An interventional study of Constant PEEP - low tidal volume and Constant PEEP - high tidal volume in Pulmonary Ventilation; Newborn, Abnormal, sponsored by Universitätsklinikum Hamburg-Eppendorf. Status unknown at 1 site in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-31.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
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.
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.
67 studies on the registry are indexed under Antisocial Personality Disorder; 10 are open to participants now.
This study's planned enrollment of 40 is below the median of 140 across 43 interventional studies indexed under Antisocial Personality Disorder.
Browse Antisocial Personality Disorder studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PEEP is 10mbar, tidal volume is set to 4-5ml/kg IBW
Procedure: Constant PEEP - low tidal volume
PEEP is 10mbar, tidal volume is set to 8-10ml/kg IBW
Procedure: Constant PEEP - high tidal volume
tidal volume is 8ml/kg IBW, PEEP is set to 3mbar
Procedure: constant tidal volume - low 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
The respirator is set according to study protocol
The respirator is set according to study protocol
The respirator is set according to study protocol
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.
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
Oxygenation index
The partial pressure of oxygen is determined at every point of measurement and the value is devided by inspiratory oxygen fraction
Time frame: 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
Time frame: 10 minutes after induction, 30 minutes after capnoperitoneum applied, 10 minutes after skin closure
postoperative pulmonary complicaitons
postoperative complications like pneumonia, reintubation and need for non-invasive ventilation are recorded
Time frame: postoperative pulmonary complications apearing within 7 days after surgery
Plan to share: Undecided — It is not planned to share data with other researchers except data published within an article.
Start is estimated for Jan 2018; primary completion for Apr 2018, 3 months later.
Of 25 interventional studies with no phase under Antisocial Personality Disorder, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's planned 3 months is below that.
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