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Thoracic DiseasesDPEITNCT02997072

Lungs Aeration Changes Examined by Impedance Tomography During High Frequency Jet Ventilation.

An observational study of Thoracic Diseases, run by Silesian University of Medicine.

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

The purpose of this study is attempt to establish optimum drive pressure of high frequency jet ventilation during rigid bronchoscopy to ensure good aeration of the lungs examined by electrical impedance tomography. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thoracic Diseases
How many people
30 participants
Where
No sites listed yet
Study dates
Jul 2014to Dec 2016
Phase
Observational
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

Study population: Group of 30 patients hospitalized in 1st Clinical Hospital in Zabrze that were qualified for planned thoracotomy or videothoracoscopy with the preceding rigid bronchoscopy procedure.

Who may be able to join

  • Older than 18
  • Obtained written consent form to participate in research
  • Patients qualified for rigid bronchoscopy procedure

Who cannot join

  • Absence of the written consent to participate in research
  • Undergoing urgent treatment

About this study

Official title: Assessment of Regional Lungs Aeration Changes Examined by Impedance Tomography, Depending on the Drive Pressure Applied During High Frequency Jet Ventilation.

The purpose of this study is attempt to establish optimum drive pressure of high frequency jet ventilation during rigid bronchoscopy to ensure good aeration of the lungs examined by electrical impedance tomography.

Read the detailed description

The study was performed in the Department of Anaesthesiology and Intensive Therapy in Zabrze.

After application of eligibility criteria 30 patients were enrolled in a prospective, observational study. Each patient received an information about the study and the consent form to carry out the measurement procedures was obtained. The data about sex, age, weight, height, comorbidities, BMI were collected.

Patients were given premedication, midazolam (Sopodorm, ICN Polfa Rzeszow, Poland; doses: weight 80kg - 7.5 mg; weight 80-100kg - 15mg) on hour before projected surgery.

Upon arrival to the operating room patient's basic monitoring was provided: ECG (3 leads), heart rate, noninvasive measurement of blood pressure (NIBP), and pulse oximetry. At the same time, a belt with electrodes was put on a patient to monitor impedance tomography, then an automatical record of the basic parameters of regional lung ventilation was turned on.

The medications used for induction of anesthesia: fentanyl (Fentanyl WZF, Polfa Warsaw, Poland) at a dose of 2 g /kg bw i.v., propofol (Diprivan, AstraZeneca, PolskaPlofed Polpharma Poland) at a dose of 2 mg / kg bw, i.v. and to carry out an intubation - cis-atracurium (Nimbex, GlaxoSmithKine, UK) at dose of 0.15 mg /kg bw i.v. During rigid bronchoscopy maintenance of general anesthesia was achieved through the supply of intravenous propofol at a dose of 10 - 6 mg/kg bw/h.The high frequency jet ventilation (HFJV) was performed with proper respirator (Universal Jet Ventilator Monsoon DeLuxe ACUTRONIC Switzerland), using following ventilation parameters: f = 160-200 breaths / min, FiO2 (fraction of inspired oxygen) = 1, the DP (drive pressure) = 1.5-2.5 Atm. Simultaneously, patients were monitored using a PulmoVista 500 Dräger device and aeration of the lungs examined by electrical impedance tomography were observed in a monitor.

During anesthesia, patients received hydration in the form of a 0.9% solution of Ringer's lactate at 4 ml/kg bw/h. In the event of bradycardia atropine (Atropine sulfuricum, Polfa Warsaw, Poland) at dose of 0.5 mg iv was given, in the event of a decrease in mean arterial pressure below 70 mmHg or 25% compared to the output pressure, ephedrine (Ephedrinum Hydrochloricum WZF, Polfa Warsaw, Poland) in fractionated doses of 5 mg iv (Max 25 mg) was given and in the case of the ineffectiveness of the proceedings dopamine infusion (Dopaminum Hydrochloricum WZF 4%, Polfa Warsaw, Poland) in the syringe pump titrated to maintain a mean arterial pressure above 70 mmHg.

Recovery from anesthesia took place at the recovery room after the removal of the anesthetics and muscle relaxants. If necessary, reverse the action of muscle relaxants was announced neostigmine (Polstygminum, Teva Pharmaceuticals Poland, Poland) at a dose of 0.5 - 2.5 mg i.v.

During anesthesia following parameters were monitored: ECG (3 leads), heart rate, noninvasive blood pressure (NIBP) every 3 minutes and arterial oxygen saturation measured by pulse oximetry.

Keywords
electrical impedance tomography, high frequency jet ventilation, drive pressure
Medical subject headings
Thoracic Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lung aeration corresponding to each layer of the lungs.

    The numerical values indicating the percentage of total increased resistance corresponding to each layer of the lungs (ROI - region of interests) that were collected in 15-seconds intervals.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2016 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02997072
Sponsor's protocol ID
SilesianMU-PVA1
Acronym
DPEIT
Status last verified
Dec 2016
First submitted
15 Dec 2016
Last updated
19 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bialka S, Copik M, Rybczyk K, Owczarek A, Jedrusik E, Czyzewski D, Filipowski M, Rivas E, Ruetzler K, Szarpak L, Misiolek H. Assessment of changes of regional ventilation distribution in the lung tissue depending on the driving pressure applied during high frequency jet ventilation. BMC Anesthesiol. 2018 Jul 31;18(1):101. doi: 10.1186/s12871-018-0552-2.

    PubMed 30064377

Questions about this trial

What is this clinical trial studying?

An observational study of Thoracic Diseases, run by Silesian University of Medicine.

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 3 inclusion and 2 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 19 Dec 2016. 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?

Lung aeration corresponding to each layer of the lungs. (time frame: 10 minutes). 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 NCT02997072, 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 19 Dec 2016; AzTrials last refreshed its copy on 3 Nov 2026.

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