| CTRI Number |
CTRI/2025/03/081657 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Examine Anterior Soft Neck tissue by Ultrasonographic Parameters versus Clinical Parameters in Predicting Difficult Endotracheal Tube Intubation in Patients Undergoing Elective Surgery Under General Anaesthesia |
|
Scientific Title of Study
|
Comparative Evaluation of Anterior Soft Neck Tissue by Ultrasonographic Parameters Versus Clinical Parameters to Predict Difficult Airway in Patients Undergoing Elective Surgery under General Anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Rani |
| Designation |
Junior resident |
| Affiliation |
Guru Gobind Singh medical college and hospital,Faridkot |
| Address |
Department of Anaesthesiology,GGSMCH Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
8968694700 |
| Fax |
|
| Email |
Priyankasheenugarg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haramritpal Kaur |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh medical college and hospital,Faridkot |
| Address |
Department of Anaesthesiology,GGSMCH Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9878088013 |
| Fax |
|
| Email |
amritk_dr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Rani |
| Designation |
Junior resident |
| Affiliation |
Guru Gobind Singh medical college and hospital,Faridkot |
| Address |
Department of Anaesthesiology,GGSMCH Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
8968694700 |
| Fax |
|
| Email |
Priyankasheenugarg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,GGSMCH,Faridkot,India,151203 |
|
|
Primary Sponsor
|
| Name |
Dr Haramritpal Kaur |
| Address |
Department of Anaesthesiology, GGSMCH, Faridkot,India,151203 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sarvjeet Kaur |
Department of Anaesthesiology, GGSMCH, Faridkot,151203,India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Rani |
Guru Gobind Singh Medical College and Hospital |
Department of
Anaesthesiology, Guru
Gobind Singh Medical
College and Hospital,
Faridkot
Faridkot
PUNJAB |
8968694700
Priyankasheenugarg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of GGSMCH, Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R239||Unspecified skin changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To assess clinical parameters to predict difficult airway. |
Neck circumference, Modified Mallampati score(MMS), Thyromental distance (TMD) |
| Intervention |
Ultrasound |
In the pre- operating holding
area with the patient lying
supine and in sniffing
position,the sonographic
assessment will be done with
the high frequency
(7.5Mhz)linear probe, placed in
the submandibular area in the
midline for 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anaesthesia.
American Society of Anaesthesiologist grade I and II |
|
| ExclusionCriteria |
| Details |
Patients with deformity of face and neck.
History of surgery or trauma of face, neck, larynx, pharynx and epiglottis.
Past history of difficult intubation.
Pregnant women.
Cervical- spine abnormalities.
Rapid sequence induction conditions.
Edentulous patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate anterior neck soft tissue by clinical parameters to predict difficult
airway in patients undergoing elective surgery under general anaesthesia.
2. To evaluate anterior neck soft tissue by ultasonographic parameters to predict
difficult airway in patients undergoing elective surgery under general
anaesthesia.
3. To compare clinical parameters with ultasonographic parameters to predict
difficult airway in patients undergoing elective surgery under general
anaesthesia. |
In the pre- operating holding
area with the patient lying
supine and in sniffing
position,the sonographic
assessment will be done with
the high frequency
(7.5Mhz)linear probe, placed in
the submandibular area in the
midline for 10 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate anterior neck soft tissue by ultasonography & clinical parameters to predict difficult
airway in patients undergoing elective surgery. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
13/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Airway related morbidity due to inability to anticipate difficult airway is one of the primary concern for anesthesiologist during airway management. Airway related complications amounts in significant number of litigation against anaesthesiologist.Predicting difficult intubation by evaluation of airway is very important in anaesthesia practice. There are several clinical predictors for assessment of difficult airway. But an unanticipated difficult airway is a dreadful nightmare even for an experienced anaesthesiologist, as it can cause life-threatening anaesthesia-related morbidity and mortality. Aims and objectives 1. To evaluate anterior neck soft tissue by clinical parameters to predict difficult airway in patients undergoing elective surgery under general anaesthesia. 2. To evaluate anterior neck soft tissue by ultasonographic parameters to predict difficult airway in patients undergoing elective surgery under general anaesthesia. 3. To compare clinical parameters with ultrasound parameters to predict difficult airway in patients undergoing elective surgery under general anaesthesia. |