Trial document




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  DRKS00005715

Trial Description

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Title

Comparison of respiratory mechanics, pulmonary ventilation and arterial oxygen partial pressure preserving the positive airway pressure during patient transport from induction room into the operating theatre.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

During spontaneous breathing chest wall muscles, the diaphragm and the vocal cords prevent alveoli from collapsing. After induction of anesthesia and muscle relaxation, the elastic restoring forces of the lung tissue predominate and thus lead to collapsing of the lungs after a short time. For this reason, a positive endexpiratory pressure (PEEP) is applied during general anesthesia in order to keep the lower respiratory tract open. The transfer of patients from the anesthesia induction room into the operating room, however, requires the temporary disconnection from the ventilator. Hence the intrapulmonary pressure drops to atmospheric pressure level across the endotracheal tube (ETT). As a consequence there may be atelectasis and decreased oxygen content in the arterial blood. In the present study the incidence of atelectasis during ongoing positive airway pressure is to be examined in comparison to the decrease in airway pressure to atmospheric pressure occurring after disconnection from the ventilator. For this purpose, the ETT will be extended using a conventional breathing hose (7 cm) permitting maintenance of the positive airway pressure during the disconnection of the ventilator by occlusion of this hose. Before induction of general anesthesia, patients will be allocated in three study groups (randomization). For the period of patient transport from the anesthesia room into the operating room, the pressure levels in the patients’ lungs will either be kept on atmospheric pressure level (usual procedure), on end expiratory pressure level or on end inspiratory pressure level. Before disconnection, during patient transport and after reconnection to the ventilator, the airway pressure, as well as lung ventilation by means of electrical impedance tomography (EIT) as well as oxygen concentration in the arterial blood based on a total of two blood gas analyzes will be measured. The duration of general anesthesia is not affected by this study.

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Brief Summary in Scientific Language

After induction of general anesthesia, the patient usually has to be transported from the anesthesia induction room to the operating room. This requires the disconnection from the ventilator and consequently leads to dropping of the airway pressure (Paw) to atmospheric pressure (atelectasis). Against this background, we hypothesize that continuous positive airway pressures during patient transport reduces the risk of atelectasis and keeps the arterial oxygen partial pressure constant. For this purpose, the endotracheal tube (ETT) is extended with a commercially available hose mount and the airway pressure sensor is placed between the ETT and the hose mount. By occlusion of the hose mount via a plastic clamp, the positive airway pressure can be maintained even during patient transport. A total of 45 lung healthy adult patients should be randomized and examined in three study groups each consisting of 15 patients. A control group with regular disconnection (Paw = 0 cm H2O ) is compared to a study group (1) with Paw at PEEP level ( max. 10 cm H2O) and to a study group (2) with Paw on inspiratory plateau pressure level (max 20 cm. H2O ). Randomization is achieved using a computer-generated randomization sequence. Before, during and after the disconnection from the ventilator Paw, regional lung ventilation evaluated by means of electrical impedance tomography (EIT) and arterial oxygen partial pressure in a blood gas sample are measured.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005715
  •   2014/05/05
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  •   yes
  •   Approved
  •   70/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Patients undergoing intraoperative ventilation
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Interventions/Observational Groups

  •   Patient transport from the anaesthesia induction room to the operating theatre without ETT occlusion with a plastic clamp. Airway pressure = atmospheric pressure during patient transport. Continuous measurement of airway pressure and regional ventilation. Measurement of arterial oxygen partial pressure before and after Patient transport. (control group)
  •   Patient transport from the anaesthesia induction room to the operating theatre with ETT occlusion with a plastic clamp. Airway pressure = positive endexpiratory pressure during patient transport. Continuous measurement of airway pressure and regional ventilation. Measurement of arterial oxygen partial pressure before and after Patient transport. (study group 1)


  •   Patient transport from the anaesthesia induction room to the operating theatre with ETT occlusion with a plastic clamp. Airway pressure = endinspiratory plateau pressure during patient transport. Continuous measurement of airway pressure and regional ventilation. Measurement of arterial oxygen partial pressure before and after Patient transport. (study group 2)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Continuous measured airway pressure (mainstream).

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Secondary Outcome

Continuous measured regional distribution of ventilation by means of electrical impedance tomography.
Arterial oxygen partial pressure measured by means of bloodgas samples before and after the transfer of the patient.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/09/30
  •   45
  •   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

adult, absence of pulmonary disease, elective operation in general anaesthesia, invasive blood pressure monitoring

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Exclusion Criteria

age<18 years, patients refusal, diagnosed lung disease, compromising cardiopulmonal disease, pregnancy, präoperative oxygenation disorder, emergency operation, overweight (BMI>50), heart pacemaker, heart defibrillator and other active implant, valvular heart disease, language barrier

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Addresses

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    • Klinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Freiburg
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Freiburg
    • Mr.  PD Dr.  Stefan  Schumann 
    • Hugstetter Str. 55
    • 79106  freiburg
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin
    • Mr.  Johannes  Spaeth 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Freiburg
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/03/25
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Trial Publications, Results and other Documents

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