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

Thoracic Diseases Clinical Trial

— DPEIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997072
• Other study ID #: SilesianMU-PVA1
• Status: Completed
• Phase: N/A
• First received: December 15, 2016
• Last updated: December 15, 2016
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Silesian University of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Older than 18

• Obtained written consent form to participate in research

• Patients qualified for rigid bronchoscopy procedure

Exclusion Criteria:

• Absence of the written consent to participate in research

• Undergoing urgent treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thoracic Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Silesian University of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes	No