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CTRI Number  CTRI/2015/09/006170 [Registered on: 09/09/2015] Trial Registered Retrospectively
Last Modified On: 03/09/2015
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Complications Of Tracheal Intubation In Critically Ill Pediatric Cancer Patients 
Scientific Title of Study   Complications Of Tracheal Intubation In Critically Ill Pediatric Cancer Patients 
Trial Acronym  COTI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Atul P Kulkarni 
Designation  Professor and Head Division of critical care medicine 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia critical care and pain, Tata Memorial hospital, Parel, mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  kaivalyaak@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Atul P Kulkarni 
Designation  Professor and Head Division of critical care medicine 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia critical care and pain, Tata Memorial hospital, Parel, mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  kaivalyaak@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Atul P Kulkarni 
Designation  Professor and Head Division of critical care medicine 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia critical care and pain, Tata Memorial hospital, Parel, mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  kaivalyaak@yahoo.co.in  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  none 
Address  Not applicable 
Type of Sponsor  Other [] 
 
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 Atul P kulkarni  Tata Memorial hospital, parel, Mumbai  Division of Critical Care, Department of Anaesthesia critical care and Pain,Tata Memorial hospital Parel Mumbai
Mumbai
MAHARASHTRA 		 022-24177049
022-24146937
kaivalyaak@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pediatric criically ill cancer patients ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All ICU medical admission of age less than or equal to 12 years needing tracheal intubation with conventional laryngoscopy and intubation. 
 
ExclusionCriteria 
Details  1. Patients older than 12 years.
2. Intubations done during cardiopulmonary resuscitation,
3. Awake fibreoptic intubation or intubations done immediately after unplanned extubation and
4. Patients with mediastinal mass with Computed tomography (CT) scan documented tracheal compression or deviation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify and quantify the frequency of complications during intubation in critically ill pediatric cancer patients  at intubation time 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/11/2013 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A retrospective study of identifying and quantifying complications of tracheal intubation in critically ill pediatric cancer patients. 
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