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AnesthesiaNCT02786862

A Unique Device for Independent Lung Ventilation

A study testing independent ventilation in people with Anesthesia, run by Medical University of Lublin.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 groups in NCT02786862
Study groupRoleWhat they receive
VentilationExperimentalMeasurements 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted1 Jun 2016 (estimated)
  2. Study startMar 2009
  3. Primary completionSep 2009
  4. Study completionFeb 2010

Resources

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)
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 11014679
  • Sawulski 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

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.

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