| CTRI Number |
CTRI/2020/01/022746 [Registered on: 14/01/2020] Trial Registered Prospectively |
| Last Modified On: |
08/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to assess usefulness of ultrasound and hearing for air sound over abdomen with stethescope to confirm correct placement of a tube passed from nose to stomach |
|
Scientific Title of Study
|
Usefulness of ultrasound in confirming correct placement of Ryles tube. A comparison with traditional method of auscultation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manu Sudevan |
| Designation |
Senior Resident |
| Affiliation |
Amrita Institute of Medical Sciences, |
| Address |
Department of Anaesthesia,
Amrita Institute of Medical Sciences,
Kochi,
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
7736282629 |
| Fax |
04842802020 |
| Email |
msudevan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Rajan |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia,
Amrita Institute of Medical Sciences,
Kochi,
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9447464652 |
| Fax |
04842802020 |
| Email |
suneil71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Rajan |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia,
Amrita Institute of Medical Sciences,
Kochi,
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9447464652 |
| Fax |
04842802020 |
| Email |
suneil71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
Ponekkara PO,
Kochi 682041 |
| 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 Sunil Rajan |
Amrita Institute of Medical Sciences |
Department of Anaesthesia,
Ponekkara PO,
Kochi
Ernakulam
KERALA |
9447464652
04842802020
suneil71@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients 0undergoing surgical procedures requiring Ryles tube. |
|
| ExclusionCriteria |
| Details |
1.Coagulaopathy
2.Midfacial and base of skull fractures
3.History of gastric by-pass
4.History of oesophageal strictures or alkali injury, upper GI bleed
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Usefulness of ultrasound versus auscultation in confirming correct Ryles tube placement. |
One minute after Ryles tube insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for confirmation with both techniques and ease of confirmation in overweight and obese patients. |
Soon after Ryles tube insertion time taken will be recorded.
Ease of confirmation will be noted once correct placement of Ryles tube is achieved |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 1 |
|
Date of First Enrollment (India)
|
15/01/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients who require Ryles tube insertion during surgery will be recruited. One group will form patients with a BMI of <25 and other group will be formed by patients with BMI >25. Accuracy of Ryles tube insertion and time taken for confirming correct placement by auscultation and by using ultrasound will be noted in both normal and overweight and obese patients. This study will be initiated as a pilot study with 10 patients in each group.
|