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CTRI Number  CTRI/2020/03/023855 [Registered on: 09/03/2020] Trial Registered Prospectively
Last Modified On: 06/03/2020
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 oxygen delivery methods(nasal prongs and nasopharyngeal airway with t piece) for patients undergoing monitored anesthesia care in endoscopic procedures. 
Scientific Title of Study   Comparison of oxygen delivery methods for patient undergoing monitored anesthesia care in endoscopic procedures. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Birva Khara 
Designation  Associate professor 
Affiliation  Pramukh Swami medical college  
Address  Department of Anaesthesiology, ShreeKrishna hospital, Karamsad. Gujarat
NA
Anand
GUJARAT
388325
India 
Phone  9537122077  
Fax  -  
Email  birvank@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Birva Khara 
Designation  Associate professor 
Affiliation  Pramukh Swami medical college  
Address  Department of Anaesthesiology, ShreeKrishna hospital, Karamsad. Gujarat
NA
Anand
GUJARAT
388325
India 
Phone  9537122077  
Fax  -  
Email  birvank@charutarhealth.org  
 
Details of Contact Person
Public Query  
Name  Dr Shivangi Agrawal 
Designation  PG Resident 
Affiliation  Pramukh Swami medical college  
Address  Department of Anaesthesiology, ShreeKrishna hospital, Karamsad. Gujarat
NA
Anand
GUJARAT
388325
India 
Phone  8980823635  
Fax  -  
Email  shivangia410@gmail.com  
 
Source of Monetary or Material Support  
Shree Krishna Hospital Anand Sojitra Road Karamsad Gujarat 
 
Primary Sponsor  
Name  Pramukhswami medical college 
Address  Shree Krishna Hospital Karamsad Gujarat 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Birva Khara  Shree Krishna Hospital  Shree Krishna Hospital, Anand Sojitra Road, Karamsad Gujarat
Anand
GUJARAT 		 9537122077
-
birvank@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
H M Patel Centre for Medical Care and Education, Karamsad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (2) ICD-10 Condition: K703||Alcoholic cirrhosis of liver, (3) ICD-10 Condition: K229||Disease of esophagus, unspecified, (4) ICD-10 Condition: K509||Crohns disease, unspecified, (5) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nasal Prongs  Patient will be given oxygen via nasal prongs with FiO2 40-60%  
Comparator Agent  NIL  NIL 
Intervention  T piece via nasopharyngeal airway  Patient will be given oxygen through t piece via nasopharyngeal airway with FiO2 40-60% , Nasopharyngeal airway lubricated and inserted once patient reach desired level of sedation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients ASA I,II,III, IV undergoing flexible endoscopy under monitored anesthesia care 
 
ExclusionCriteria 
Details  1) Patient requiring endotracheal intubation
2) Patient who have endotracheal tube insitu
3) Inadequate NBM
4) Tracheostomised patient
5) Allergy to topical anesthetics
6) Nasal deformities(deformation of nasal septum, visible distorsion or deviation from midline of nasal septum)
7) Patient on anticoagulants and with deranged coagulation profile
8)Lack of informed consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Hypoxia   SPO2 less than 90 percentage for at least 15 secconds 
 
Secondary Outcome  
Outcome  TimePoints 
1) Vitals and sedation level
2) Adverse events
3)Need to insert nasopharyngeal airway in group A(nasal prongs group)
4) Patient satisfaction,Surgeons satisfaction 		 Baseline, on procedure table, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 40 min, 50 min, 60 min  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   10/03/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Patient will undergo pre-anesthesia workup ,written and informed consent will be taken. All patient will be kept nil by mouth 8 hrs for solid 2 hrs for clear liquid, patient with concurrent illness take medication.Preprocedural preaparation by lidocaine oral topical solution, topical pharyngeal spray with 10% lidocaine spray for upper endoscopy. Patient randomly allocated into two group using winpipe software a) nasal prongs b) t piece via nasopharyngeal airway with FiO2 between 40-60%. Patients vitals(Spo2, heart rate,respiratory rate,blood pressure) are monitored on table, every 5 mins till the end of procedure. Adverse events and correction done such as hypoxia- head tilt, chin lift,securing airway by nasopharyngeal airway, increase flow of O2 or intermittent O2 flush, bag and mask ventilation, bradycardia- fluid and vasopressor, body movement - additional dose of anesthetic drug, bleeding from nose - local pressure application, Aspiration- oral nasal suctioning interruption of procedure and securing definite airway , Ramsay sedation score will be maintained >4 during endoscopy. We focus on comparing two different methods of oxygen delivery in flexible endoscopic procedure and thereby finding out the best method of oxygen delivery for safe and efficient monitored anesthesia care for patients undergoing flexible endoscopic procedure.
 
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