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

Pulmonary Ventilation; Newborn, Abnormal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03326414
• Other study ID #: ANA-UKE-PV5538
• Status: Not yet recruiting
• Phase: N/A
• First received: August 28, 2017
• Last updated: October 25, 2017
• Start date: January 2018
• Est. completion date: June 2018

Study information

• Verified date: October 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Alexander März, MD
• Phone: +40 40 7410
• Email: a.maerz[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Ventilation; Newborn, Abnormal

Intervention

Procedure:
• Constant PEEP - low tidal volume
The respirator is set according to study protocol
• Constant PEEP - high tidal volume
The respirator is set according to study protocol
• constant tidal volume - low PEEP
The respirator is set according to study protocol
• constant tidal volume - high PEEP
The respirator is set according to study protocol

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Canet J, Sabaté 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. — View Citation

Ukere A, März A, Wodack KH, Trepte CJ, Haese A, Waldmann AD, Böhm 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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