| CTRI Number |
CTRI/2021/12/038505 [Registered on: 08/12/2021] Trial Registered Prospectively |
| Last Modified On: |
07/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the faster method to confirm insertion of tube into the trachea by comparing ultrasound scan of the trachea and carbon dioxide level in the exhaled breath |
|
Scientific Title of Study
|
Transtracheal ultrasonography and end-tidal capnography in the rapid confirmation of tube placement in patients requiring endotracheal intubation - 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 |
Dr Shruthi R |
| Designation |
Resident |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
Room no: 128,
Annexe 3,
St. Johns National Academy of Health Sciences,
Sarjapur Road,
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9741872128 |
| Fax |
|
| Email |
shruthi.95r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nischala Dixit C |
| Designation |
Associate Professor |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
2nd floor, OT complex,
Department of Anaesthesiology,
St Johns Medical College Hospital,
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9535148078 |
| Fax |
|
| Email |
drnischala01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Thomas T Vellapally |
| Designation |
Assistant Professor |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
2nd floor, OT complex,
Department of Anaesthesiology,
St Johns Medical College Hospital,
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9746717055 |
| Fax |
|
| Email |
tvthomas1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Shruthi R |
| Address |
Room no: 128,
Annexe 3,
St. Johns National Academy of Health Sciences,
Sarjapur Road,
Bangalore - 560034 |
| 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 Shruthi R |
St Johns Medical College Hospital |
Operation Theatre,
St Johns Medical College Hospital,
St. Johns National Academy of Health Sciences,
Sarjapur Road,
Bangalore - 560034
Bangalore
KARNATAKA |
9741872128
shruthi.95r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SJMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Consenting adult patients aged between 18 to 59 years with ASA grades 1 – 3 posted for elective surgery under general anaesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1) BMI greater than 30 kg/m2, 2) Patients with predictors of difficult intubation - Mallampati class IV, LEON score greater than/equal to 3, Patients with history of cervical spine disease, musculoskeletal disease, past history of neck surgery, 3) Patients with previous history of difficult intubation 4) Pregnant women
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To determine the mean time taken to confirm correct placement of endotracheal tube using both transtracheal ultrasonography and end-tidal capnography |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To make a comparative assessment between the above-mentioned techniques and determine the faster method for confirmation of endotracheal intubation |
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "112"
Final Enrollment numbers achieved (India)="112" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2021 |
| Date of Study Completion (India) |
31/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a hospital based observational study being performed to determine whether transtracheal ultrasonography or end-tidal capnography is the faster method to confirm proper placement of endotracheal tube during intubation. The mean time taken using the two above-mentioned techniques will be noted down and a comparative assessment will be made. The study participants will include consenting adult patients with ASA grades I - III, posted for elective surgery under general anaesthesia. |