| CTRI Number |
CTRI/2025/06/088653 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of High flow nasal cannula versus standard oxygen therapy assisted sedation in ERCP |
|
Scientific Title of Study
|
Comparison of high flow nasal cannula versus standard oxygen therapy assisted sedation during endoscopic retrograde cholangiopancreatography |
| 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 D R Famara |
| Designation |
PG student |
| Affiliation |
Army Hospital Research and Referral, Delhi |
| Address |
Dept of anesthesiology and critical care AHRR, Delhi
South West
DELHI
110010
India |
| Phone |
9410577771 |
| Fax |
|
| Email |
famara2853@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Col (Dr) Josemine Davis |
| Designation |
Professor and Guide |
| Affiliation |
Army Hospital Research and Referral, Delhi |
| Address |
Department of anesthesiology and critical care, 2nd floor, AHRR, Delhi-110010, India
Department of Anesthesiology and critical care, 2nd floor, AHRR Delhi-110010, India
South West
DELHI
110010
India |
| Phone |
9764623542 |
| Fax |
|
| Email |
jose2mine@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D R Famara |
| Designation |
PG student |
| Affiliation |
Army Hospital Research and Referral, Delhi |
| Address |
Dept of anesthesiology and critical care AHRR, Delhi
South West
DELHI
110010
India |
| Phone |
9410577771 |
| Fax |
|
| Email |
famara2853@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and critical care, AHRR Delhi-10 , India |
|
|
Primary Sponsor
|
| Name |
Army hospital Research and Referral |
| Address |
Army hospital R and R, Department of Anesthesiology and Critical care, Delhi 110010 |
| 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 D R Famara |
Army Hospital Research and Referral |
Department of anesthesiology and critical care ,AHRR DELHI
South West
DELHI |
9410577771
famara2853@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| intitutional ethics committee, Army Hospital R and R Delhi |
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
|
| Type |
Name |
Details |
| Comparator Agent |
High flow nasal cannula |
Incidence of hypoxemia spo2 less than 95% for 10seconds and severe hypoxemia spo2 less than 90% for 10 seconds during procedural time ,procedural duration start from insertion of Endoscope to removal of Endoscope and Hypoxemia and severe hypoxemia duration for 10seconds and total duration of procedure will be around 30min to 60min |
| Comparator Agent |
Standard oxygen therapy |
Incidence of hypoxemia spo2 less than 95% for 10seconds and severe hypoxemia spo2 less than 90% for 10 seconds during procedural time, Procedure duration start from insertion of Endoscope to removal of endoscope and hypoxemia and severe hypoxemia duration for 10 seconds and total duration of procedure will be around 30min to 6omin |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical status class I-III , schedule for elective ERCP under sedation |
|
| ExclusionCriteria |
| Details |
Age less than 18yrs or more than 70yrs with coexisting respiratory, cardiac illness, dementia, cognitive disorder, pregnancy, allergic to Propofol and Fentanyl, anticipated difficult intubation , tracheostomized, emergency ERCP. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypoxemia spo2 less than 95% for 10 seconds and severe hypoxemia spo2 less than 90% for 10seconds during procedural time |
At baseline and T1,5,10,15,20,30,45,60,75(minutes) and PACU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total Propofol consumption |
At end of procedure in PACU |
| Need of assisted ventilation |
During procedure in between when required & requirement episodes will be recorded |
| Airway manipulation |
During procedure & episodes will be recorded |
| Endoscopist & Patient satisfaction |
At end of Procedure |
| Total procedural duration |
At end of procedure |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
24/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/06/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
ERCP is a common diagnostic and therapeutic procedure often require sedation. The incidence of hypoxemia noted during ERCP under sedation presumably because lengthy procedure, endoscopist share common airway and is performed in semiprone or pronr postion. The choice of oxygen method during sedation play a crucial role in safety and outcomes as well as patient comfort.
Use of HFNC is widened to critical care and day care procedures in non operating room anesthesia settings under sedation. Very few similar studies conducted in Indian population . |