| CTRI Number |
CTRI/2020/08/027496 [Registered on: 31/08/2020] Trial Registered Prospectively |
| Last Modified On: |
28/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess difficulty prior using ultrasound in holding the mask effectively at the start of anaesthesia |
|
Scientific Title of Study
|
TONGUE BASE THICKNESS USING ULTRASOUND IN PREDICTING DIFFICULTY IN MASK VENTILATION: A PROSPECTIVE STUDY
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Victoria hospital , Department of Anaesthesiology, Operation theater complex, KR Road
Victoria hospital , Department of Anaesthesiology, Operation theater complex, KR Road
Bangalore
KARNATAKA
560002
India |
| Phone |
9972454989 |
| Fax |
|
| Email |
swathisaggi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Victoria hospital , Department of Anaesthesiology, Operation theater complex, KR Road
Victoria hospital , Department of Anaesthesiology, Operation theater complex, KR Road
Bangalore
KARNATAKA
560002
India |
| Phone |
9972454989 |
| Fax |
|
| Email |
swathisaggi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Victoria hospital , Department of Anaesthesiology, Operation theater complex, KR Road
Victoria hospital , Department of Anaesthesiology, Operation theater complex, KR Road
Bangalore
KARNATAKA
560002
India |
| Phone |
9972454989 |
| Fax |
|
| Email |
swathisaggi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Bangalore medical college and research institute |
| Address |
Bangalore medical college and research institute, Department of Anaesthesiology, OT complex, Fort road, Bangalore-560002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Swathi N |
Bangalore Medical College and Research Institute |
Operation theater complex, Fort road, Bangalore-560002
Bangalore
KARNATAKA |
9972454989
swathisaggi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMCRI Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient who give written informed consent
2)ASA I and II
3)Patients with BMI 18-25 kg/m2
4)Age 18-50 yrs, either sex
5)Patients scheduled for elective surgeries under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1)Patient refusal
2)Patients undergoing regional anesthesia and those with contraindication of mask ventilation (i.e., emergency cases requiring a rapid sequence induction, planned awake intubation) will be excluded
3)Presence of upper airway anatomical deformity, trauma, or tumour, beard ;
4)Presence of identifiable difficult airway or difficult airway history that required the patient to be awake during tracheal intubation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease/ difficulty in mask ventilation |
During induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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)
|
02/09/2020 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All patients will undergo airway and ultrasonographic measurements in the pre-operative area. Difficulty in mask ventilation is assessed by a senior anaesthesiologist. Initial mask ventilation classification Grade 1- Could not attempt Grade 2- Easy mask Grade 3- Difficult mask ventilation requiring an oral airway or some other adjunct Grade 4- Very difficult mask ventilation requiring two practioners Grade 5- Unable to mask ventilate |