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CTRI Number  CTRI/2020/03/023753 [Registered on: 04/03/2020] Trial Registered Prospectively
Last Modified On: 27/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of nasal prongs in maintaining oxygenation without respiration in patients while giving general anaesthesia 
Scientific Title of Study   To evaluate the effectiveness of nasal prongs in maintaining apnoeic oxygenation in patients with simulated cervical spine immobilization 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
10964  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tanvi Bharadwaj 
Designation  DNB ANAESTHESIOLOGY 
Affiliation  NDMC Medical College and Hindu Rao Hospital 
Address  Department of Anaesthesiology NDMC Medical College and Hindu Rao Hospital Malka Ganj New Delhi

Central
DELHI
110001
India 
Phone  8861484626  
Fax    
Email  tanvibharadwaj4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Aashish Dang 
Designation  CMO Anaesthesiology 
Affiliation  NDMC Medical College and Hindu Rao Hospital 
Address  Department of Anaesthesiology NDMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL Malka Ganj New Delhi

Central
DELHI
110007
India 
Phone  9810710458  
Fax    
Email  dradang007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Tanvi Bharadwaj 
Designation  DNB ANAESTHESIOLOGY 
Affiliation  NDMC Medical College and Hindu Rao Hospital 
Address  Department of Anaesthesiology NDMC Medical College and Hindu Rao Hospital Malka Ganj New Delhi

Central
DELHI
110007
India 
Phone  8861484626  
Fax    
Email  tanvibharadwaj4@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology NDMC Medical College and Hindu Rao Hospital Malka Ganj New Delhi 110007 
 
Primary Sponsor  
Name  Department of AnaesthesiologyNDMC Medical College and Hindu Rao Hospital  
Address  Malka Ganj new Delhi 110007 
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 
Dr Tanvi Bharadwaj  NDMC Medical College and Hindu Rao Hospital  Department of Anaesthesiology ground floor OT Block Hindu Rao Hospital Malka Ganj new Delhi 110007
New Delhi
DELHI 
8861484626

tanvibharadwaj4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of Hindu Rao Hospital  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 
Intervention  Application of nasal prongs  While giving general anaesthesia, oxygen administered to the patient through nasal prongs by simulating difficult airway by application of MILS and observing vital parameters including saturation and arterial blood gas. 
Comparator Agent  Oxygen insufflation through nasal prongs during apneoa in test group versus No oxygen insufflation in the control group.  Oxygen insufflation through nasal prongs during apneoa in test group versus No oxygen insufflation in the control group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Weight- 50-80 kgs
Height- 150-180cms
ASA grade 1 and 2
Patients undergoing elective surgeries under general anaesthesia
 
 
ExclusionCriteria 
Details  Patients refusing to participate in study
Body Mass index of <18 and > 30 kg/m2
Patients having nasal obstruction or history of epistaxis.
Patients with anticipated difficult airway.
Patients having present or past history of difficult mask ventilation.
Modified mallampatti score 3 and 4
Patients having present grade 3a/3b or 4 laryngoscopy view(Yentis and Lee’s modification of Cormack and Lehane)
Patient having chronic obstructive pulmonary disease.
Reactive airway or parenchymal disease.
Patient with any anatomical deformity of spine
Patients with history of cardiac, respiratory, renal or hepatic disease
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Wether nasal prongs are effective in maintaining oxygen saturation during periods of apnea in patients with simulated cervical spine immobilisation  6 minutes or untill the saturation falls till 95% 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the safe apnoea time in group which will be only preoxygenated as compared to group receiving oxygen insufflation through nasal prongs during apneoa in addition to preoxygenation.  6 minutes or until the saturation falls to 95% 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Nasal prongs will be applied to evaluate it’s effectiveness in maintaining blood oxygen saturation in case of a extended apnoea due to a difficult airway which will be simulated by application of Manual In Line Stabilization of cervical spine. 
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