Techniques for Lung Deflation With Arndt® Blocker

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dammam University
ClinicalTrials.gov Identifier:
NCT02030795
First received: January 7, 2014
Last updated: June 28, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Spontaneous Pneumothorax
Other: Disconnection group
Other: Bronchial Suction group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lung Deflation With Arndt® Blocker During Video-Assisted Thoracoscopy: A Comparison of the Disconnection Technique With a Continuous Bronchial Suction

Resource links provided by NLM:


Further study details as provided by Dammam University:

Primary Outcome Measures:
  • time needed for lung collapse [ Time Frame: 3 min before one lung ventilation ] [ Designated as safety issue: Yes ]
    measured from the institution of OLV to the time of total lung collapse


Secondary Outcome Measures:
  • quality of lung collapse [ Time Frame: every 20 min intervals after one lung ventilation initiation ] [ Designated as safety issue: No ]
    The quality of lung collapse at 20 min intervals after one lung ventilation initiation according to a four-point ordinal scale,3, 8 ranging from 1 (extremely poor) to 4 (excellent). Extremely poor (Score 1) indicated no collapse; poor (Score 2) indicated that there is a partial collapse with interference with surgical exposure; good (Score 3) indicated that there is total collapse, but the lung still had residual air; and excellent (Score 4) indicated a complete collapse with perfect surgical exposure. The feasibility of this scale was investigated during six surgical procedures not included in the study.

  • Overall surgeon satisfaction [ Time Frame: 15 min after surgery ] [ Designated as safety issue: No ]
    Overall surgeon satisfaction with surgical conditions as assessed using a verbal analog scale (0 = unsatisfied to 10 = very satisfied)

  • Number of times that the fiberoptic bronchoscope required to assure proper position [ Time Frame: 5 min after reinflation of the surgical lung ] [ Designated as safety issue: No ]
    The number of times that the FOB was required to assure proper position or to perform further bronchial suction

  • Intraoperative hypoxemia [ Time Frame: For 2 hours during surgery ] [ Designated as safety issue: No ]
    Intraoperative hypoxemia (SaO2 < 92%)


Estimated Enrollment: 58
Study Start Date: January 2014
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Disconnection group
The single lumen tube was disconnected from the ventilator for 60 s allowing the surgical lung to collapse.
Other: Disconnection group
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
Active Comparator: Bronchial Suction group
The suction port of the bronchial blocker, and connected to -30 cm H2O of suction.
Other: Bronchial Suction group
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030795

Locations
Saudi Arabia
Dammam University
Al Khubar, Eastern, Saudi Arabia, 31952
Sponsors and Collaborators
Dammam University
  More Information

No publications provided

Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT02030795     History of Changes
Other Study ID Numbers: Anesth-Dec13
Study First Received: January 7, 2014
Last Updated: June 28, 2014
Health Authority: Saudi Arabia: Ministry of Higher Education

Keywords provided by Dammam University:
Thoracic surgery
Arndt® blocker
lung deflation
Disconnection technique
Continuous suction
Elective video-assisted thoracoscopic

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 11, 2014