| CTRI Number |
CTRI/2018/08/015169 [Registered on: 02/08/2018] Trial Registered Prospectively |
| Last Modified On: |
28/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of difficulty in securing patient airway at varying operating table heights. |
|
Scientific Title of Study
|
Assessment of ease of laryngoscopy at varying table heights. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavya Goel |
| Designation |
Secondary DNB Resident |
| Affiliation |
MAX Super Speciality Hospital Vaishali |
| Address |
Department of Anaesthesia
O.T Complex 2nd Floor
MAX Super Speciality Hospital
W-3 Sector-1
Vaishali, Ghaziabad
Uttar Pradesh
Department of Anaesthesiology
O.T Complex 2nd Floor
MAX Super Speciality Hospital
W-3 Sector-1
Vaishali, Ghaziabad
Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
8810626961 |
| Fax |
|
| Email |
goel.kavya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv Aggarwal |
| Designation |
Senior Consultant |
| Affiliation |
MAX Super Speciality Hospital Vaishali |
| Address |
Department of Anaesthesia
O.T Complex 2nd Floor
MAX Super Speciality Hospital
W-3 Sector-1
Vaishali, Ghaziabad
Uttar Pradesh
Department of Anaesthesia
O.T Complex 2nd Floor
MAX Super Speciality Hospital
W-3 Sector-1
Vaishali, Ghaziabad
Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9990696937 |
| Fax |
|
| Email |
rajivaggy@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavya Goel |
| Designation |
Secondary DNB Resident |
| Affiliation |
MAX Super Speciality Hospital Vaishali |
| Address |
Department of Anaesthesia
O.T Complex 2nd Floor
MAX Super Speciality Hospital
W-3 Sector-1
Vaishali, Ghaziabad
Uttar Pradesh
Department of Anaesthesia
O.T Complex 2nd Floor
MAX Super Speciality Hospital
W-3 Sector-1
Vaishali, Ghaziabad
Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
8810626961 |
| Fax |
|
| Email |
goel.kavya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
O.T Complex 2nd Floor
MAX Super Speciality Hospital
W-3 Sector-1
Vaishali, Ghaziabad
Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
MAX Super Speciality Hospital Vaishali |
| Address |
W-3 Sector-1 Vaishali
Ghaziabad
Uttar Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kavya Goel |
Anaesthesia Department |
Department of Anaesthesia
O.T Complex 2nd Floor
MAX Super Speciality Hospital
W-3 Sector-1
Vaishali, Ghaziabad
Uttar Pradesh
Ghaziabad
UTTAR PRADESH |
810626961
Goel.kavya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Max Super speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Changing Operating Table Height |
Different Table Heights, Umbilicus, Xiphisternum, Nipple |
| Comparator Agent |
Cormack Lehane Grade, Wrist deviation, arm elevation, neck flexion, lower back flexion, head extension |
Angles will be calculated using photographs taken during laryngoscopy and using Adobe photoshop CS6 software |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing surgery under General Anaesthesia at MAX Super Speciality Hospital Vaishali
ASA Grade I, II, III
|
|
| ExclusionCriteria |
| Details |
Patients with ASA Grade IV
Patients with anticipated difficult airway. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is expected to be the determination of the table height providing the least discomfort during laryngoscopy and intubation. |
1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the table height which provides the best laryngeal view with the least discomfort. |
1 year. |
| To determine the table height which provides the least head extension in the patient while providing the best laryngeal views. |
1 year. |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/08/2018 |
| Date of Study Completion (India) |
31/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 patient’s airway is of prime importance to the anaesthesiologist and the
ease of laryngosopy and intubation depends on the best laryngeal view obtained.
This is greatly influenced by the height of the operating table at the time of
laryngoscopy. Furthermore the ease of intubation leads to lesser stress on the
patient as well as the anaesthesiologist, leading to a lesser postoperative
discomfort to the patient and better work performance by the doctors. This
study aims to simultaneously evaluate the effect of table height on the ease of
laryngoscopy and intubation for the patient as well as the anaesthesiologist by
measuring the best laryngeal view, the degree of discomfort to the
anaesthesiologist and the head extension required of the patient’s head during
laryngoscopy at three different table heights.
|