| CTRI Number |
CTRI/2024/05/067394 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two different airway assessment parameters as a predictor of difficulty in visvalising vocal cords while stabilising the neck in neutral position during anaesthesia in adult patients |
|
Scientific Title of Study
|
Comparison of neck circumference to interincisor gap ratio with thyromental height test as a predictor of difficult laryngoscopy with manual-in line stabilisation maneuver during endotracheal intubation in adult patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTB Hospital,Delhi |
| Address |
731 A,7th floor,OT Block, Department of anesthesiology and critical care ,UCMS and GTB Hospital, Delhi
New Delhi
DELHI
110093
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTB Hospital,Delhi |
| Address |
731 A,7th floor,OT Block, Department of anesthesiology and critical care ,UCMS and GTB Hospital, Delhi
New Delhi
DELHI
110093
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya |
| Designation |
Pg student |
| Affiliation |
UCMS and GTB Hospital |
| Address |
2nd floor, OT Block, Department of anesthesiology and critical care ,UCMS and GTB Hospital, Delhi
New Delhi
DELHI
110093
India |
| Phone |
9991524607 |
| Fax |
|
| Email |
Priyadalal616@gmail.com |
|
|
Source of Monetary or Material Support
|
| UCMS AND GTB HOSPITAL ,DELHI,110093 ,INDIA |
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
GTB Hospital,Dilshad garden, New delhi,110093,INDIA |
| 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 |
| DrRuchi Kapoor |
UCMS and GTB Hospital |
Department of Anesthesiology and Critical Care, 2nd floor, OT Block, GTB Hospital ,Dilshad garden ,110093 ,India
East
DELHI |
9560678023
rudoc@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECHR Institutional Ethics Committee- Human Resources |
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
|
| Type |
Name |
Details |
| Intervention |
Neck circumference,interincisor gap |
Neck circumference will be measured using soft measuring tape and interincisor gap will be measured using vernier calliper before induction (0 hour) |
| Comparator Agent |
Thyromental height |
Thyromental height test will be measured between anterior border of thyroid to mentum by using vernier calliper before induction (0 hour) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Consenting adult patients scheduled for elective surgeries under general anesthesia with no restriction of cervical spine movement. |
|
| ExclusionCriteria |
| Details |
Following patients are excluded from the study-
1) Anatomical abnormality of neck , mandible
2)Upper airway abnormality (maxillofacial tumor, trauma, carcinoma tongue)
3) Mouth opening less than 1.5 cm
4) Patient with cervical spinal abnormalities
5) Patient with cervical spine trauma |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Sensitivity of Neck circumference to Interincisor gap ratio (NC/IIG ratio) with thyromental height test (TMHT) as a predictor of difficult laryngoscopy with MILS during intubation in adult patients posted for surgery under general anesthesia. |
After data collection from all participants of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparision of NC/IIG ratio with TMHT as a predictor of difficult laryngoscopy with MILS maneuver during intubation with respect to following: Specificity, Positive Predictive Value(PPV), Negative Predictive Value(NPV).
2. Sensitivity and specificity of Mallampati classification as a predictor of difficult laryngoscopy during MILS maneuver.
3. Comparison of Sensitivity and specificity of NC/IIG ratio with TMHT as a predictor of difficult intubation.
4. Sensitivity and specificity of Mallampati classification as a predictor of difficult intubation. |
After data collection from all participants of study |
|
|
Target Sample Size
|
Total Sample Size="155"
Sample Size from India="155"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neck circumference/Interincisor gap ratio (NC/IIG) and Thyromental height test(TMHT)are relatively newer parameter which does not required neck extension may be useful in predicting difficult laryngoscopy in patients. TMHT measures the height between the anterior border of the mentum and thyroid cartilage with the patient lying supine. Manual in-line stabilization refers to a technique used in emergency medical situations to immobilize and support the head and neck of a person suspected to have suffered a spine or neck injury. Therefore this analytical study is designed to compare NC/IIG ratio with TMHT as a predictor of difficult laryngoscopy with MILS during intubation in adult patients posted for elective surgery as both these tests do not require neck extension in patients and so we hypothesize these tests could be useful in patients with restricted neck movement. |