| CTRI Number |
CTRI/2021/09/036439 [Registered on: 13/09/2021] Trial Registered Prospectively |
| Last Modified On: |
10/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to compare airway assessment tests in combination or individually with Intubation Difficulty Scale in patients undergoing Direct Laryngoscopy and Endotracheal Intubation. |
|
Scientific Title of Study
|
An observational study to compare airway assessment tests in combination or individually with Intubation Difficulty Scale in patients undergoing Direct Laryngoscopy and Endotracheal Intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Gupta |
| Designation |
PG Resident |
| Affiliation |
Teerthanker mahaveer university |
| Address |
Department of anaesthesia, Teerthanker mahaveer medical college and research institute, Delhi road,bagadpur
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9625709671 |
| Fax |
|
| Email |
gupta04nisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G S jheetay |
| Designation |
Professor and HOD |
| Affiliation |
Teerthanker mahaveer university |
| Address |
Department of anaesthesia Teerthanker mahaveer medical college Delhi road bagadpur
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9625709671 |
| Fax |
|
| Email |
drgurdeep.medical@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Gupta |
| Designation |
PG Resident |
| Affiliation |
Teerthanker mahaveer university |
| Address |
Department of anaesthesia Teerthanker mahaveer medical college Delhi road bagadpur
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9625709671 |
| Fax |
|
| Email |
gupta04nisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthankar mahaveer University |
|
|
Primary Sponsor
|
| Name |
Teerthanker mahaveer medical and research college |
| Address |
moradabad delhi road |
| Type of Sponsor |
Private 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 |
| Nisha Gupta |
Teerthanker mahaveer medical college and research center |
Department of Anaesthesia, Teerthankar mahaveer medical College moradabad delhi road bagadpur
Moradabad
UTTAR PRADESH |
9625709671
gupta04nisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)written informed consent to be taken.
2)ASA physical status I,II,III schduled or general anaesthesia.
3) patients with BMI 18.5 -25.9kg/m2. |
|
| ExclusionCriteria |
| Details |
Patients with head and neck pathologies, trauma, radiation, cervical spine pathology requiring specific manipulation.
Patients with airway anomalies.
Patients with the need of rapid sequence induction/intubation under cricoid pressure (obstetric cases included) or awake intubation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare preoperative assessment scores with Intubation Difficulty Score (IDS).
|
at the time of PAC and at laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare preoperative assessment scores with Intubation Difficulty Score (IDS).
|
at the time of PAC and at laryngoscopy |
|
|
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)
|
15/09/2021 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•In this, I will be using some bed side tests individually plus in combination to predict difficult airway and compare it with Intubation difficulty scale to know there PPV and NPV. •Moreover the tests to be conducted are based on anthropometry which is again geographical based, thus results of previous studies done may not be applicable to every population. I would be concentrating on our hospital population in this study to predict airway assessment tests required for future reference |