryngoscope with Macintosh laryngoscope for intubation in lateral position. There is hardly one study which has evaluated airtraq for intubation in lateral position |