| CTRI Number |
CTRI/2022/04/042324 [Registered on: 29/04/2022] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound neck for predicting difficult mask ventilation and difficult laryngoscopy |
|
Scientific Title of Study
|
Prediction of difficult mask ventilation and difficult laryngoscopy by pre-operative
ultrasound-based measurement of airway parameters
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Professor, Department of Anaesthesiology,AIIMS,Bhopal
Bhopal MADHYA PRADESH 462020 India |
| Phone |
9575604490 |
| Fax |
|
| Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S R A N Bhushanam Padala |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Assistant Professor, Department of Anaesthesiology, AIIMS, Bhopal.
Bhopal MADHYA PRADESH 462020 India |
| Phone |
7893562302 |
| Fax |
|
| Email |
padala72@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S R A N Bhushanam Padala |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Assistant Professor, Department of Anaesthesiology, AIIMS, Bhopal.
Sagar MADHYA PRADESH 462020 India |
| Phone |
7893562302 |
| Fax |
|
| Email |
padala72@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical sciences,Bhopal |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical SciencesBhopal |
| Address |
Saket Nagar Bhopal 462020 |
| Type of Sponsor |
Other [Self] |
|
|
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 Vaishali Waindeskar |
All India Institute of Medical Sciences, Bhopal |
2nd and 3rd floor,
Department of anaesthesia,Hospital building,AIIMS,Bhopal Bhopal MADHYA PRADESH |
9575604490
vaishali.anesth@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human 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 |
Adult patients between 18-65 years undergoing elective surgeries under general anesthesia with muscle relaxation and endotracheal intubation in various surgical specialties |
|
| ExclusionCriteria |
| Details |
1. Respiratory distress in the preoperative period
2. Patients with known facial, cervical, pharyngeal and epiglottic cancer
3. Patients with head and neck trauma
4. Patients who have undergone previous thyroid surgery or tracheostomy
5. Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ultrasound based airway parameters-
1. Distance from skin to hyoid bone
2. Distance from skin to thyroid isthmus
3. Thickness of base of the tongue
Conventional clinical assessment-
1. Modified Mallampati grading
2. Upper lip bite test
Body mass index and other demographic variables like age, gender
Cormack-Lehane grading
Han scale grading
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="114" Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/06/2022 |
| Date of Study Completion (India) |
09/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
may publish prospectively after completion of the trail |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The unanticipated difficult airway is a potentially life-threatening event. Predicting the difficulties with airway management currently remains a challenge and the incidence of death and brain damage related to airway management is about 25% of relevant incidents reported during general anesthesia. Several authors have shown that the described risk factors have low predictability in anticipating difficult airway. Future research is needed to develop tests with high sensitivities and to better screen difficult face mask ventilation and failed intubation. Pre-operative ultrasound measurement of the anterior neck soft-tissue thickness at different levels, combined with the commonly used screening tests and risk factor assessment for difficult laryngoscopy might improve the ability to predict difficult laryngoscopy. Research regarding difficult mask ventilation combined with difficult laryngoscopy is extremely limited even though these two aspects of airway management are closely related. The aim of our study is to evaluate the accuracy of preoperative ultrasound assessment of neck anatomy in predicting difficult mask ventilation and difficult laryngoscopy in patients undergoing elective surgery with general anesthesia Primary objective: To correlate preoperative upper airway ultrasound measurements to predict difficult mask ventilation and difficult laryngoscopy Secondary objectives: · To correlate findings of upper airway ultrasound measurements with body mass index (BMI) in predicting difficult mask ventilation and difficult laryngoscopy · To compare upper airway ultrasound measurements with conventional clinical assessments in predicting difficult mask ventilation and difficult laryngoscopy · To evaluate the demographic variables associated with difficult mask ventilation and difficult laryngoscopy Methods: This will be a prospective observational study conducted on 114 adult patients of either sex, between 18-65 years undergoing elective surgeries under general anesthesia with muscle relaxation and endotracheal intubation in various surgical specialties at All India Institute of Medical Sciences, Bhopal, India. Institutional human ethics committee approval will be obtained before starting the trial. In the preoperative area, upper airway ultrasound parameters namely, distance from skin to hyoid bone (DSHB), distance from skin to thyroid isthmus (DSTI), thickness of base of the tongue (TBT) will be noted. Then the patient will be shifted inside the operation theatre and given general anesthesia. Han scale grading and Cormack-Lahane grading will be noted during mask ventilation and laryngoscopy respectively. The results will be analyzed to assess upper airway ultrasound measurements to predict difficult mask ventilation and difficult laryngoscopy. Outcome parameters: Ultrasound based airway parameters: 1. Distance from skin to hyoid bone (DSHB) 2. Distance from skin to thyroid isthmus (DSTI) 3. Thickness of base of the tongue (TBT) Conventional clinical assessment: 1. Modified Mallampati grading (MMP) 2. Upper lip bite test Body mass index (BMI) and other demographic variables like age, gender Han scale grading Cormack-Lahane grading |