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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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
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 
 
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
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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