| CTRI Number |
CTRI/2024/05/068209 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Transverse versus longitudinal view ultrasonography for correct endotracheal tube placement ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Is Longitudinal view real time ultrasonography equivalent to transverse view in confirming correct placement of endotracheal tube for intubating patients? |
|
Scientific Title of Study
|
Transverse versus longitudinal view ultrasonography for correct endotracheal tube placement in adults in intensive care unit: a randomized controlled study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Kumar |
| Designation |
Consultant |
| Affiliation |
Sir Ganga Ram hospital |
| Address |
Department of Critical Care Medicine
Sir Ganga Ram Hospital, New Delhi-110060, INDIA
New Delhi
DELHI
110060
India |
| Phone |
9560483158 |
| Fax |
|
| Email |
rahul_krajput@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Gautam |
| Designation |
Drnb critical care medicine trainee |
| Affiliation |
|
| Address |
4th floor
SSRB Building
Institute of Critical Care Medicine
Sir Ganga Ram Hospital, New Delhi-110060, INDIA
New Delhi
DELHI
110060
India |
| Phone |
7289948481 |
| Fax |
|
| Email |
neerajgautam11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Gautam |
| Designation |
Drnb critical care medicine trainee |
| Affiliation |
|
| Address |
4th floor SSRB Building
Institute of Critical Care Medicine
Sir Ganga Ram Hospital, New Delhi-110060, INDIA
New Delhi
DELHI
110060
India |
| Phone |
7289948481 |
| Fax |
|
| Email |
neerajgautam11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Critical Care Medicine Sir Ganga Ram Hospital, New Delhi-110060, INDIA |
|
|
Primary Sponsor
|
| Name |
Department of Critical Care Medicine Sir Ganga Ram Hospital, New Delhi-110060, INDIA |
| Address |
Department of Critical Care Medicine Sir Ganga Ram Hospital, New Delhi-110060, INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Neeraj Gautam |
Sir Ganga Ram Hospital |
Intensive care unit, 4th floor SSRB Building
Institute of Critical Care Medicine Sir Ganga Ram Hospital, New Delhi-110060, INDIA
New Delhi
DELHI |
7289948481
neerajgautam11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Compare the efficacy of real-time ultrasonography in transverse versus longitudinal views for confirming endotracheal intubation, using sustained waveform capnography and chest auscultation as standard techniques. |
To compare the efficacy of endotracheal intubation in adults using Longitudinal view and Transverse view real-time ultrasonography in patients admitted in an adult intensive care unit. Efficacy will be assessed by correct placement of endotracheal tube, number of attempts needed for endotracheal intubation, failed intubation after two attempts and time taken to confirm endotracheal intubation with combination of sustained waveform capnography and chest auscultation as standard technique |
| Intervention |
Correct endotracheal tube placement in adults in intensive care unit using sustained waveform capnography and chest auscultation as standard techniques. |
Endotracheal intubation is a high risk procedure . Rapidly confirming endotracheal intubation is crucial as is detection of esophageal intubation to prevent adverse effect |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
pateints with Age more than 18 yrs. both male and female patients will be included in the study |
|
| ExclusionCriteria |
| Details |
Presence neck mass, Priorly tracheostomized patients , Cervical spine injury patients,History of neck surgery in past,Consent not given for endotracheal intubation and videography.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Transverse versus Longitudinal view ultrasonography for correct endotracheal tube placement in adults in intensive care unit.
Efficacy will be assessed by correct placement of endotracheal tube, number of attempts needed for endotracheal intubation, failed intubation after two attempts and time taken to confirm endotracheal intubation with combination of sustained waveform capnography and chest auscultation as standard technique |
Successful endotracheal intubation at 2 minutes.
Number of attempts taken for endotracheal intubation within 2 minutes.
First pass success for endotracheal intubation within 2 minutes.
Time for ultrasound-based confirmation of endotracheal intubation within 2 minutes.
Time for capnography confirmation of endotracheal intubation within 2 minutes.
Time for clinical confirmation by chest auscultation within 2 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="304"
Sample Size from India="304"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
endotracheal intubation is a high risk procedure, often performed as emergency leading to higher incidence of osophageal intubation.Rapidly confirming endotracheal intubation is crucial,as is early detection of esophageal intubation,to prevent adverse effects. Various methods for confirming endotracheal intubation exist,such as sustained waveform capnography,chest auscultaion,chest xray,bronchoscopy,and real time ultrasonography. The American heart association recommends combining continuos sustained waveform capnography with chest auscultation to confirm endotracheal tube placement.nevertheless this requires delivering 6-7 mechanical breaths,which can pose risks in patients if the endotracheal intubation without ventilating the patient.Real time ultrasonography for airway management has become increasingly popular over the past decade due to its accessibility , painlessness affordabilty reproducibilty and safety.In our Study we aim to compare the efficacy of real time ultrasonography in transverse versus longitudinal views for confirming endotracheal intubation using sustained capnography and chest auscultation.
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