| CTRI Number |
CTRI/2019/04/018398 [Registered on: 02/04/2019] Trial Registered Prospectively |
| Last Modified On: |
05/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Using ultrasonography,we assess the tracheal tube placement under general anaesthesia |
|
Scientific Title of Study
|
Evaluation of point of care ultrasonography for assessment of tracheal tube placement under general anaesthesia: an observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKHIL PIYUSH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
OT COMPLEX, 1ST FLOOR
IGIMS,PATNA 800014
BIHAR
Patna
BIHAR
800014
India |
| Phone |
8826974799 |
| Fax |
|
| Email |
apiyush2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KH Raghwendra |
| Designation |
Professor |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
OT COMPLEX, 1ST FLOOR
IGIMS,PATNA 800014
BIHAR
Patna
BIHAR
800014
India |
| Phone |
9473191811 |
| Fax |
|
| Email |
dr.khraghwendra@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
AKHIL PIYUSH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
OT COMPLEX, 1ST FLOOR
IGIMS,PATNA 800014
BIHAR
Patna
BIHAR
800014
India |
| Phone |
8826974799 |
| Fax |
|
| Email |
apiyush2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept.of Anaesthesiology and critical care,Indira Gandhi Institute of Medical Sciences,Patna-800014 |
|
|
Primary Sponsor
|
| Name |
IGIMS |
| Address |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES PATNA |
| 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 |
| Dr AKHIL PIYUSH |
IGIMS |
Department of Anaesthesiology,
OT Complex,1st floor
Patna
BIHAR |
8826974799
apiyush2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,SHEIKHPURA, PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
Mallampati score 1 & 2
Patient assigned for general anaesthesia with endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Patient’s refusal to participate
Patients of Mallampati score class III and IV
Patients with severe neck trauma, neck mass
Patients with scars of previous neck surgery
Patients with limited neck extension
Patients with abnormal airway anatomy and obesity.
Patients need emergency intubation or with high risk of aspiration and severe
cardiac, pulmonary, hepatic, or renal disease were excluded from the
study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prediction of successful placement of tracheal tube compared to conventional method (auscultation and wave capnography)
Time taken till confirming the diagnosis
|
0 to 5 minutes post intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken till confirming the diagnosis |
0 to 5 minutes post intubation |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
09/04/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Plan to publish the findings in due time |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients will recieve same anaesthetic protocols including premedication using induction of anaesthesia by Fentanyl 2 mcg/kg and Propofol 2 mg/kg followed by Atracurium 0.5 mg /kg to facilitate tracheal intubation. Upper airway usg will be performed using 6-13 MHz linear ultrasound transducer placed transversely on neck anteriorly and supeior to suprasternal notch before intubation. Visualisation of tracheal tube in longitudinal and transverse views. The obtained results will be compared to positive result of quantitative conventional method i.e waveform capnography and auscultation. Time used by usg to assure tracheal intubation will be determined. |