Trial document




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  DRKS00017495

Trial Description

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Title

Spontaneous breathing with a Flow Limiter in obese patients after general anaesthesia

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Trial Acronym

FloLiPo

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URL of the Trial

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Brief Summary in Lay Language

Controlling the expiration is more and more part of intensive clinical and experimental investigations. After the develpoment of the Flow-controlled expiration (FLEX), the research group for Clinical Respiratory Physiology (University Medical Center Freiburg, Germany) developed the Flow Limiter. The Flow Limiter is a passive tool to modulate expiratory air flow during spontaneous breathing and ventilation. The Flow Limiter consist of a plastic tube (polysulphone), a valve plate inside this tube (glass fiber mesh and epoxy resin) and two metal screws located on the outside of the tube. Depending on the air flow, the valve plate regulates the expiratory air flow dynamically. The two metal screws allows to adapt the pretension and the maximum occlusion of the valve plate and thus to adjust the Flow Limiter individually. The primary aim of this clinical trial is to investigate the effects of postoperative breathing exercise utilizing a Flow Limiter in obese patients after bariatric surgery under general anesthesia.

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Brief Summary in Scientific Language

The effect of obesity on the postoperative pulmonary recovery and the incidence of postoperative pulmonary complications is still under constant debate (1,2). Experimental data from animal studies suggest that a decelerated decrease in intrapulmonary air during expiration improves the homogeneity of air distribution (3,4). To enable a dynamic reduction of expiratory flow, we build a Flow Limiter. This is a passive instrument that is able to decrease expiratory air flow during spontaneous breathing and ventilation without external sensors and electricity.
In this parallel arm randomized controlled clinical trial, we would like to investigate the influence of postoperative breathing exercise with a Flow Limiter in obese patients on the postoperative pulmonary recovery. Therefore, patients will be randomized with an allocation ratio of 1:1 in a control and an intervention group. After standardized general anesthesia, patients will either breath spontaneously without (control) and with (intervention) the Flow Limiter connected to their face mask. During the study protocol, we will measure respiratory, hemodynamic and further clinical parameters.
To detect postoperative pulmonary complications (e.g. pneumonia, ARDS, hypoxemia) a follow-up will be performed on the 3. postoperative day.

(1): Shimizu et al.: Influence of visceral obesity for postoperative pulmonary complications after pancreaticoduodenectomy. J Gastrointest Surg 2011; 8: 1401-1410.
(2): Bamgbade et al.: Postoperative complications in obese and nonobese patients. World J Surg 2007; 31: 556-560.
(3): Schumann et al.: Determination of respiratory system mechanics during inspiration and expiration by FLow-controlled EXpiration (FLEX): a pilot study in anesthetized pigs. Minerva anestesiologica 2014;80:19–28.
(4): Schmidt et al.: Improved lung recruitment and oxygenation during mandatory ventilation with the new Expiratory Ventilation Assistance – a controlled interventional trial in healthy pigs. Eur J Anaesth 2018 Oct;35(10):736-744.

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Organizational Data

  •   DRKS00017495
  •   2019/07/08
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  •   yes
  •   Approved
  •   4019, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1236-3056 
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Health Condition or Problem studied

  •   J96.0 -  Acute respiratory failure
  •   E66.0 -  Obesity due to excess calories
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Interventions/Observational Groups

  •   Control group (spontaneous breathing without Flow Limiter)
  •   Intervention group (spontaneous breathing with Flow Limiter)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Postoperative oxygen saturation (pulse oximetry).

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Secondary Outcome

Incidence of postoperative pulmonary complications (radiologic, laborchemistry, microbiological examinations), respiratory and hemodynamic variables, blood gas test

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2019/07/23
  •   64
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Age ≥ 18 years, elective surgery in general anesthesia, physical status according to the ASA I-III, written informed consent, BMI > 30 kg/m.^-2

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Exclusion Criteria

Age < 18 years, COPD (GOLD 3, clinical presentation), pregnancy, emergency procedure, rejection of participation

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Addresses

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    • Department of Anesthesiology and Critical Care University Medical Center Freiburg
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Department of Anesthesiology and Critical Care University Medical Center Freiburg
    • Mr.  Dr.  Jonas  Weber 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Department of Anesthesiology and Critical Care University Medical Center Freiburg
    • Mr.  Dr.  Jonas  Weber 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting planned
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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.