Techniques for Lung Deflation With Arndt® Blocker

NCT02030795 | Completed Phase 2 DMC

• 1 other identifier: Anesth-Dec13
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The use of wire-guided Arndt® endobronchial blocker does not gain widespread acceptance during video-assisted thoracoscopy (VATS) because it takes longer time to collapse the operative lung especially in patients with chronic obstructive lung disease (COPD). The use of a disconnection technique for deflation of Arndt® blocker had a comparable degree of lung collapse with the use of double-lumen tubes. However, it carries a risk of blood or infected secretions contaminating the dependent lung. We hypothesise that the use bronchial suction of through a barrel part of a 1-mL insulin syringe attached to the suction port of the bronchial blocker would be associated with comparable time to optimum lung collapse with the disconnection technique. After ethical approval, 58 patients with spontaneous pneumothorax scheduled for elective VATS using Arndt blocker® for lung separation will be included in this prospective, randomized, double-blind study. Patients will be randomly assigned to deflate the blocker with either disconnecting the endotracheal tube from the ventilator for 60 s. prior to inflation of the bronchial blocker allowing both lungs to collapse, or attaching -20 cm H2O of suction to the suction port of the blocker through the barrel part of a 1-mL insulin syringe (n = 29 for each group).

Conditions

Spontaneous Pneumothorax

Keywords

Thoracic surgery; Arndt® blocker; lung deflation; Disconnection technique; Continuous suction; Elective video-assisted thoracoscopic

Outcome Measures

Primary Outcomes (1)

• time needed for lung collapse

  measured from the institution of OLV to the time of total lung collapse

  3 min before one lung ventilation

Secondary Outcomes (4)

• quality of lung collapse

  every 20 min intervals after one lung ventilation initiation

• Overall surgeon satisfaction

  15 min after surgery

• Number of times that the fiberoptic bronchoscope required to assure proper position

  5 min after reinflation of the surgical lung

• Intraoperative hypoxemia

  For 2 hours during surgery

Study Arms (2)

Disconnection group

ACTIVE COMPARATOR

The single lumen tube was disconnected from the ventilator for 60 s allowing the surgical lung to collapse.

Other: Disconnection group

Bronchial Suction group

ACTIVE COMPARATOR

The suction port of the bronchial blocker, and connected to -30 cm H2O of suction.

Other: Bronchial Suction group

Interventions

Disconnection group OTHER

The blocker cuff was deflated, the single lumen tube was disconnected from the ventilator for 60 s allowing the surgical lung to collapse, then the cuff was re-inflated with the same amount of air as determined previously and the ventilator was reconnected to the single lumen tube

Disconnection group

Bronchial Suction group OTHER

The barrel part of a 1-mL insulin syringe was attached to the suction port of the bronchial blocker, and connected to -30 cm H2O of suction.

Bronchial Suction group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical class (II-III)
• Need of one lung ventilation

You may not qualify if:

• New York Heart Association class\> II.
• Forced vital capacity (FVC) or forced expiratory volume in 1 second (FEV1) (\< 50% of the predicted values).
• Severe asthma.
• Pregnancy.
• Body mass index \>35 kg/m2.
• Anticipated difficult intubation.
• Patients requiring absolute lung separation.
• Known lesions along the path of the bronchial blockers.
• Need preoperative ventilatory support.
• Post-thoracic surgery pneumothorax.
• Traumatic pneumothorax.
• Emergency surgery.
• History of lung resection.
• Calculated ipsilateral percentage pneumothorax size exceeded 20% as estimated by helical CT-derived Collins'formula

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Dammam University

Khobar, Eastern Province, 31952, Saudi Arabia

Location

Related Publications (1)

• El-Tahan MR. A comparison of the disconnection technique with continuous bronchial suction for lung deflation when using the Arndt endobronchial blocker during video-assisted thoracoscopy: A randomised trial. Eur J Anaesthesiol. 2015 Jun;32(6):411-7. doi: 10.1097/EJA.0000000000000194.

  PMID: 25564782 DERIVED

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 6, 2015

Record last verified: 2015-04

Locations

SA (1)