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CTRI Number  CTRI/2018/10/016103 [Registered on: 22/10/2018] Trial Registered Prospectively
Last Modified On: 18/10/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   The Relationship between Complications that may arise Before, During and After Surgery and the Number of Eosinophils in the Blood. 
Scientific Title of Study   Adverse Perioperative Events and Eosinophil Count 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr N M Lyngdoh 
Designation  Associate Professor 
Affiliation  NEIGRIHMS 
Address  Dept. of Anaesthesiology and Critical Care North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences Mawdiangdiang Shillong
Dept. of Anaesthesiology and Critical Care North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences Mawdiangdiang Shillong 793018
East Khasi Hills
MEGHALAYA
793018
India 
Phone  9862230765  
Fax    
Email  narilyngdoh@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr N M Lyngdoh 
Designation  Associate Professor 
Affiliation  NEIGRIHMS 
Address  Dept. of Anaesthesiology and Critical Care North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences Mawdiangdiang Shillong
Dept. of Anaesthesiology and Critical Care North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences Mawdiangdiang Shillong 793018
East Khasi Hills
MEGHALAYA
793018
India 
Phone  9862230765  
Fax    
Email  narilyngdoh@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr N M Lyngdoh 
Designation  Associate Professor 
Affiliation  NEIGRIHMS 
Address  Dept. of Anaesthesiology and Critical Care North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences Mawdiangdiang Shillong
Dept. of Anaesthesiology and Critical Care North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences Mawdiangdiang Shillong 793018
East Khasi Hills
MEGHALAYA
793018
India 
Phone  9862230765  
Fax    
Email  narilyngdoh@yahoo.co.in  
 
Source of Monetary or Material Support  
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences Mawdiangdiang Shillong-793018 
 
Primary Sponsor  
Name  North Eastern Indira Gandhi Research Institute of Health and Medical Sciences 
Address  Mawdiangdiang, Shillong-793018, Meghalaya 
Type of Sponsor  Research institution and hospital 
 
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 N M Lyngdoh  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences   Preanaesthetic checkup clinic( room no.205), ground floor OT and 3rd floor OT, Dept. of Anaesthesiology and Critical Care, Mawdiangdiang, Shillong
East Khasi Hills
MEGHALAYA 		 9862230765

narilyngdoh@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, NEIGRIHMS  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, (2) ICD-10 Condition: R068||Other abnormalities of breathing,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients of either sex, in the age group of 3 years and above, ASA physical status I or II ,posted for elective surgery, who require general anaesthesia and endotracheal intubation 
 
ExclusionCriteria 
Details  Age less than 3 years,patients cardiac disease, upper respiratory tract infection within the last 2 weeks, difficult airway requiring more than 3 intubation attempts, surgeries involving airway, absolute eosinophil count >1000mm3.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Any adverse respiratory event that occurs at any point of time in the intraoperative and postoperative period will be recorded. An adverse respiratory event will include any or all of the following: bronchospasm, laryngospasm, a fall in SPO2 to less than 95%, cough and stridor.  From the time of induction of anaesthesia to 24 hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
Any other adverse event that occurs at any point of time in the intraoperative and postoperative period will be recorded.  From the time of induction of anaesthesia to 24 hours post operatively 
 
Target Sample Size   Total Sample Size="346"
Sample Size from India="346" 
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)   01/11/2018 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   I want to study the relationship between eosinophil count and any adverse events that may occur in the perioperative period. The rationale behind this study is that studies have shown a correlation between airway hyperreactivity and increased blood eosinophil count . Airway hyperreactivity in turn can precipitate adverse respiratory events in the perioperative period. The research hypothesis is that there is a positive correlation between blood eosinophil count and  adverse  perioperative respiratory events. If the results of this study support the research hypothesis then it will aid in our preparedness to deal with such complications and even take preemptive steps to prevent such events in future.  
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