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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Ventilation; Newborn, Abnormal
• Intervention / Treatment: Procedure: Constant PEEP - low tidal volume; Procedure: Constant PEEP - high tidal volume; Procedure: constant tidal volume - low PEEP; Procedure: constant tidal volume - high PEEP

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander März, MD; Phone Number: 54477 +40 40 7410; Email: a.maerz@uke.de
• Study Contact Backup: Name: Daniel A Reuter, MD; Phone Number: 54477 +49 40 7410; Email: dreuter@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Constant PEEP - low tidal volume; PEEP is 10mbar, tidal volume is set to 4-5ml/kg IBW	Procedure: Constant PEEP - low tidal volume; The respirator is set according to study protocol
OTHER: Constant PEEP - high tidal volume; PEEP is 10mbar, tidal volume is set to 8-10ml/kg IBW	Procedure: Constant PEEP - high tidal volume; The respirator is set according to study protocol
OTHER: constant tidal volume - low PEEP; tidal volume is 8ml/kg IBW, PEEP is set to 3mbar	Procedure: constant tidal volume - low PEEP; The respirator is set according to study protocol
OTHER: constant tidal volume - high PEEP; tidal volume is 8ml/kg IBW, PEEP is set to 12mbar	Procedure: constant tidal volume - high PEEP; The respirator is set according to study protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of "dependent silent spaces" (DSS) and "non-dependent silent spaces" (NSS)	The change of silent spaces under different ventilator settings during surgery is investigated.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation index	The partial pressure of oxygen is determined at every point of measurement and the value is devided by inspiratory oxygen fraction	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	The compliance of the respiratory system (ml/mbar) is mesured by the respirator during mechanical ventilation	10 minutes after induction, 30 minutes after capnoperitoneum applied, 10 minutes after skin closure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pulmonary complicaitons	postoperative complications like pneumonia, reintubation and need for non-invasive ventilation are recorded	postoperative pulmonary complications apearing within 7 days after surgery

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Study Director: Daniel A Reuter, MD, Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Hospital Hamburg-Eppendorf, Germany

Publications and helpful links

General Publications

• Canet J, Sabate S, Mazo V, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P; PERISCOPE group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223.
• Ukere A, Marz A, Wodack KH, Trepte CJ, Haese A, Waldmann AD, Bohm SH, Reuter DA. Perioperative assessment of regional ventilation during changing body positions and ventilation conditions by electrical impedance tomography. Br J Anaesth. 2016 Aug;117(2):228-35. doi: 10.1093/bja/aew188.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): April 1, 2018
• Study Completion (ANTICIPATED): June 1, 2018

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (ACTUAL): October 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ANA-UKE-PV5538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not planned to share data with other researchers except data published within an article.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No