Spontaneous PneumothoraxPhase 2NCT02030795
Techniques for Lung Deflation With Arndt® Blocker
A Phase 2 study testing Disconnection group and Bronchial Suction group in people with Spontaneous Pneumothorax, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spontaneous Pneumothorax
- What is being tested?
- Disconnection group and Bronchial Suction group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2014to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical class (II-III)
- Need of one lung ventilation
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Deflation With Arndt® Blocker During Video-Assisted Thoracoscopy: A Comparison of the Disconnection Technique With a Continuous Bronchial Suction
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.
Read more
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).
Read the 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.
- Conditions
- Spontaneous Pneumothorax
- Being tested
- Disconnection group, Bronchial Suction group
- Keywords
- Thoracic surgery, Arndt® blocker, lung deflation, Disconnection technique, Continuous suction, Elective video-assisted thoracoscopic
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disconnection groupOther
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
Bronchial Suction groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Disconnection group | Active comparator | The single lumen tube was disconnected from the ventilator for 60 s allowing the surgical lung to collapse. Receives: Other: Disconnection group |
| Bronchial Suction group | Active comparator | The suction port of the bronchial blocker, and connected to -30 cm H2O of suction. Receives: Other: Bronchial Suction group |
What is being measured
The primary outcome is the main question the study is designed to answer.
time needed for lung collapse
measured from the institution of OLV to the time of total lung collapse
Measured: 3 min before one lung ventilation
Secondary outcomes (4)
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.
Measured: every 20 min intervals after one lung ventilation initiation
Overall surgeon satisfaction
Overall surgeon satisfaction with surgical conditions as assessed using a verbal analog scale (0 = unsatisfied to 10 = very satisfied)
Measured: 15 min after surgery
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
Measured: 5 min after reinflation of the surgical lung
Intraoperative hypoxemia
Intraoperative hypoxemia (SaO2 < 92%)
Measured: For 2 hours during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spontaneous PneumothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030795
- Sponsor's protocol ID
- Anesth-Dec13
- Status last verified
- Apr 2015
- First submitted
- 7 Jan 2014
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25564782
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Deflation With Arndt® Blocker During Video-Assisted Thoracoscopy: A Comparison of the Disconnection Technique With a Continuous Bronchial Suction
- ClinicalTrials.gov ID
- NCT02030795
- Acronym / sponsor ID
- Anesth-Dec13
- Conditions
- Spontaneous Pneumothorax
- Keywords
- Thoracic surgery, Arndt® blocker, lung deflation, Disconnection technique, Continuous suction, Elective video-assisted thoracoscopic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disconnection group | Active comparator | Other: Disconnection groupThe single lumen tube was disconnected from the ventilator for 60 s allowing the surgical lung to collapse. |
| Bronchial Suction group | Active comparator | Other: Bronchial Suction groupThe suction port of the bronchial blocker, and connected to -30 cm H2O of suction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical class (II-III)
- Need of one lung ventilation
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disconnection groupThe 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 | Other | Disconnection group |
| Bronchial Suction groupThe 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. | Other | Bronchial Suction group |
Primary outcome
time needed for lung collapse
Time frame: 3 min before one lung ventilation
measured from the institution of OLV to the time of total lung collapse
4 secondary outcomes
quality of lung collapse
Time frame: every 20 min intervals after one lung ventilation initiation
Overall surgeon satisfaction
Time frame: 15 min after surgery
Number of times that the fiberoptic bronchoscope required to assure proper position
Time frame: 5 min after reinflation of the surgical lung
Intraoperative hypoxemia
Time frame: For 2 hours during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
- Derived from this study: PubMed 25564782El-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disconnection group and Bronchial Suction group in people with Spontaneous Pneumothorax, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time needed for lung collapse (time frame: 3 min before one lung ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02030795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.