A study to check the efficacy of right-sided double lumen tube in surgeries of thoracic region.

Completed

• Conditions: Malignant neoplasm of unspecifiedpart of bronchus or lung,

• Registration Number: CTRI/2023/03/050319
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

One-lung ventilation is a procedure where one of the two lungs is ventilated while the other one is not ventilated. It facilitates minimally invasive surgery. Double-lumen tubes (DLTs) are the most commonly used devices for one-lung ventilation. Both right and left-sided DLTs are available. However, left-sided DLTs are commonly used as Right-sided DLTs carry a risk of lack of ventilation to the upper part of the right lung. It leads to a drop in the level of oxygen in the blood. However, with the use of pediatric bronchoscopes, it is now possible to avoid this complication during surgery by achieving the correct position of the right-sided DLTs.

Hence, we wish to do a prospective, observational study to know the safety and efficacy associated with right-sided DLTs.

Written informed consent will be taken a day prior to surgery.

 We will observe the process of insertion of right-sided DLTs, the incidence of intraoperative drop in the oxygenation, and the postoperative complications related to the lungs.

 The patient will be followed up from the day of surgery till discharge from the hospital for any post-operative pulmonary complications.

There is no risk involved to the patient by participating in the study, as it is a purely observational study.

The patient’s identity will be kept confidential throughout the study.

The patient can withdraw from the study at any point in time. The clinical management of the patient won’t be affected by the decision to participate or withdraw from the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-03
• Last Update Posted: 2023-09-27
• Study Completion: 2024-10-24

Recruitment & Eligibility

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

Inclusion Criteria

All adult patients undergoing one-lung ventilation using right-sided DLTs placed in the right main bronchus.

Exclusion Criteria

• 1.Emergency surgery 2.Patient < 18 years of age 3.Endobronchial masses inside the trachea, right mainstem bronchus (RMB), or bronchus intermedius (BI) 4.Radiological evidence of compression or deviation of the trachea, RMB, or BI.
• 5.Patients planned for right pneumonectomy/right bronchial sleeve surgery or right bronchotomy.
• 6.Patient with anatomical variation in the trachea e.g. Pig Bronchus 7.Patients with a height of less than 150 cm 8.Patients with tracheostomy or anticipated difficult airway.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of intra-operative hypoxia associated with the use of Right-sided double lumen tube	at 30 minutes, 60 minutes, 90 minutes, and 120 minutes after the beginning of one-lung ventilation.

Secondary Outcome Measures

Name	Time	Method
the time taken for the insertion of RDLT, number of attempts of intubation, rate of first attempt success, and rate of dislodgement of RDLT	at 30 minutes, 60 minutes, 90 minutes, and 120 minutes after the beginning of one-lung ventilation.

Trial Locations

Locations (1)

Tata Memorial Hospital, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital, Mumbai

🇮🇳Mumbai, MAHARASHTRA, India

Dr Swapnil Parab

Principal investigator

02224177000

swapnil.parab@gmail.com