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Influence of Different PEEP Levels and Tidal Volumes on Regional Lung Function

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03326414
Enrollment
40
Registered
2017-10-31
Start date
2018-01-31
Completion date
2018-06-30
Last updated
2017-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Ventilation; Newborn, Abnormal

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.

Interventions

PROCEDUREConstant PEEP - low tidal volume

The respirator is set according to study protocol

PROCEDUREConstant PEEP - high tidal volume

The respirator is set according to study protocol

PROCEDUREconstant tidal volume - low PEEP

The respirator is set according to study protocol

PROCEDUREconstant tidal volume - high PEEP

The respirator is set according to study protocol

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

40 patients are to be investigated during the project. In phase one 20 patients are ventilated with constant PEEP of 10mbar and the tidal volume is set to 4-5ml/kg IBW or 8-10ml/kg IBW respectively. In phase two further 20 patients are ventilated with a constant tidal volume of 8ml/kg IBW and the PEEP is set to 3mbar or 12mbar respectively.

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of dependent silent spaces (DSS) and non-dependent silent spaces (NSS)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 PACUThe change of silent spaces under different ventilator settings during surgery is investigated.

Secondary

MeasureTime frameDescription
Oxygenation indexprior 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 PACUThe partial pressure of oxygen is determined at every point of measurement and the value is devided by inspiratory oxygen fraction
complinace of the respiratory system10 minutes after induction, 30 minutes after capnoperitoneum applied, 10 minutes after skin closureThe compliance of the respiratory system (ml/mbar) is mesured by the respirator during mechanical ventilation

Other

MeasureTime frameDescription
postoperative pulmonary complicaitonspostoperative pulmonary complications apearing within 7 days after surgerypostoperative complications like pneumonia, reintubation and need for non-invasive ventilation are recorded

Countries

Germany

Contacts

Primary ContactAlexander März, MD
a.maerz@uke.de+40 40 7410
Backup ContactDaniel A Reuter, MD
dreuter@uke.de+49 40 7410

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026