| CTRI Number |
CTRI/2023/06/054164 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
19/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing the glottis position by Laryngoscopy and comfortableness of anaesthesiologist in sniffing and simple head extension positions with two different table heights. |
|
Scientific Title of Study
|
Comparison of Laryngoscope view and Intubating conditions obtained by sniffing and simple head extension position at two different operating 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 |
DrChandra SekharT |
| Designation |
Associate Professor |
| Affiliation |
PES Institute of Medical Sciences and Research kuppam |
| Address |
1st Floor, Department of Anaesthesiology,PES Institute of Medical Sciences And Research, Kuppam ,Chithoor.
Chittoor
ANDHRA PRADESH
517425
India |
| Phone |
9440042400 |
| Fax |
|
| Email |
dr.chandu24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandra Sekhar T |
| Designation |
Associate Professor |
| Affiliation |
PES Institute of Medical Sciences and Research kuppam |
| Address |
1st Floor Department of Anaesthesiology PES Istitute of Medical Sciences and Research Kuppam Chittoor.
#209, Hill View Quarters PES Institute of Medical Sciences and Research kuppam
Chittoor
ANDHRA PRADESH
517425
India |
| Phone |
9440042400 |
| Fax |
|
| Email |
dr.chandu24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandra Sekhar T |
| Designation |
Associate Professor |
| Affiliation |
PES Institute of Medical Sciences and Research kuppam |
| Address |
1st Floor Department of Anaesthesiology PES Institute of Medical Sciences and Research Kuppam Chittoor.
Chittoor
ANDHRA PRADESH
517425
India |
| Phone |
9440042400 |
| Fax |
|
| Email |
dr.chandu24@gmail.com |
|
|
Source of Monetary or Material Support
|
| PES INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, KUPPAM, CHITTOOR. |
|
|
Primary Sponsor
|
| Name |
SPONSOR NO NEED |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
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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 CHANDRA SEKHAR T |
PES INSTITUTE OF MEDICAL SCIENCES ANC RESEARCH |
1st FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, PES INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, KUPPAM, CHITTOOR DISTRICT
Chittoor
ANDHRA PRADESH |
9440042400
dr.chandu24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee,pew institute of medical sciences and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, (3) ICD-10 Condition: G00-G99||Diseases of the nervous system, (4) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (5) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
patient head in simple head extension with table height at the anesthesiologist xiphisternum and nipple level. |
omparing the Cormack Lehane grade and anesthesiologist comfortness during intubation in patient head in simple head extension with table height at the anesthesiologist xiphisternum and nipple level. |
| Comparator Agent |
patients head at the standard sniffing position with table height at the anesthesiologist xiphisternal level. |
comparing the Cormack Lehane grade and anesthesiologist comfortness during intubation in patient head in sniffing position with table height at the anesthesiologist xiphisternum level following time periods. basal, at the time of induction ,at the time of intubation and 1,2,3 min after intubation. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60 years
ASA grade I and II
Surgeries undergoing under GA
|
|
| ExclusionCriteria |
| Details |
Obese patients, (BMI>30)
Unstable Cervical spine
Patients with congenital or acquired airway abnormalities
Patients with lose teeth and edentulous jaws
Patients requiring rapid sequence induction
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
i) Successful intubation with reference to ease and duration of Laryngoscopy and
intubation
ii) Cormack- Lehane grading
iii) Number of attempts |
At the time of Intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i) pressor response
ii) Airway injury
iii) Anaesthesiologist comfort |
basal, at the time of Induction, at the time of Intubation, 1,3,5 min after Intubation |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/07/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
- Laryngoscopy
and endotracheal intubation is a very basic procedure to be mastered by
all anaesthesiologists. Positioning the patient head at proper height
assumes a very high importance to complete the task. Heath highlighted the
benefits of using an adjustable operating table and the ergonomic benefits
of different heights—high during cannulation to prevent back discomfort, a
bit lower for airway management, and even lower for short trainees. It has
been suggested that the patient’s face should be placed at the height of
the anaesthetist’s xiphoid process for comfortable intubation without
requiring the anaesthetist to bend his/her back.
H.C.Lee studied
patients face at 4 different landmarks relative to the anaesthesiologist body
and concluded that higher operating table position provide better laryngoscopic
view and less discomfort during tracheal intubation. Smitha prakash studied two different head positions like
sniffing position and simple head extension for laryngoscopic view and
intubation difficulty in adults and concluded that sniffing position is
superior to simple head extension with regard to ease of intubation and has
assessed by Intubation Difficulty Scale(IDS). Presently we will be conducting the study to compare the ease of laryngoscopy and endotracheal
intubation in sniffing and simple head extension position at two different
operating table heights namely xiphisternum and nipple level relative to the
performing Anesthesiologist.
|