| CTRI Number |
CTRI/2020/12/029770 [Registered on: 14/12/2020] Trial Registered Prospectively |
| Last Modified On: |
11/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
The position of the tube which is placed into the windpipe is confirmed by watching movement of the membranes covering the lung surface by using ultrasound machine and also by listening to lung sounds by using stethoscope in patients undergoing surgery |
|
Scientific Title of Study
|
Confirmation of endotracheal intubation by ultrasonic sliding lung
sign and auscultation in normal and overweight surgical patients: A Comparative Study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Linju Varghese |
| Designation |
Junior Resident |
| Affiliation |
StJohns Medical College Hospital |
| Address |
StJohns Medical College Hospital Bangalore
anesthesia department
2nd floor OT
StJohns Medical College Hospital Bangalore
anesthesia department
2nd floor OT
Bangalore
KARNATAKA
560034
India |
| Phone |
7829438251 |
| Fax |
|
| Email |
diyamariachf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Moses Charles Dsouza |
| Designation |
Professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Department of Anaesthesia and Critical Care StJohns Medical College Hospital Bangalore
St Johns Medical College Hospital Bangalore
Bangalore
KARNATAKA
560079
India |
| Phone |
7829000524 |
| Fax |
|
| Email |
drmosescharlesdsouza@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Moses Charles Dsouza |
| Designation |
Professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Department of Anaesthesia and Critical Care StJohns Medical College Hospital Bangalore
St Johns Medical College Hospital Bangalore
Bangalore
KARNATAKA
560079
India |
| Phone |
7829000524 |
| Fax |
|
| Email |
drmosescharlesdsouza@gmail.com |
|
|
Source of Monetary or Material Support
|
| st. johns medical college hospital |
|
|
Primary Sponsor
|
| Name |
St Johns Medical College Hospital |
| Address |
St Johns Medical College Hospital Bangalore |
| Type of Sponsor |
Private 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 |
| Dr Moses Charles Dsouza |
St.Johns Medical College Hospital |
Anesthesia department,
2nd floor Operation Theater,
Surjapur Road, Koramangala,
Bangalore.
Bangalore
KARNATAKA |
7829000524
drmosescharlesdsouza@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||, (2) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A(BMI below 25) |
patients in this group will be intubated and the endotracheal tube placement will be confirmed by auscultation method and by using ultrasound lung sliding sign.(2-3 minutes) |
| Comparator Agent |
group B (BMI above 25) |
patients in this group will be intubated and the endotracheal tube placement will be confirmed by auscultation method and by using ultrasound lung sliding sign.(2-3 minutes) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 20-59yrs
2. Patients coming for elective surgeries under general anesthesia
3. ASA physical status I and II patients
4. Modified mallampati class 1 and 2 having no pulmonary co morbidities
|
|
| ExclusionCriteria |
| Details |
1. Patients with ASAIII and IV
2. Patients with anticipated difficult airway
3. Patients with significant cardiac and
pulmonary illness
4. Patients those require nasal intubation
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The time taken for confirming endotracheal tube placement using ultrasound vs auscultation method in normal and overweight patients |
2-3 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Accuracy of Ultrasonic lung sliding sign over auscultation method to rule out endobroncheal intubation |
5 minutes |
|
|
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)
|
20/12/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway management is a major responsibility of the anaesthesiologist. Difficulties with tracheal intubation significantly contribute to the morbidity and mortality assosiated with anaesthesia .Overweight and obese patients are predisposed to difficult airway and intubation in comparison to the non obese patients.According to WHO a person with BMI >25 is considered overweight and a person with BMI>30 is considered obese.increased risk of hypoxemia during the induction of anaesthesia in these patients could be compounded by an increased time required for insertion of the tracheal tube,besides reduction in functional residual capacity and compliance with an increase in airway resistance and pulmonary vascular resistance.most frequently used methods of confirmation of endotracheal intubation are auscultation of chest and end tidal carbon dioxide detection.obese patients usually yield confusing or misleading auscultatory findings as the sound waves have to traverse large amount of tissues which represent a significant barrier. Intercostals ultrasonographic view at the lung chest-wall interface, to and fro movement of the pleura synchronised with ventilation (lung sliding sign)is an accurate indicatorof endotracheal intubation,and hence can be used as an additional measure for confirming prooper tracheal placement of the endotracheal tube .In our study we aim to assess the time taken for confirming ETT placement using ultrasonic sliding lung sign vs. auscultation method in normal and obese surgical patients. |