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Clinical Trials/NCT03326414
NCT03326414
Unknown
Not Applicable

Influence of Different PEEP Levels and Different Tidal Volumes on Regional Pulmonary Function in Patients Undergoing Robot Assisted Prostatectomy Detected by Electrical Impedance Tomography

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country40 target enrollmentJanuary 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Ventilation; Newborn, Abnormal
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
40
Locations
1
Primary Endpoint
Change of "dependent silent spaces" (DSS) and "non-dependent silent spaces" (NSS)
Last Updated
8 years ago

Overview

Brief Summary

Mechanical ventilation is indispensable for most of surgical interventions but can induce lung injury even in pulmonary healthy patients. This can lead to postoperative pulmonary complications. These adverse effects could be prevented by a better monitoring of intraoperative lung function. Electrical impedance tomography is able to visualize aeration within the lung in real time.

The planned study investigates the influence of different levels of positive endexspiratory pressure and different tidal volumes on the aeration.

Detailed Description

Available perioperative parameters to set mechanical ventilation parameters represent only global lung function. But to reduce postoperative pulmonary complications induced by mechanical ventilation a better monitoring of intraoperative lung function seems to be crucial, that provides more regional information of lung collapse or over distention. By application of small currents via electrodes around the thorax and measuring of the resultant resistance the electrical impedance tomography (EIT) can determine the level of aeration of the lung in a cross sectional plane. The EIT device used in this study calculates the percentage of the investigated lung area that can be defined as over distended or collapsed respectively. In these sections the change of resistance within a respiration cycle is reduced compared to well ventilated areas are therefore called silent spaces. Silent spaces located ventral are termed non-dependent (NSS) and silent spaces located dorsal are termed dependent (DSS). Based on this information the clinician is able to set the respirator in a more lung protective manor. To better understand the influence of positive endexspiratory pressure (PEEP) and tidal volume (Vt) on reginal lung function we are going to carry out the presented study. 40 patients undergoing robot assisted prostatectomy should be enrolled in a study that consists of two phases. In the first phase 20 patients are ventilated with constant PEEP (10mbar) and in ten patients each the Vt is set to 5 or 12ml/kg ideal body weight. In the second phase in further 20 patients the Vt is set to 8ml/ kg ideal bodyweight and the PEEP is 3 or 12mbar in one half of the patients. Under the different ventilation settings the NSS and DSS, the oxygenation index and lung compliance will be investigated.

Registry
clinicaltrials.gov
Start Date
January 2018
End Date
June 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • over 18 years of age
  • scheduled for robot assisted prostate ectomy

Exclusion Criteria

  • body mass index \>35 kg/m²
  • chronic obstructive lung disease (GOLD III or IV)
  • obstructive sleep apnoe syndrome
  • planned or unplanned admission to intensive care unit for prolonged ventilation
  • mechanical ventialtion within the last 30 days
  • lung operation in the past
  • other lung disease that impairs activity

Outcomes

Primary Outcomes

Change of "dependent silent spaces" (DSS) and "non-dependent silent spaces" (NSS)

Time Frame: measurement of DSS and NSS are carried out prior to induction of anesthesia, 10 minutes after induction, 30 minutes after after installation of capnoperitoneum, 10 minutes after skin closure, 15 minutes after arrival at the PACU

The change of silent spaces under different ventilator settings during surgery is investigated.

Secondary Outcomes

  • Oxygenation index(prior to induction of anesthesia, 10 minutes after induction, 30 minutes after installation of capnoperitoneum, 10 minutes after skin closure, 15 minutes after arrival at the PACU)
  • complinace of the respiratory system(10 minutes after induction, 30 minutes after capnoperitoneum applied, 10 minutes after skin closure)

Study Sites (1)

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