AnesthesiaNCT02786862
A Unique Device for Independent Lung Ventilation
A study testing independent ventilation in people with Anesthesia, run by Medical University of Lublin.
Trial summary
Adequate blood oxygenation and ventilation/perfusion matching should be the main goal of anaesthetic and intensive care management. At present, the sole method of improving gas exchange restricted by ventilation/perfusion mismatching is independent ventilation with two ventilators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- independent ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Feb 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I and II patients who underwent elective thoracic surgery under general anaesthesia, with double lumen tube intubation and one lung ventilation during surgical procedure.
Who cannot join
- All patients with asthma or chronic obstructive pulmonary disease, history of thoracotomy, assessed as ASA III, with difficult airway conditions, kyphoscoliosis or other alterations of chest wall or severe obesity were excluded
About this study
Official title: 1:1 Proportion Ventilation With a Unique Device for Independent Lung Ventilation Using a Double-Lumen Tube in the Supine and Lateral Decubitus Positions. A Pilot Study
Adequate blood oxygenation and ventilation/perfusion matching should be the main goal of anaesthetic and intensive care management. At present, the sole method of improving gas exchange restricted by ventilation/perfusion mismatching is independent ventilation with two ventilators. Recently, however, a unique device has been developed, enabling ventilation of independent lungs in 1:1, 2:1, 3:1, and 5:1 proportions. The main goal of the study was to evaluate the device's utility, precision and impact on biomechanical lung parameters during thoracic surgery under general anaesthesia with double lumen tube intubation. Secondly- to measure the gas distribution in supine and lateral decubitus position.
Read the detailed description
Anaesthetic management:
One hour before thoracic surgery, the patient-subjects received diazepam 0.15 mg kg-1 as premedication. After arriving at the operating theatre, standard monitoring system practices was applied, including heart rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), and pulse oximetry (SpO2). Moreover, an intra-vein cannula was placed, and the infusion of multi-electrolytic fluid 5-10 ml kg-1 h-1 was started. After pre-oxygenation, atropine 0.5 mg and fentanyl 3 µg kg-1 were given, and the induction of anaesthesia with thiopentone 5-7 mg kg-1 was started. Suxamethonium was administered for neuromuscular blockade, and bronchial intubation with a Robertshow double lumen tube was performed. The left bronchus was intubated for right lung surgery, and the right bronchus was intubated for left lung surgery. Tube placement was checked via auscultation and fiberscope. Anaesthesia was maintained with sevoflurane, additional fentanyl doses were used if needed, and neuromuscular blockade was obtained with vecuronium 0.1 mg kg-1. Additionally, 0.1 mg kg-1 dose of morphine was given subcutaneously for postoperative pain control. Patients were also ventilated with O2 (oxygen) and AIR (air) mixture, using the following settings: volume control intermittent positive pressure ventilation, FiO2 (oxygen fraction) 0.4, Vt (tidal volume) 6-10 ml/kg, and f (frequency) 12-15 /min. Furthermore, end tidal CO2 (carbon dioxide) was monitored due to normocapnia maintenance (4.0-5.3 kPa). At the end of surgery, intercostal blockade was brought about with 0.5% bupivacaine, with 5 ml for each nerve. Finally, the neuromuscular blockade was reversed with neostigmine 0.04 mg kg-1 and with atropine 0.01 mg kg-1.
After anaesthesia stabilisation, the unique control system was used, called the 'tidal volume divider'. This device was placed between the anaesthetic machine and the double lumen tube of the patient. This control system enables conventional ventilation (without any intervention from the control system, as the settings are defined on the ventilator), as well as independent ventilation with division of the tidal volume between the lungs in proportions of 1:1, 2:1, 3:1, and 5:1. It also enables PEEP (selective positive end-expiratory pressure) application to each lung. With independent ventilation, settings such as frequency, tidal volume and inspiration time are defined by ventilator, and this system only controls the direction of tidal volume to each lung (as the control system is a flow divider) by using a differential pneumatic resistor. It also enables dependent and non-dependent lung ventilation in the lateral decubitus positions. Furthermore, the system monitors the expired volume, airway pressure and dynamic compliance of each lung. This device was described and tested on mechanical lung models with a variety of lung model mechanics (compliance, resistance) and ventilation parameters (frequency, tidal volume). It was also tested clinically for its safety during our previous study. The system was invented, developed and patented by a group of Polish engineers from the Nałęcz Institute of Biocybernetics and Biomedical Engineering, the Polish Academy of Sciences, Poland.
- Conditions
- Anesthesia
- Being tested
- independent ventilation
- Keywords
- mechanical ventilation, independent ventilation, ventilation/perfusion mismatch, thoracic anesthesia
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
independent ventilationOther
comparison conventional and independent 1:1 ventilation
| Study group | Role | What they receive |
|---|---|---|
| Ventilation | Experimental | Measurements were made for conventional and independent at 1:1 proportion ventilation in supine position; then independent ventilation was discontinued and patient was moved to right or left decubitus position due to left or right lung surgery. Then were made measurements for conventional anaesthetic practices and followed independent at 1:1, 2:1, 3:1, 5:1 proportions ventilation routines. Constantly were monitored expired volume, peak respiratory pressure, dynamic compliance separately for each lung. Measurements covered also hemodynamic (MAP, HR) and oxygenation (SpO2). These attributes were documented at each point of the study. Subsequently, the control system was disconnected and performed typical anaesthetic procedures for thoracic surgery with a one-lung ventilation procedure. Receives: Other: independent ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume distribution during conventional and independent in 1:1 proportion ventilation in supine, left and right decubitus positions.
tidal volume
Measured: up to 12 months
Secondary outcomes (2)
Peak respiratory pressure measuring during conventional and independent in 1:1 proportion ventilation in supine, left and right decubitus positions.
peak respiratory pressure
Measured: up to 12 months
Dynamic compliance measuring during conventional and independent in 1:1 proportion ventilation in supine, left and right decubitus positions.
dynamic compliance
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Slawomir Sawulski, M.D., Ph.D., Principal investigator, Medical University of Lublin, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786862
- Sponsor's protocol ID
- MULublin
- Status last verified
- Jul 2018
- First submitted
- 11 Apr 2016
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Row data will be attached as supplementary files during publication process
Publications
Darowski M, Englisz M. Artificial ventilation of the lungs for emergencies. Front Med Biol Eng. 2000;10(3):177-83. doi: 10.1163/15685570052062576.
PubMed 11014679Sawulski S, Nestorowicz A, Sawicki M, Kowalczyk M, Ston M. [Independent lung ventilation during general anaesthesia--preliminary report]. Anestezjol Intens Ter. 2010 Jan-Mar;42(1):6-10. Polish.
PubMed 20608207
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1:1 Proportion Ventilation With a Unique Device for Independent Lung Ventilation Using a Double-Lumen Tube in the Supine and Lateral Decubitus Positions. A Pilot Study
- ClinicalTrials.gov ID
- NCT02786862
- Acronym / sponsor ID
- MULublin
- Conditions
- Anesthesia
- Keywords
- mechanical ventilation, independent ventilation, ventilation/perfusion mismatch, thoracic anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 Jun 2016 (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.
Adequate blood oxygenation and ventilation/perfusion matching should be the main goal of anaesthetic and intensive care management. At present, the sole method of improving gas exchange restricted by ventilation/perfusion mismatching is independent ventilation with two ventilators. Recently, however, a unique device has been developed, enabling ventilation of independent lungs in 1:1, 2:1, 3:1, and 5:1 proportions. The main goal of the study was to evaluate the device's utility, precision and impact on biomechanical lung parameters during thoracic surgery under general anaesthesia with double lumen tube intubation. Secondly- to measure the gas distribution in supine and lateral decubitus position.
Detailed description
Anaesthetic management:
One hour before thoracic surgery, the patient-subjects received diazepam 0.15 mg kg-1 as premedication. After arriving at the operating theatre, standard monitoring system practices was applied, including heart rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), and pulse oximetry (SpO2). Moreover, an intra-vein cannula was placed, and the infusion of multi-electrolytic fluid 5-10 ml kg-1 h-1 was started. After pre-oxygenation, atropine 0.5 mg and fentanyl 3 µg kg-1 were given, and the induction of anaesthesia with thiopentone 5-7 mg kg-1 was started. Suxamethonium was administered for neuromuscular blockade, and bronchial intubation with a Robertshow double lumen tube was performed. The left bronchus was intubated for right lung surgery, and the right bronchus was intubated for left lung surgery. Tube placement was checked via auscultation and fiberscope. Anaesthesia was maintained with sevoflurane, additional fentanyl doses were used if needed, and neuromuscular blockade was obtained with vecuronium 0.1 mg kg-1. Additionally, 0.1 mg kg-1 dose of morphine was given subcutaneously for postoperative pain control. Patients were also ventilated with O2 (oxygen) and AIR (air) mixture, using the following settings: volume control intermittent positive pressure ventilation, FiO2 (oxygen fraction) 0.4, Vt (tidal volume) 6-10 ml/kg, and f (frequency) 12-15 /min. Furthermore, end tidal CO2 (carbon dioxide) was monitored due to normocapnia maintenance (4.0-5.3 kPa). At the end of surgery, intercostal blockade was brought about with 0.5% bupivacaine, with 5 ml for each nerve. Finally, the neuromuscular blockade was reversed with neostigmine 0.04 mg kg-1 and with atropine 0.01 mg kg-1.
After anaesthesia stabilisation, the unique control system was used, called the 'tidal volume divider'. This device was placed between the anaesthetic machine and the double lumen tube of the patient. This control system enables conventional ventilation (without any intervention from the control system, as the settings are defined on the ventilator), as well as independent ventilation with division of the tidal volume between the lungs in proportions of 1:1, 2:1, 3:1, and 5:1. It also enables PEEP (selective positive end-expiratory pressure) application to each lung. With independent ventilation, settings such as frequency, tidal volume and inspiration time are defined by ventilator, and this system only controls the direction of tidal volume to each lung (as the control system is a flow divider) by using a differential pneumatic resistor. It also enables dependent and non-dependent lung ventilation in the lateral decubitus positions. Furthermore, the system monitors the expired volume, airway pressure and dynamic compliance of each lung. This device was described and tested on mechanical lung models with a variety of lung model mechanics (compliance, resistance) and ventilation parameters (frequency, tidal volume). It was also tested clinically for its safety during our previous study. The system was invented, developed and patented by a group of Polish engineers from the Nałęcz Institute of Biocybernetics and Biomedical Engineering, the Polish Academy of Sciences, Poland.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventilation | Experimental | Other: independent ventilationMeasurements were made for conventional and independent at 1:1 proportion ventilation in supine position; then independent ventilation was discontinued and patient was moved to right or left decubitus position due to left or right lung surgery. Then were made measurements for conventional anaesthetic practices and followed independent at 1:1, 2:1, 3:1, 5:1 proportions ventilation routines. Constantly were monitored expired volume, peak respiratory pressure, dynamic compliance separately for each lung. Measurements covered also hemodynamic (MAP, HR) and oxygenation (SpO2). These attributes were documented at each point of the study. Subsequently, the control system was disconnected and performed typical anaesthetic procedures for thoracic surgery with a one-lung ventilation procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I and II patients who underwent elective thoracic surgery under general anaesthesia, with double lumen tube intubation and one lung ventilation during surgical procedure.
Key exclusion criteria (1 listed)
- All patients with asthma or chronic obstructive pulmonary disease, history of thoracotomy, assessed as ASA III, with difficult airway conditions, kyphoscoliosis or other alterations of chest wall or severe obesity were excluded
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 |
|---|---|---|
| independent ventilationcomparison conventional and independent 1:1 ventilation | Other | Ventilation |
Primary outcome
Tidal volume distribution during conventional and independent in 1:1 proportion ventilation in supine, left and right decubitus positions.
Time frame: up to 12 months
tidal volume
2 secondary outcomes
Peak respiratory pressure measuring during conventional and independent in 1:1 proportion ventilation in supine, left and right decubitus positions.
Time frame: up to 12 months
Dynamic compliance measuring during conventional and independent in 1:1 proportion ventilation in supine, left and right decubitus positions.
Time frame: up to 12 months
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 12 Jul 2018.
- Background: PubMed 11014679Darowski M, Englisz M. Artificial ventilation of the lungs for emergencies. Front Med Biol Eng. 2000;10(3):177-83. doi: 10.1163/15685570052062576.
- Background: PubMed 20608207Sawulski S, Nestorowicz A, Sawicki M, Kowalczyk M, Ston M. [Independent lung ventilation during general anaesthesia--preliminary report]. Anestezjol Intens Ter. 2010 Jan-Mar;42(1):6-10. Polish.
- Individual participant dataSharing planned: Yes. Row data will be attached as supplementary files during publication process
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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.
Slawomir Sawulski, M.D., Ph.D. principal investigator
Medical University of Lublin, Poland
Questions about this trial
What is this clinical trial studying?
A study testing independent ventilation in people with Anesthesia, run by Medical University of Lublin.
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 1 inclusion and 1 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 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Tidal volume distribution during conventional and independent in 1:1 proportion ventilation in supine, left and right decubitus positions. (time frame: up to 12 months). 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 NCT02786862, which also lists 2 linked publications.
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 12 Jul 2018; AzTrials last refreshed its copy on 30 Oct 2026.