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

A Prospective Randomised Controlled Trial To Compare The Stability Of Bronchial Blocker Between Extraluminal And Intraluminal Placement In Adult Thoracic Surgery - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066317
Enrollment
136
Registered
2024-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere

Interventions

Intervention1: Extraluminal bronchial blocker placement: After laryngoscopy, a fixed angled tip 7F bronchial blocker (BB) will be inserted with the angled tip directed towards the side to be blocked.

Sponsors

Tata memorial Centre Mumbai
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The number of patients in each group who have a BB dislodgement event needing repositioning at least once intraoperatively.Timepoint: 1. At initial Placement 2. After change of position 3.At start of surgery 4.At end of OLV 5. At any other time point of displacement of BB

Secondary

MeasureTime frame
1. Number of patients in whom there was failure to place BB in each group 2. Total number of episodes of intraoperative repositionings in each group. 3. Average time taken for insertion of BB i.e. time from insertion of bronchoscope to optimum placement in each group 4. Average time taken per intraoperative repositioning in each group 5. Subjective ease of insertion as reported by the attending anaesthetist 6. Quality of lung collapse at 5, 10 and 30 minutes after opening of thorax Timepoint: 1. At initial Placement 2. After change of position 3.At start of surgery 4.At end of OLV 5. At any other time point of displacement of BB

Countries

India

Contacts

Public ContactSwapnil Singh

Tata memorial Centre, Mumbai

mshetmahajan@hotmail.com9819372075

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026