MedPath

A study comparing two methods of insertion of a device used for collapsing one lung for chest cavity surgery in adult cancer patients.

Phase 3
Conditions
Health Condition 1: O- Medical and SurgicalHealth Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere
Registration Number
CTRI/2024/04/066317
Lead Sponsor
Tata memorial Centre Mumbai
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Patients who are deemed suitable for both extraluminal as well as intraluminal placement of BB by a thoracic anaesthetist. This would typically include patients in whom a cuffed single lumen endotracheal tube of size 7.5 or above is considered appropriate i.e. most male patients and female patients with height above 155 cm

2.Patients in whom a bronchial blocker with a fixed angle tip is chosen for lung isolation e.g. Coopdech blocker, Tappa blocker or Fuji blocker

Exclusion Criteria

1.Patients with risk of cross contamination of lung with blood or infected secretions, or those with bronchopleural fistula

2.Patients in whom EZ or Arndt blocker is used for lung isolation

3.Patients with abnormal tracheobronchial anatomy detected on radiological imaging or flexible bronchoscopy

4.Patients with an anticipated difficult airway

5.Patients with unanticipated difficult airway e.g. those requiring more than 3 attempts at endotracheal intubation, those requiring rescue measures to maintain oxygenation, etc

6.Patients belonging to ASA III physical status

7.Patients at high risk of regurgitation and aspiration

8.Patients in whom a 7F BB is unable to achieve a seal (and therefore isolation)

9.Patients who cannot give valid consent

10.Pregnancy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The number of patients in each group who have a BB dislodgement event needing repositioning at least once intraoperatively.Timepoint: 1. At initial Placement <br/ ><br>2. After change of position <br/ ><br>3.At start of surgery <br/ ><br>4.At end of OLV <br/ ><br>5. At any other time point of displacement of BB <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
1.Number of patients in whom there was failure to place BB in each group <br/ ><br>2.Total number of episodes of intraoperative repositionings in each group. <br/ ><br>3.Average time taken for insertion of BB i.e. time from insertion of bronchoscope to optimum placement in each group <br/ ><br>4.Average time taken per intraoperative repositioning in each group <br/ ><br>5.Subjective ease of insertion as reported by the attending anaesthetist <br/ ><br>6.Quality of lung collapse at 5, 10 and 30 minutes after opening of thorax <br/ ><br>Timepoint: 1. At initial Placement <br/ ><br>2. After change of position <br/ ><br>3.At start of surgery <br/ ><br>4.At end of OLV <br/ ><br>5. At any other time point of displacement of BB <br/ ><br>
© Copyright 2025. All Rights Reserved by MedPath