Trial document




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  DRKS00016887

Trial Description

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Title

The influence of perioperative volume strategy and ventilation on pulmonary function after robotic assisted laparoscopic prostatectomy (RALP)

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Trial Acronym

VoluVent study

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The planned VoluVent study will investigate the impact of ventilation and perioperative intravenous volume replacement during RALP on patient perioperative and postoperative oxygenation and ventilation.

Hypothesis of the VoluVent study:
The group of patients with pulmonary protective ventilation and restrictive volume administration perioperatively has better peri- and postoperative pulmonary function due to lower intraoperative ventilation volumes with higher PEEP levels and lower edema formation.

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Organizational Data

  •   DRKS00016887
  •   2019/03/07
  •   [---]*
  •   yes
  •   Approved
  •   18-1224-101, Ethikkommission an der Universität Regensburg
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Secondary IDs

  •   Z-2018-1112-5   (Zentrum für Klinische Studien des Universitätsklinikums Regensburg)
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
  •   H02.9 -  Disorder of eyelid, unspecified
  •   R06.0 -  Dyspnoea
  •   lung function peri- and postoperative
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Interventions/Observational Groups

  •   conventional (PEEP 5 cmH2O) ventilation versus lung-protective (best-PEEP) ventilation group:

    PEEP-Trail in the lung-protective ventilation group with determination of the best PEEP after intubation (based on blood gas analyzes and dynamic lung compliance)
  •   perioperative restrictive (10ml / kg predicted body weight crystalloids) versus liberal volume administration (20ml / kg predicted body weight crystalloids):
    Spirometry and weight control of study patients postoperatively
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, data analyst
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Measurement of lung volumes pre- and postoperatively by means of spirometry at four defined timepoints

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Secondary Outcome

- Registration of hemodynamic and pulmonary parameters perioperatively
- Weight measurement pre- and postoperative
- Blood gas analyzes perioperatively
- Acquisition of facial edema (chemosis) postoperatively

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/05/08
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

planned RALP in patients with prostate cancer

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Exclusion Criteria

- known pulmonary diseases (COPD, Asthma bronchiale)
- Rejection of study participation by the patient
- BMI> 40 kg / m²

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Addresses

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    • Caritas Krankenhaus St. Josef, Klinik für Anästhesiologie
    • Mr.  PD Dr.  Michael  Pawlik 
    • Landshuter Str. 65
    • 93053  Regensburg
    • Germany
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    • Universitätsklinikum Regensburg, Klinik für Anästhesiologie
    • Mr.  Dr.  Sebastian  Blecha 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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    • Caritas Krankenhaus St. Josef, Klinik für Anästhesiologie
    • Mr.  PD Dr.  Michael  Pawlik 
    • Landshuter Straße 65
    • 93053  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • Caritas Krankenhaus St. Josef, Klinik für Anästhesiologie
    • Mr.  PD Dr.  Michael  Pawlik 
    • Landshuter Str. 65
    • 93053  Regensburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.