| CTRI Number |
CTRI/2018/05/013586 [Registered on: 01/05/2018] Trial Registered Prospectively |
| Last Modified On: |
25/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
comparison of two techniques , lung ultrasound and listening to air flow by stethoscope, to confirm flow of air in both lungs at two volumes of lung ventilation in cardiac surgical patients |
|
Scientific Title of Study
|
comparison of lung ultrasound and auscultation after endotracheal intubation for confirmation of bilateral air entry at two different tidal volumes in cardiac surgical patients- A crossover study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
prabhat tewari |
| Designation |
Professor, Dept of Anaesthesiology , SGPGI |
| Affiliation |
SGPGI |
| Address |
Dept of Anaesthesiology, SGPGI, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9794393344 |
| Fax |
|
| Email |
ptewari123@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
prabhat tewari |
| Designation |
Professor, Dept of Anaesthesiology , SGPGI |
| Affiliation |
SGPGI |
| Address |
Dept of Anaesthesiology, SGPGI, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9794393344 |
| Fax |
|
| Email |
ptewari123@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
prabhat tewari |
| Designation |
Professor, Dept of Anaesthesiology , SGPGI |
| Affiliation |
SGPGI |
| Address |
Dept of Anaesthesiology, SGPGI, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9794393344 |
| Fax |
|
| Email |
ptewari123@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES, TELIBAGH, RAE BAREILLY ROAD, LUCKNOW 226014 |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Post graduate institute of medical sciences |
| Address |
Telibagh, Rae Bareilly road, Lucknow, 226014 |
| 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 Prabhat Tewari |
OT 1- Cardiovascular and thoracic surgery OT, SGPGIMS MAIN OT COMPLEX |
main ot complex,near department of anesthesiology, sgpgi campus, telibagh, lucknow
Lucknow
UTTAR PRADESH |
9794393344
ptewari123@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, SGPGI LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Cardiac surgical patients, (1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing elective cardiac surgical procedure under general anaesthesia with endotracheal intubation
Informed written consent
|
|
| ExclusionCriteria |
| Details |
Modified Mallampati class 3 or 4
Morbid obesity
patients with critical preoperative state (ventilated, cardiogenic shock, inotropic support, intra-aortic balloon pump |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of each method, sensitivity and specificity |
time taken for each technique |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| faster and feasible technique |
before induction of anaesthesia anaesthetist 2 and 3 auscultate and do ultrasound lung then immediately after intubation and confirmation of adequate capnograph by intubating anaesthetist 1, no. 2 & 3 auscultate and do USG at 7ml/kg or 10 ml/kg TV (randomised) all the 3 results (before induction and at 2 TV)are marked on a paper and time taken to auscultate and USG at both TV is also noted by OT technician |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/05/2018 |
| Date of Study Completion (India) |
25/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/03/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is being started in cardiac surgical patients in SGPGI LUCKNOW where two techniques are being compared ie lung ultrasound and auscultation for confirmation of bilateral air entry in cardiac surgical patients at two different tidal volumes , for rapidity, sensitivity and specificity of each technique. |