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CTRI Number  CTRI/2018/01/011089 [Registered on: 02/01/2018] Trial Registered Prospectively
Last Modified On: 13/09/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Assessment of Left side of Heart by ultrasonography of heart in bluish discoloured children undergoing corrective operation.  
Scientific Title of Study   Mitral Annular Plane Systolic Excursion/Left ventricular length (MAPSE/L) – A novel index for assessing left ventricular longitudinal function in pediatric tetrology of fallot patients undergoing surgical repair. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srinath D 
Designation  Senior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive care, 4th floor, Nehru Hospital, PGIMER, Sector 12
Cardiac Anaesthesia Office, 4016, 4th floor, C block, Advanced Cardiac Center, PGIMER, Chandigarh-12.
Chandigarh
CHANDIGARH
160012
India 
Phone  8437300405  
Fax    
Email  drsrinath88@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Goverdhan Dutt Puri 
Designation  Professor and Head 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive care, 4th floor, Nehru Hospital, PGIMER, Sector 12
Cardiac Anaesthesia Office, 4016, 4th floor, C block, Advanced Cardiac Center, PGIMER, Chandigarh-12.
Chandigarh
CHANDIGARH
160012
India 
Phone  9815199717  
Fax    
Email  gdpuri007@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Goverdhan Dutt Puri 
Designation  Professor and Head 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive care, 4th floor, Nehru Hospital, PGIMER, Sector 12
Cardiac Anaesthesia Office, 4016, 4th floor, C block, Advanced Cardiac Center, PGIMER, Chandigarh-12.
Chandigarh
CHANDIGARH
160012
India 
Phone  9815199717  
Fax    
Email  gdpuri007@hotmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research (PGIMER) 
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Research  
Address  SECTOR-12, CHANDIGARH-160012.  
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 
Srinath D  Advanced cardiac centre  PGIMER, Sector-12, Chandigarh.
Chandigarh
CHANDIGARH 		 8437300405

drsrinath88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients of Tetrology of Fallot of age less than 15 years undergoing total intracardiac corrective surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Pediatric patients with tetrology of fallot physiology posted for total intracardiac repair under cardiopulmonary bypass will be included in this study. 
 
ExclusionCriteria 
Details  Patients with perforated viscus, esophageal stricture, esophageal diverticulum, esophageal injury, tracheoesophageal fistula, previous upper Gastrointestinal surgery, coagulopathy and thrombocytopenia are contraindicated for transesophageal echocardiography will be excluded.
Patients with absent pulmonary valve syndrome will be excluded.
Patients not willing to participate in the study will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the correlation of Mitral Annular Plane Systolic Excursion/Left Ventricular Length with Left Ventricle Ejection Fraction in pediatric tetrology of fallot patients undergoing cardiac surgery for total intracardiac repair.  1) TTE on table before induction of anaesthesia
2) TTE on table after induction of anaesthesia
3) TEE on table before CPB
4) TEE on table after CPB
5) TTE in ICU in Post Operative Day (POD) 1
6) TTE at the time of discharge from ICU
7) TTE at 3 month follow up
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the relationship of MAPSE/L with other echocardiography parameters such as Left Ventricle Global Longitudinal Strain by speckle tracking method, Right Ventricle Global Longitudinal Strain, Right Ventricle Fractional Area Change, Tricuspid Annular Plane Systolic Excursion, and Left Ventricle Diastolic function indices.  1) TTE on table before induction of anaesthesia
2) TTE on table after induction of anaesthesia
3) TEE on table before CPB
4) TEE on table after CPB
5) TTE in ICU in Post Operative Day (POD) 1
6) TTE at the time of discharge from ICU
7) TTE at 3 month follow up
 
To use MAPSE/L in prediction of early surgical outcomes like Left Ventricle dysfunction, low cardiac output syndrome, mechanical ventilation, Intensive care unit stay  Immediate postoperative period and at 3 months 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/01/2018 
Date of Study Completion (India) 08/08/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Comparison of oropharyngeal leak pressure of air-Qâ„¢, i-gelâ„¢,and laryngeal mask airway Supremeâ„¢ in adult patients during general anesthesia: A randomized controlled trial Saudi Journal of Anesthesia Year : 2017 | Volume : 11 | Issue : 4 | Page : 390-395 DOI: 10.4103/sja. SJA_149_17 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a prospective observational study to assess the left ventricle longitudinal function by using a novel index (MAPSE/L). The primary outcome of this study will be assessing the correlation of Mitral Annular Plane Systolic Excursion/ Left Ventricle Length (MAPSE/L)  with Left Ventricle Ejection Fraction in pediatric Tetrology of Fallot patients undergoing surgery for total intracardiac repair. This study will be conducted in Advanced Cardiac Center, PGIMER, chandigarh. The secondary outcomes of this study will be assessing the relationship of MAPSE/L with other echocardiographic parameters such as Left ventricle Global Longitudinal Strain, Right ventricle Global Longitudinal Strain, Tricuspid Annular Plane Systolic Excursion, Right Ventricle Fractional area Change and Left ventricle diastolic function indices. Also, in this study,  prediction of low cardiac output syndrome, left ventricle dysfunction, prolonged mechanical ventilation and prolonged ICU stay after total intracardiac repair of Tetrology of Fallot by using MAPSE/L.    
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