| CTRI Number |
CTRI/2023/06/054375 [Registered on: 23/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effect of different rates of oxygen flow through the nose during the video assessment of the biliary tract in sedated patients. |
|
Scientific Title of Study
|
Comparison of high flow nasal oxygen & conventional nasal oxygen during endoscopic retrograde cholangiopancreatography(ERCP) with sedation-a randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reetha Varghese |
| Designation |
Junior resident |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of Anaesthesia and Critical care
Jubilee Mission Medical College and Research Institute
East Fort
Thrissur
Thrissur
KERALA
680005
India |
| Phone |
9074245377 |
| Fax |
|
| Email |
reethavarghese1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Cherish Paul |
| Designation |
Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of Anaesthesia and Critical care
Jubilee Mission Medical College and Research Institute
East Fort
Thrissur
Thrissur
KERALA
680005
India |
| Phone |
8281295677 |
| Fax |
|
| Email |
cherishpaul@jmmc.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Cherish Paul |
| Designation |
Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of Anaesthesia and Critical care
Jubilee Mission Medical College and Research Institute
East Fort
Thrissur
Thrissur
KERALA
680005
India |
| Phone |
8281295677 |
| Fax |
|
| Email |
cherishpaul@jmmc.ac.in |
|
|
Source of Monetary or Material Support
|
| Jubilee mission medical college and research institute |
|
|
Primary Sponsor
|
| Name |
Jubilee Mission Medical College and Research Institute |
| Address |
Jubilee Mission Medical College and Research Institute,
East Fort, Thrissur, Kerala, 680005 |
| 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 Reetha Varghese |
Jubilee Mission Medical College and Research Institute |
Department of anaesthesia and critical care,
Gastroenterology endoscopy room,
Golden Jubilee building ,
East Fort
Thrissur
680005
Thrissur
KERALA |
9074245377
reethavarghese1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Jubilee mission medical college and research institute, Thrissur |
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 |
| Comparator Agent |
Conventional nasal oxygen |
Supplement oxygen using conventional nasal oxygen during endoscopic retrograde cholangiopancreatography |
| Intervention |
High flow nasal oxygen |
Supplement oxygen using high flow nasal oxygen during endoscopic retrograde cholangiopancreatography |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1,2,3
2.18 - 80 years of age.
3.Patients scheduled for ERCP
4.Patients with saturation >93% with/without oxygen. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the number of patients with saturation fall episodes(spo2 93%) during ERCP with sedation |
Time between insertion of endoscope to removal of endoscope at the end of the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the Mean duration of procedure between the two groups (time from insertion of endoscope to removal of endoscope at the end of the procedure).
2.To compare the number of patients who had procedural interruptions in terms of conversion to HFNO,LMAgastro ,endotracheal tube(ETT). |
Time between insertion of endoscope to removal of endoscope at the end of the procedure. |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
03/07/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oxygen supplementation is an important part in the safety of endoscopic retrograde cholangiopancreatography (ERCP). With our study we like to see whether supplementation of high flow oxygen has any benefit over the standard oxygen supplementation with regards to oxygen levels of the patients during endoscopic retrograde cholangiopancreatography. |