Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position

Mechanical Ventilation Clinical Trial

Official title:

Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704038
• Other study ID #: 2018EIT
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: April 2019
• Source: University Hospital Dubrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Goal of this study is to determine optimal PEEP levels for patients undergoing surgery in lateral decubitus position. Patients will be randomized into 3 groups - PEEP 0, 5 and 10 mbar. Endotracheal anesthesia will be conducted with propofol, fentanyl, rocuronium and sevoflurane/O2/air gas mixture.

Patients with preexisting lung disease, organ transplants and disseminated malignant disease will be excluded.

Demographic data - age, weight, height, ASA status, smoking history will be recorded. EIT measured parameters - tidal variation ratio of nondependent and dependent lung, regional end-tidal and end-expiratory lung impedances as well as horizontal and vertical centers of ventilation will be recorded and calculated at 3 time points - before anesthesia induction, 5 minutes after lateral positioning of the patient and 90 minutes after lateral positioning. ABGs will be sampled to calculate aA gradient and Horovitz quotient at those time points as well as measured hemodynamic parameters (HR, BP, CI, SVI).

Primary endpoints for the study are nondependent/dependent tidal variation ratios measured at predefined time points and changes in ABGs. Secondary endpoints are number of postoperative pulmonary complications (defined as new onset of pneumonia during 28 days of followup), length of hospital stay and changes in hemodynamic parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled for nephrectomy, adrenalectomy or urterotomy surgery which will be performed in lateral decubitus position

• signed informed consent form

Exclusion Criteria:

• preexisting moderate to severe obstructive (GOLD score > 1) or restrictive lung disease (FVC < 85%)

• history of organ transplant

• disseminated malignant disease

• pregnancy

Related Conditions & MeSH terms

• Bioelectrical Impedance
• Mechanical Ventilation

Intervention

Procedure:
• PEEP level
Patients will have variable PEEP levels and will be monitored

Locations

Country	Name	City	State
Croatia	University Hospital Dubrava	Zagreb	Grad Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of nondependent / dependent tidal variation	Measured by EIT	Baseline, 10 and 90 minutes post lateral positioning
Secondary	Change of a-A gradient	Measured by ABG analysis	Baseline, 10 and 90 minutes post lateral positioning
Secondary	Duration of hospital stay	Between groups	Up to 28 days