Trial document




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  DRKS00005692

Trial Description

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Title

Determination of respiratory mechanics, arterial oxygenation and functional lung ventilation under a prospective change of the end-expiratory pressure in healthy, intubated and mechanically ventilated patients in the prone position.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study includes patients who undergo spine surgery and general anesthesia in the prone position. It is a known fact that the conditions of the lungs lung specific characteristics differ significantly under controlled mechanical ventilation depending on either the prone or supine position respectively. However, there are few studies on the adjustment of ventilation parameters in lung- healthy patients in the prone position exist. The end expiratory pressure (PEEP) is of particular importance. PEEP can prevent periodic lung collapse and reopening in the small airways and alveoli (atelectasis) and thus can alter the gas exchanging surface of the lungs. In the present study, lung healthy adult patients will be ventilated at three different PEEP levels in the prone position. On any PEEP level, measurement of the respiratory mechanics, oxygen partial pressure in human blood and the distribution of lung ventilation (by means of electrical impedance tomography (EIT)) is carried out. The aim of the study is to identify the optimal PEEP level for ventilation in the prone position and to evaluate the relation of PEEP and individual patient parameters (eg. body weight, BMI). In the future, mechanical ventilation in the prone position with optimized PEEP levels can potentially reduce the risk of atelectasis and thereby reduce the risk of pulmonary complications after surgery.

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Brief Summary in Scientific Language

The aim of the present study is to measure the airway pressure and flow, arterial oxygen partial pressure (PaO2) and the regional lung ventilation via electrical impedance tomography (EIT) at different end-expiratory pressure (PEEP) levels during volume controlled ventilation (VCV) in prone position. For this purpose 60 lung healthy patients undergoing general anesthesia and arterial blood pressure monitoring, are examined during an elective neurosurgical operation on the lumbar spine. In the prone position, a recruitment maneuver is performed for the expansion of the collapsed lung areas. Subsequently, the lungs will be ventilated at 6, 9 and 12 cmH2O PEEP level each for at least 20 minutes (randomized order). At the end of the breathing intervals airway pressure and flow, PaO2 and EIT will be recorded for about 5 minutes. We hypothesize that the increase in PEEP level during ventilation of healthy adult patients in the prone position, reduces the risk of atelectasis and improves the patients’ arterial oxygenation.

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Organizational Data

  •   DRKS00005692
  •   2014/02/26
  •   [---]*
  •   yes
  •   Approved
  •   14/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   intraoperative, controlled ventilation
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Interventions/Observational Groups

  •   Patients with perioperative, controlled ventilation in prone position will be ventilated at 6 cmH2O PEEP level. After 15 minutes of ventilation the following parameters will be measured: (1) airway pressure and flow, (2) arterial oxygen partial pressure (3) pulmonary ventilation distribution, using electrical impedance tomography (EIT)
  •   Patients with perioperative, controlled ventilation in prone position will be ventilated at 9 cmH2O PEEP level. After 15 minutes of ventilation the following parameters will be measured: (1) airway pressure and flow, (2) arterial oxygen partial pressure (3) pulmonary ventilation distribution, using electrical impedance tomography (EIT)
  •   Patients with perioperative, controlled ventilation in prone position will be ventilated at 12 cmH2O PEEP level. After 15 minutes of ventilation the following parameters will be measured: (1) airway pressure and flow, (2) arterial oxygen partial pressure (3) pulmonary ventilation distribution, using electrical impedance tomography (EIT)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Calculation of the respiratory system compliance using airway pressure and tidal volume (measured by volume flow) at each PEEP level

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Secondary Outcome

arterial oxygen partial pressure, measured by arterial blood gas sample, one measurement at each PEEP level;
functional regional lung ventilation, measured by means of the electrical impedance tomography, one measurement at each PEEP level (5 min.)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/03/03
  •   48
  •   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

controlled ventialtion, prone position, arterial blood pressure monitoring

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Exclusion Criteria

age<18 years, patients refusal, diagnosed lung disease, compromising cardiopulmonal disease, pregnancy, intraoperative 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
  •   2014/09/17
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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.