| CTRI Number |
CTRI/2024/09/073970 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to compare use of ultrasonography VS carbondioxide monitoring and breath sounds to confirm tube position in trachea. |
|
Scientific Title of Study
|
A Prospective comparative study of Ultrasonography (USG) tool Vs Capnography and chest auscultation to confirm Endotracheal intubation performed by Anaesthesia residents |
| 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 Rochana Bakshi |
| Designation |
Professor |
| Affiliation |
D Y PATIL HOSPITAL |
| Address |
Department of Anaesthesia 2nd Floor A Block Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5, Nerul Navi Mumbai Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9323272151 |
| Fax |
|
| Email |
drrochana@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rochana Bakshi |
| Designation |
Professor |
| Affiliation |
D Y PATIL HOSPITAL |
| Address |
Department of Anaesthesia 2nd Floor A Block Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5, Nerul Navi Mumbai Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9323272151 |
| Fax |
|
| Email |
drrochana@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dheeraj |
| Designation |
Junior Resident |
| Affiliation |
D Y PATIL HOSPITAL |
| Address |
Department of Anaesthesia 2nd Floor A Block, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
8885430000 |
| Fax |
|
| Email |
cdd.1905@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y PATIL Hospital
Ayyappa Temple Rd, Dr D Y Patil Vidyanagar,Sector 5,
Nerul,Navi Mumbai,
Maharashtra,400706 |
|
|
Primary Sponsor
|
| Name |
D Y PATIL HOSPITAL |
| Address |
Department of Anaesthesia 2nd Floor A Block Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra 400706 |
| 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 Rochana Bakshi |
D Y PATIL HOSPITAL |
Department of Anaesthesia,second floor A block
D Y PATIL Hospital,
Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra 400706
Thane
MAHARASHTRA |
9323272151
drrochana@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee for Biomedical and Health research (IECBH) of Dr D Y Patil Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Capnography and Chest Auscultation. |
Confirming endotracheal intubation by 6 consecutive ETCO2 wave patterns on capnography and bilateral air entry on chest auscultation. |
| Intervention |
Ultrasonography tool |
Confirming endotracheal intubation using Ultrasonography tool by looking for reverberation artifact. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
MPC1&2
ASA1&2 |
|
| ExclusionCriteria |
| Details |
NON CONSENTING PATIENTS
PREGNANT PATIENTS
DIFFICULT AIRWAY
OBSTRUCTIVE SLEEP APNOEA
MORBID OBESITY
PEDIATRIC AGE GROUP |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine if Ultrasonography tool is a faster method of confirming correct placement of endotracheal tube compared to capnography and chest auscultation. |
At the time of laryngoscopy,after intubation,at the end of first capnography wave,sixth capnography wave,after chest auscultation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine if usg tool could guide the endotracheal tube towards the trachea if going towards oesophagus |
At the time of laryngoscopy,after intubation,at the end of first capnography wave,sixth capnography wave,after chest auscultation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
21/09/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study will be carried out on patients undergoing surgery under General Anaesthesia(GA)and who require Endotracheal intubation a through pre operation check up will be done prior and on the day of surgery after confirming fasting patients will be taken to operation theatre after the patient enters the operation theatre routine monitors will be attached and patients will be pre oxygenated for 3 minutes and injection Propofol 2mg per kg of patients weight injection Fentanyl 2mcg per kg of patients weight and injection Atracurium 0.5mg per kg of patients weight as loading dose will be used to induce General Anaesthesia and Anaesthesia post graduate residents of first and second year of training will perform endotracheal intubation as the patient is undergoing laryngoscopy the time at which the scope is introduced into the oral cavity the time starts and as the tube enters the vocal cords a Reverberation artifact is seen and this is a sign of endotracheal intubation seen under the guidance of ultrasonography the time of artifact is noted and once the tube is fixed the patient is ventilated through the ventilator where we see the Etco2 readings as wave patterns and as the first wave pattern ends time is noted and six waves patterns are considered as a confirmatory sign for a successful endotracheal intubation and the time at the end of sixth reading of Etco2 is noted and the bilateral chest auscultation and bilaterally equal air entry concludes another confirmatory sign of successful endotracheal intubation and the time of confirmatory auscultatory sign is noted and time differences are noted and the ultrasonography guided successful endotracheal intubation is proved to be faster than conventional methods
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