| CTRI Number |
CTRI/2024/01/061007 [Registered on: 01/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare two methods of oxygenation,high flow nasal cannula versus conventional nasal cannula on oxygenation in patients who undergo Endoscopic Retrograde Cholangiopancreatography under sedation |
|
Scientific Title of Study
|
Comparision of the effect of high flow nasal cannula versus conevtional nasal cannula on oxygenation in patients undergoing Endoscopic Retrograde Cholangiopancreatography under sedation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi N Patil |
| Designation |
Post graduate |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, New Thargupet, Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9741753789 |
| Fax |
|
| Email |
rashupatil7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Sandhya |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Departmentof Anaesthesiology, Bangalore Medical College and Research Institute, New Thargupet, Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9972212417 |
| Fax |
|
| Email |
sandyaraghu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rashmi N Patil |
| Designation |
Post graduate |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, New Thargupet, Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9741753789 |
| Fax |
|
| Email |
rashupatil7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute,K.R road, fort, New thargupet, Bangalore -560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore medical college and research institute |
| Address |
Bangalore medical college and research institute, K.R.Road , fort, New thargupet, Bangalore 560002 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRashmi N Patil |
BMCRI Super Speciality Hospital |
BMCRI Super Speciality Hospital, Mysore Rd, near City Market, New Tharagupet, Bengaluru, Karnataka 560002 Bangalore KARNATAKA |
9741753789
rashupatil7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committe of Bangalore Medical College and Research Institute |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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 cannula |
This study compares low flow nasal cannula on oxygenation in another group of patients on oxygenation in patients undergoing endoscopic retrograde cholangiopancreatography under sedation for 2 hours |
| Intervention |
High flow nasal cannula |
This study compares the effect of high flow nasal cannula in one group versus low flow nasal cannula on oxygenation in patients undergoing endoscopic retrograde cholangiopancreatography under sedation for 2 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give informed written consent.
Patients belonging to American Society of Anesthesiologist class 1,2 and 3.
Patients scheduled to undergo endoscopic retrograde cholangiopancreatography
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give informed written consent
2. Patients with anticipated difficult airway and known previous difficult intubation
3. Patients with severe cardiac disorders, respiratory disorders and renal disorders that necessitate general anesthesia with endotracheal tube
4. Patients with increased risk of aspiration
5. Patients undergoing emergency procedures
6. Tracheostomized patients
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| number of episodes of desaturation ,Spo2 90% during endoscopic retrograde cholangiopancreatography under sedation |
2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)Number of events of hypoxia, defined as desaturation < 90%. The average number of events during the procedure will be compared between group A and B.
b)Lowest recorded SpO2% during the procedure. The mean values during the procedure will be compared between group A and B.
c)Heart rate
d)Blood pressure.
|
Until the ERCP procedure is complete |
|
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Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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 2 |
|
Date of First Enrollment (India)
|
10/01/2024 |
| 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="0" 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 - NO
|
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Brief Summary
|
ERCP (Endoscopic Retrograde Cholangiopancreatography) is a minimally invasive surgical procedure routinely used in the management of pancreatic and biliary disorders that require monitored anesthesia care to provide sedation and analgesia. ERCP is usually done in prone or lateral position which further complicates airway management. Sedation can range from moderate to deep sedation, including General anesthesia.Intravenous sedation could depress the respiration, increase the risk of upper airway obstruction by relaxation of respiratory muscles, hypoxia and aspiration. Hypoxemia further increases periprocedural myocardial infarction,arrythmias and cerebral hypoxia.Usually, patients with complex co-morbidities:Obstructive sleep apnea syndrome, obesity, hypertension, DM, cardiac disorders, advanced age, high ASA physical status have increased risk of hypoxemia. Therefore, supplemental oxygen is provided to all patients undergoing ERCP using standard nasal cannula that can provide maximum up to 6L/min but the Fio2 is not more than 40% . The presence of the Endoscope precludes the use of face mask for delivering higher concentrations of oxygen. High flownasal oxygen is a new approach that provides heated and moist oxygen at a much higher gas flow rate (up to 70L/min), Fio2 up to 100%, provides flow dependent positive airway pressure to increase end expiratory lung volume, thus decreasing the work of breathing. The HFNC is also used in perioperative setups including preoxygenation, airway management, awake intubation. However, use of HFNC has not been extensively studied in complex gastrointestinal procedures like ERCP.Thus, this study is intended to compare effect of high flow nasal cannula versus low flow nasal cannula on oxygenation in patients undergoing endoscopic retrograde cholangiopancreatography under sedation.
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