Comparison of two methods of positioning endotracheal tube in chidren undergoing surgery for congenital heart defect repair

Completed

• Conditions: Pediatric patients for congenital cardiac surgery

• Registration Number: CTRI/2017/09/009610
• Lead Sponsor: JIPMER

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 The ETT will then be slowly withdrawn until equal breath sounds on both sides return. Before being secured at the upper lip with adhesive tape, the ETT will be withdrawn a further 2 cm in the children aged below 5.0 yr or 3 cm in those aged between 5.1 and 10.0 yr.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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-04
• Study Completion: 2015-04-30
• Last Update Posted: 2017-12-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Pediatric patients of age < 10 yrs, undergoing elective cardiac surgery under general anesthesia.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Incidence of re-positioning of endotracheal tube based on fibreoptic view	1. One minute after intubation in neutral, flexed and extended position

Trial Locations

Locations (1)

Department of Anesthesiology & Critical Care,; 🇮🇳 Pondicherry, PONDICHERRY, India

Department of Anesthesiology & Critical Care,

🇮🇳Pondicherry, PONDICHERRY, India

Dr Satyen Parida

Principal investigator

9940973502

jipmersatyen@gmail.com