Techniques for Lung Deflation With Arndt® Blocker
Primary Purpose
Spontaneous Pneumothorax
Status
Completed
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Disconnection group
Bronchial Suction group
Sponsored by
About this trial
This is an interventional treatment trial for Spontaneous Pneumothorax focused on measuring Thoracic surgery, Arndt® blocker, lung deflation, Disconnection technique, Continuous suction, Elective video-assisted thoracoscopic
Eligibility 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
Sites / Locations
- Dammam University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Disconnection group
Bronchial Suction group
Arm Description
The single lumen tube was disconnected from the ventilator for 60 s allowing the surgical lung to collapse.
The suction port of the bronchial blocker, and connected to -30 cm H2O of suction.
Outcomes
Primary Outcome Measures
time needed for lung collapse
measured from the institution of OLV to the time of total lung collapse
Secondary Outcome Measures
quality of lung collapse
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
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
The number of times that the FOB was required to assure proper position or to perform further bronchial suction
Intraoperative hypoxemia
Intraoperative hypoxemia (SaO2 < 92%)
Full Information
NCT ID
NCT02030795
First Posted
January 7, 2014
Last Updated
April 3, 2015
Sponsor
Imam Abdulrahman Bin Faisal University
1. Study Identification
Unique Protocol Identification Number
NCT02030795
Brief Title
Techniques for Lung Deflation With Arndt® Blocker
Official Title
Lung Deflation With Arndt® Blocker During Video-Assisted Thoracoscopy: A Comparison of the Disconnection Technique With a Continuous Bronchial Suction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imam Abdulrahman Bin Faisal University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
Most Middle Eastern and British thoracic anesthesiologists (100% and 98%, respectively) are using a double-lumen endobronchial tube (DLT) as the first-choice lung separation technique, 1-2 although the intubation with a single lumen tube (SLT) could be easier. However, the use of a bronchial blocker has a special concern as it takes longer time to collapse the operative lung,3 which precludes its widespread acceptance for video-assisted thoracoscopic (VATS) procedures because of delayed insertion of the trocars.
The wire-guided Arndt® endobronchial blocker (Cook® Critical Care, Bloomington, IN) takes longer time for lung collapse than the Univent® tube (approximately, 26 min vs. 19 min, respectively; P<0.006),3 that may be due to its narrower inner lumen (1.4 mm vs. 2.0 mm, respectively).
There are different techniques described to speed of lung collapse during the use of Arndt® endobronchial blocker. These include the disconnecting of the SLT from the ventilator and allowing both lungs to collapse before inflation of the bronchial blocker cuff, 4-5 or bronchial suction either through the fiberoptic bronchoscope after deflation of the bronchial cuff and cessation of ventilation before re-inflation of the bronchial cuff, or through a barrel part of a 3-mL syringe attached to the suction port of the bronchial blocker.3 The use of a modified disconnection technique for deflation of Arndt® endobronchial blocker had a comparable degree of lung collapse with the use of DLT during VATS procedures in patients presented with pneumothorax.5 However, compared with the bronchial suction, the disconnection technique may carry a risk of blood or infected secretions contaminating the dependent lung.6
To the best of our knowledge, the comparison of the efficacy of disconnection and bronchial suction techniques to facilitate the deflation of Arndt® blocker during thoracoscopic surgery has not yet been studied.
In all patients, standard monitors and state and response entropy (SE and RE, respectively) based-depth of anaesthesia will be applied. The radial artery will be catheterized.
Anesthetic technique is standardized in all studied patients. The experienced attending anesthesiologist (>10 yrs.), who will give the anesthetic and places the Arndt® blocker will not be blinded to group assignment and will not be involved in the collection of outcome data.
After preoxygenation, anesthesia will be induced using propofol 1.5-3 mg/kg and target-controlled infusion (TCI) of remifentanil at an effect-site concentration (Ce) of 4 ng/mL, to achieve the SE values below 50 and the difference between RE and SE below 10.
Cisatracurium (0.2 mg/kg) will be given to facilitate the tracheal intubation with a SLT, size 8.0 mm for women and 8.5 mm for men. Then a 9.0 F, 78-cm Arndt® blocker will be advanced through the blocker port of its multiport adapter and the wire loop will be coupled with a pediatric fiberoptic bronchoscope (FOB) that has been introduced through the fiberoptic port. The Arndt® blocker will be introduced to the targeted bronchus. The correct position of the Arndt® blocker wil be confirmed with a FOB.
Anesthesia will be maintained with 0.7-1.5 minimum alveolar concentration (MAC) of sevoflurane and remifentanil Ce of 2-4 ng/ml to maintain the SE values below 50, the difference between RE and SE below 10 and the mean arterial blood pressure (MA) and heart rate <20% of baseline values. Cisatracurium increments will be used to maintain surgical relaxation.
Patients' two lungs (TLV) will be mechanically ventilated with fraction of inspired oxygen (FiO2) of 0.4 in air, tidal volume (VT) of 8 mL/kg, inspiratory to expiratory (I: E) ratio of 1:2.5 and PEEP of 5 cm H2O, and respiratory rate will be adjusted to achieve a PaCO2 of 35-45 mm Hg.
After the positioning of the patient in the lateral decubitus position, the position of the blocker will be reconfirmed, the blocker cuff will be inflated with a titrated amount of air to create a seal under direct visualization of FOB and the wire loop will be removed.
All surgical procedures will be performed by the same surgeons who are blinded for the lung collapse technique and who are absent from the operating room during placement of the BB and deflation of the lung.
The VATS procedure begins with the exploration of the pleural cavity using a 30° video thoracoscopic camera through a 1.5 cm single skin incision with the use of 1-3 trocars which enabled the thoracoscopic instruments to move the lung.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Pneumothorax
Keywords
Thoracic surgery, Arndt® blocker, lung deflation, Disconnection technique, Continuous suction, Elective video-assisted thoracoscopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Disconnection group
Arm Type
Active Comparator
Arm Description
The single lumen tube was disconnected from the ventilator for 60 s allowing the surgical lung to collapse.
Arm Title
Bronchial Suction group
Arm Type
Active Comparator
Arm Description
The suction port of the bronchial blocker, and connected to -30 cm H2O of suction.
Intervention Type
Other
Intervention Name(s)
Disconnection group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Bronchial Suction group
Intervention Description
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.
Primary Outcome Measure Information:
Title
time needed for lung collapse
Description
measured from the institution of OLV to the time of total lung collapse
Time Frame
3 min before one lung ventilation
Secondary Outcome Measure Information:
Title
quality of lung collapse
Description
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.
Time Frame
every 20 min intervals after one lung ventilation initiation
Title
Overall surgeon satisfaction
Description
Overall surgeon satisfaction with surgical conditions as assessed using a verbal analog scale (0 = unsatisfied to 10 = very satisfied)
Time Frame
15 min after surgery
Title
Number of times that the fiberoptic bronchoscope required to assure proper position
Description
The number of times that the FOB was required to assure proper position or to perform further bronchial suction
Time Frame
5 min after reinflation of the surgical lung
Title
Intraoperative hypoxemia
Description
Intraoperative hypoxemia (SaO2 < 92%)
Time Frame
For 2 hours during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dammam University
City
Al Khubar
State/Province
Eastern
ZIP/Postal Code
31952
Country
Saudi Arabia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25564782
Citation
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.
Results Reference
derived
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Techniques for Lung Deflation With Arndt® Blocker
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