| CTRI Number |
CTRI/2023/03/050743 [Registered on: 15/03/2023] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative observation |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of end tidal capnography, chest auscultation and upper airway ultrasonography for the rapid confirmation of endotracheal tube placement by trainees in patients requiring intubation for general anaesthesia |
|
Scientific Title of Study
|
Comparison of End Tidal Capnography, Chest Auscultation And Upper Airway Ultrasonography For The Rapid Confirmation Of Endotracheal Tube Placement By Trainees In patients Requiring Intubation For General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vallikanna Subramanian |
| Designation |
Post graduate |
| Affiliation |
Kasturba medical college, Mangalore |
| Address |
Department of anaesthesiology, KMC Mangalore , Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9585532498 |
| Fax |
|
| Email |
vallikannasubramanian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Julie C R Misquith |
| Designation |
Associate professor |
| Affiliation |
Kasturba medical college, Mangalore |
| Address |
Department of anaesthesiology, KMC Mangalore , Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9945598911 |
| Fax |
|
| Email |
julie.misquith@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vallikanna Subramanian |
| Designation |
Post graduate |
| Affiliation |
Kasturba medical college, Mangalore |
| Address |
Department of anaesthesiology, KMC Mangalore , Karnataka
KARNATAKA
575001
India |
| Phone |
9585532498 |
| Fax |
|
| Email |
vallikannasubramanian@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Vallikanna Subramanian |
| Address |
#210 S , falnir ladies pg hostel, falnir, Karnataka |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VALLIKANNA Subramanian |
Kasturba medical college |
Department of Anaesthesiology, KMCH Attavar, mangalore, Karnataka
Dakshina Kannada
KARNATAKA |
9585532498
vallikannasubramanian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Kasturba medical college, Mangalore |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients undergoing elective orotracheal intubation
|
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA1,2,3
Modified mallampatti class 1 and 2
BMI < 30 kg/ m2
Posted for elective surgeries requiring general anaesthesia with orotracheal intubation |
|
| ExclusionCriteria |
| Details |
Modified mallampatti class 3 and 4
BMI>30 kg/ m2
Thyromental distance < 6.5cm
Negative upper lip bite test
Restricted neck movement ( flexion < 25 degrees, extension < 85 degrees )
Previous history of difficult intubation |
|
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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 |
Time taken for detection of endotracheal tube placement by each method
Hemodynamic parameters - HE, SBP, DBP, MAP, SPO2 |
4 weeks : 09/04/2023 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of intubation attempts
Number of esophageal intubation
Incidence of desaturation |
8 weeks |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
22/03/2023 |
| 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="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
Patients undergoing elective orotracheal intubation are included in the study to compare the time taken by each method of endotracheal tube placement confirmation like capnography, chest auscultation and ultrasonography by First year anesthesia postgraduate trainees
|