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CTRI Number  CTRI/2017/09/009610 [Registered on: 04/09/2017] Trial Registered Retrospectively
Last Modified On: 16/12/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of two methods of positioning endotracheal tube in chidren undergoing surgery for congenital heart defect repair 
Scientific Title of Study   Endotracheal tube positioning in pediatric cardiac patients: A comparative evaluation of two methods 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Satyen Parida 
Designation  Associate Professor 
Affiliation  JIPMER, Puducherry 
Address  Dept of Anesthesiology & Critical Care JIPMER Dhanvantari Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  9940973502  
Fax    
Email  jipmersatyen@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satyen Parida 
Designation  Associate Professor 
Affiliation  JIPMER, Puducherry 
Address  Dept of Anesthesiology & Critical Care JIPMER Dhanvantari Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  9940973502  
Fax    
Email  jipmersatyen@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Satyen Parida 
Designation  Associate Professor 
Affiliation  JIPMER, Puducherry 
Address  Dept of Anesthesiology & Critical Care JIPMER Dhanvantari Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  9940973502  
Fax    
Email  jipmersatyen@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Post-Graduate Medical Education and Research, Dhanvantari Nagar, PUDUCHERRY - 605006 
 
Primary Sponsor  
Name  JIPMER 
Address  Dhanvantari Nagar, Puducherry 
Type of Sponsor  Research institution 
 
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 Satyen Parida  Department of Anesthesiology & Critical Care,  JIPMER, Dhanvantari Nagar,
Pondicherry
PONDICHERRY 
9940973502

jipmersatyen@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (Human Studies), JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pediatric patients for congenital cardiac surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endotracheal tube placement based on depth markers aligned against the vocal cords 
Intervention  II  Endobronchial intubation followed by withdrawal of the endotracheal tube above the carina 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Pediatric patients of age < 10 yrs, undergoing elective cardiac surgery under general anesthesia
 
 
ExclusionCriteria 
Details  Patients with pulmonary diseases, such as bronchial asthma
Abnormal breath sounds
Malformations of the trachea or bronchus on CXR
Difficulties in neck flexion or extension
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Distance between the tip of the endotracheal tube to the carina between the two groups  1. One minute after intubation in neutral, flexed and extended position

2. Five minutes after initiation of cardiopulmonary bypass in neutral position

3. Five minutes after separation from cardiopulmonary bypass in neutral position 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of re-positioning of endotracheal tube based on fibreoptic view   1. One minute after intubation in neutral, flexed and extended position

2. Five minutes after initiation of cardiopulmonary bypass in neutral position

3. Five minutes after separation from cardiopulmonary bypass in neutral position 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2012 
Date of Study Completion (India) 30/04/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The patients will be randomly allocated to one of two groups according to a computer-generated random number. Demographic data will be obtained from patients’ case file. Data concerning type of operation done, ETT (uncuffed polyvinyl chloride tube) size, position, adjustment, type of endotracheal intubation and level of carina are to be observed. Intravenous induction with sodium thiopentone 5mg/ kg will be carried out and endotracheal intubation is to be achieved with 0.2mg/ kg of vecuronium. For cases of nasotracheal intubation the nostrils will be prepared with nasal drops and the ETT lubricated with 2% lidocaine gel.

In Group I, after tracheal intubation, the patient is to be manually ventilated, and both lung fields auscultated to confirm that the ETT has been placed correctly in the trachea. With the head held at the midline in the neutral position, the ETT will be advanced gently until it enters a mainstem bronchus, usually on the right side. This event is to be confirmed by a loss of breathing sounds, usually on the left side. The ETT will then be slowly withdrawn until equal breath sounds on both sides return. Before being secured at the upper lip with adhesive tape, the ETT will be withdrawn a further 2 cm in the children aged below 5.0 yr or 3 cm in those aged between 5.1 and 10.0 yr.

In Group II, the ETT will be placed with the recommended centimeter marking aligned with the level of the vocal cords. The ETT will be set at the level of the vocal cords (i.e., the 3-cm mark for tubes with an internal diameter (ID) of 3 or 3.5 cm, 4-cm for tubes with ID 4 or 4.5 cm, 5-cm for tubes with ID 5 or 5.5 cm and 6-cm for tubes with ID 6 or 6.5 cm)  . Correct placement of ETT will then ascertained by chest auscultation and capnography.

The patients are to be kept in an anatomically neutral position and bronchoscopic evaluation is to be carried out. A fibreoptic bronchoscope (FOB) will be inserted through an ETT/ventilator adapter, which allows the procedure during mechanical ventilation. A single anesthesiologist, who will be blinded to the method of intubation, will perform all the bronchoscopic evaluations. The first mark is to be made on the FOB corresponding to the proximal end of the ETT when the tip of the FOB touches the carina. The FOB will then withdrawn until the ETT tip is visualized, and a second mark is made on the FOB. The distance between these two marks on the FOB will correspond to the distance from the tip to the carina (T-C). After measuring the T-C in the neutral position, the changes in this distance will be measured after full flexion and full extension of the neck. When endobronchial intubation is suspected with a bronchoscopic examination, the ETT distance in the main bronchus will measured by withdrawing both the ETT and bronchoscope to the carina. An increase or a decrease of the T-C would correspond to ETT displacement toward the vocal cords and the carina respectively. During the period of cardiopulmonary bypass (CPB) the bronchoscopic evaluation would be repeated when ventilation is stopped and a repeat evaluation would also be done after the lungs are re-inflated. Both intra-op evaluations are to be done in neutral position and their T-C distance compared to the T-C distance obtained during initially prior to start of surgery.

 

The frequency of endobronchial intubation is to be compared using Χ2 test. The difference between the T-C and the intended position of the tube tip from the carina is to be analysed by Student’s t-test. The differences among the groups would be analysed using ANOVA. Statistical significance is established at P < 0.05. The data will be represented as mean + SD.    
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