| CTRI Number |
CTRI/2018/03/012409 [Registered on: 07/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
01/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Other |
|
Public Title of Study
|
Using ultrasound of the windpipe for early confirmation of tube placement in patients receiving general anaesthesia and comparison of its results with end-tidal capnography which is the gold standard |
|
Scientific Title of Study
|
Airway Ultrasonography and End-tidal Capnography for early confirmation of endotracheal tube placement : 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 |
Mahima Nayyar |
| Designation |
DNB Resident |
| Affiliation |
BLK Superspeciality Hospital |
| Address |
OT complex, 2nd floor,
BLK Superspeciality Hospital
OT complex, 2nd floor,
BLK Superspeciality Hospital
New Delhi
DELHI
110005
India |
| Phone |
8800386681 |
| Fax |
|
| Email |
patmahimanayyar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sabih Ahmad |
| Designation |
Senior Consultant |
| Affiliation |
BLK Superspeciality Hospital |
| Address |
OT complex, 2nd floor,
BLK Superspeciality Hospital
Pusa Road
OT complex, 2nd floor,
BLK Superspeciality Hospital
Pusa Road
New Delhi
DELHI
110005
India |
| Phone |
9650609347 |
| Fax |
|
| Email |
sabih123ahmad@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mahima Nayyar |
| Designation |
DNB Resident |
| Affiliation |
BLK Superspeciality Hospital |
| Address |
OT complex, 2nd floor,
BLK Superspeciality Hospital
OT complex, 2nd floor,
BLK Superspeciality Hospital
DELHI
110005
India |
| Phone |
8800386681 |
| Fax |
|
| Email |
patmahimanayyar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.B.L.Kapur Superspeciality Hospital |
|
|
Primary Sponsor
|
| Name |
Mahima Nayyar |
| Address |
OT Complex, 2nd floor,
BLK Superspeciality Hospital,
Pusa Road, New Delhi-110005. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Mahima Nayyar |
Dr.B.L.Kapur Superspeciality Hospital |
Ot Complex, 2nd floor,
Dr.B.L.Kapur Superspeciality Hospital
Pusa Road
New Delhi-110005
New Delhi
DELHI |
8800386681
patmahimanayyar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.B.L.Kapur Memorial Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
for Elective surgeries, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Modified Mallampati grading less than 3
Elective surgeries
Mouth opening > 3 cm |
|
| ExclusionCriteria |
| Details |
Neck tumours/visible neck swelling
History of neck operation/trauma/radiation
Limited neck extention
Neck diameter >40 cm
Emergency surgeries
High risk of aspiration
Pregnancy
Anticipated difficult airway
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Confirmation of endotracheal tube in trachea via ultrasonography as an alternative to the gold standard, capnography. |
Measure time taken for confirmation of endotracheal tube by waveform capnography and airway ultrasonography |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ultrasound help in detection of correct placement of endotracheal tube even prior to capnography which is the gold standard |
To compare sensitivity and specificity for airway ultrasonography and capnography |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/01/2018 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is important to confirm proper placement of endotracheal(ET) tube as inadvertent esophageal intubation is associated with catastrophic consequences. Quantitative waveform capnography is currently the gold standard and most sensitive method for confirmation of ET tube.However it has some limitations like its accuracy may be compromised in patients suffering from pulmonary embolism or those in cardiac arrest. Also respiration must be maintained for several breaths to accurately confirm the ET tube placement and this can lead to fatal regurgitation and aspiration in full stomach patients being ventilated with a misplaced esophageal tube. Thirdly capnography may provide false negative results in case of severe airway obstruction or use of epinephrine. Ultrasound guided confirmation of correct ET tube placement has been described in adults with high sensitivity and specificity in both controlled operating room conditions and emergency or ICU settings.Ultrasound is a novel tool, provides real time view and can be performed quickly. Furthermore it is independent of pulmonary blood flow and does not require lung ventilation. We plan to do prospective observational study to compare upper airway(tracheal) USG with reference to capnography( the gold standard) for early confirmation of ET tube placement. |