| CTRI Number |
CTRI/2014/08/004867 [Registered on: 11/08/2014] Trial Registered Prospectively |
| Last Modified On: |
08/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
diagnostic test |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
detecting position of breathing tube in wind pipe using sonography |
|
Scientific Title of Study
|
ULTRASOUND CONFIRMATION OF ENDOTRACHEAL TUBE PLACEMENT WITH THE SALINE FILLED CUFF TECHNIQUE AND COMPARISION OF DEPTH OF INSERTION WITH CHEST X RAY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijaya Patil |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Ruby House, Second Floor, L.J.Road,Mahim, Mumbai
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, E.Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400016
India |
| Phone |
912224451118 |
| Fax |
|
| Email |
vijayappatil@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijaya Patil |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Ruby House, Second Floor, L.J.Road,Mahim, Mumbai
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, E.Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400016
India |
| Phone |
912224451118 |
| Fax |
|
| Email |
vijayappatil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijaya Patil |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Ruby House, Second Floor, L.J.Road,Mahim, Mumbai
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, E.Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400016
India |
| Phone |
912224451118 |
| Fax |
|
| Email |
vijayappatil@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Vijaya Patil |
Intensive care Unit, Tata Memorial Hospital |
E.Borges Marg, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
022-24177048
vijayappatil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients requiring intubation in ICU, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
all consenting patients requiring intubation in ICU will be included |
|
| ExclusionCriteria |
| Details |
refusal of consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. visualisation of endotracheal placement of tube during intubation
2. visualisation of saline filled cuff of endotracheal tube |
during intubation and immediately after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| determining position of saline filled cuff in ultrasonography and comparision with X ray position of tip of endotracheal tube |
within 2 hours after intubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "89"
Final Enrollment numbers achieved (India)="89" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2014 |
| Date of Study Completion (India) |
23/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
23/03/2017 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Utility of ultrasound of upper airway for confirmation of
endotracheal intubation and confirmation of the endotracheal
tube position in the intensive care unit patients
Vijaya Patil1, Shilpushp Bhosale, Atul Kulkarni1, Natesh Prabu, Vikas Bhagat, Harish Chaudhary,Suhail Sarawar, Amit Narkhede, Jigeshu Divatia.J Emerg Crit Care Med 2019;3:15 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
In this prospective observational study, we found that airway ultrasonography is useful for confirmation of tracheal intubation with high sensitivity (96.55%) In our study the airway ultrasonography was able to confirm ETT placement with 96% sensitivity and 100% specificity. Loss of snow storm sign was identified in all patients except 3 patients in whom the tube placement was confirmed by capnography. The saline filled cuff was visualized in all patients and was 100% specific for correct depth of ETT in the trachea when compared with chest X-ray. In 2 patients, we could detect esophageal intubation in real time by identifying the double track sign and absence of loss of snow storm sign and hence may have prevented esophageal intubations. |