| CTRI Number |
CTRI/2024/06/069109 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective non randomized observer blinded study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of tube placement in windpipe confirmation by ultrasound and using stethoscope |
|
Scientific Title of Study
|
Comparison of point of care ultrasound and auscultation in determining the placement of endotracheal tube in intubated patients in intensive care unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anish Kumar singh |
| Designation |
Associate Professor at department of Anesthesia and critical care |
| Affiliation |
|
| Address |
Department of Anaesthesia and critical care
Pandit Bhagwat Dayal Sharma postgraduate institute of medical sciences rohtak Haryana -124001
Rohtak
HARYANA
124001
India |
| Phone |
9990281753 |
| Fax |
|
| Email |
anishsingh79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahima saxena |
| Designation |
Post graduate resident |
| Affiliation |
Pandit Bhagwat Dayal Sharma post graduate institute of medical sciences |
| Address |
Department of Anaesthesia and critical care
Pandit Bhagwat Dayal Sharma postgraduate institute of medical sciences
Rohtak
HARYANA
124001
India |
| Phone |
9634232965 |
| Fax |
|
| Email |
mahisaxena023@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahima saxena |
| Designation |
Post graduate resident |
| Affiliation |
Pandit Bhagwat Dayal Sharma post graduate institute of medical sciences |
| Address |
Department of Anaesthesia and critical care
Pandit Bhagwat Dayal Sharma postgraduate institute of medical sciences
Rohtak
HARYANA
124001
India |
| Phone |
9634232965 |
| Fax |
|
| Email |
mahisaxena023@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Bhagwat Dayal Sharma postgraduate institute of medical sciences-Rohtak , Haryana-124001
Department of Anesthesia and critical care |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and critical care |
| Address |
Pandit Bhagwat Dayal Sharma postgraduate institute of medical sciences Rohtak Haryana -124001
Department of Anesthesia and critical care |
| Type of Sponsor |
Government medical college |
|
|
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 saxena |
Department of Anaesthesia and critical care |
Pandit Bhagwat Dayal Sharma postgraduate institute of medical sciences rohtak , Haryana 124001
Department of anaesthesia and critical care
Rohtak
HARYANA |
9634232965
mahisaxena023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Iomedical research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evaluation of endotracheal tube placement by auscultation,ultrasonography and fiberoptic bronchoscopy in each study patients
|
First anaesthetist will confirm the placement of endotracheal tube using auscultation in second to fifth intercostal spaces in mid clavicular and mid axillary lines bilaterally
Second anaesthetist will confirm the placement of endotracheal tube using point of care ultrasound and kind sliding sign will be elicited in third to fifth intercostal spaces in mid clavicular and mid axillary lines bilaterally
Third anaesthetist will confirm the placement of endotracheal tube using fiberoptic bronchoscopy after doing proper suctioning and providing adequate sedation to the patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex
More than 18 years of age
ASAI-III
intubated patients shifted to ICU and intubated outside the ICU in emergency department ward or other hospital |
|
| ExclusionCriteria |
| Details |
Refusal to consent
Lung pathology ( pneumothorax,pleural effusion,emphysema)
Pregnancy
Difficult airway
Hemodynamic instability
Oxygen requirement more than 50%, high positive end expiratory pressure more than 8 cm H20 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of point of care ultrasonography and auscultation for determining the correct endotracheal tube placement in comparison to fiberoptic bronchoscopy |
At the time of admission to ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of endobronchial tube placement of ETT in ICU
Time taken for auscultation,ultrasonography and fiberoptic bronchoscopy to determine ETT placement |
At the time of admission to ICU |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
24/06/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Four anaesthetists will be involved in the study. One of these will be recording the observations during the procedure.The three anaesthetists who will perform the examination will be kept blinded to the findings of each other. First anaesthetist will confirm the placement the placement of ETT using auscultation Second anaesthetist will determine the placement of ETT using POCUS Third anaesthetist will confirm the placement using fiberoptic bronchoscopy |