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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Pediatric patients for congenital cardiac surgery, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
I |
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. |