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Clinical validation during anesthesia of the Dräger PulmoVista 500 monitor.

- candidate number11285
- NTR NumberNTR3333
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-mrt-2012
- Secondary IDs2012/035 MEC UZ Brussel
- Public TitleClinical validation during anesthesia of the Dräger PulmoVista 500 monitor.
- Scientific TitleClinical validation during anesthesia of the Dräger PulmoVista 500 monitor.
- hypothesisThe bedside efficacy of the Dräger PulmoVista 500 monitor in intensive care settings during mechanical ventilation is known. The present study will demonstrate its utility (if any) during anesthesia.
- Healt Condition(s) or Problem(s) studiedMechanical ventilation, Atelectasis, Anesthesia, One-lung ventliation, Airway devices, Positie
- Inclusion criteriaAdult patients scheduled for general surgery without major heart, liver or kidney disordes.
- Exclusion criteriaPatients < 18Y and patients with major heart, liver or kidney disorders.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-mrt-2012
- planned closingdate31-dec-2013
- Target number of participants160
- InterventionsMonitoring of lungs using the PulmoVista 500 lung monitor during anesthesia in different conditions:
1. Comparison of airway devices: Spontaneously breathing patients, ETT and general anesthesia, LM and general anesthesia, mask ventilation and general anesthesia, during epidural/spinal anesthesia;
2. During laparoscopic surgery in three classical positions – supine, Trendelenburg and reverse Trendelenburg;
3. During two and one-lung ventilation in the supine position with closed chest;
4. During High frequency jet ventilation versus one-lung ventilation.
- Primary outcomeOccurence of ateclestasis during anesthesia with different ventilatory modes and devices will be investigated and the best ventilatory device and method described.
- Secondary outcomeChanges of haemodynamics 20 % beyond baseline measurements, or hypoxia with hemoglobin oxygen saturation below 90 %will be reported.
- TimepointsBefore and after induction of anesthesia, during two and one-lung ventilation, during high frequency jet ventilation for bilateral thoracoscopy versus one-lung ventilation, in all cases before the start of the surgery.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Veerle Mossevelde, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Laszlo Szegedi
- Sponsor/Initiator Universitair Ziekenhuis Brussel
- Funding
(Source(s) of Monetary or Material Support)
Universitair Ziekenhuis Brussel
- PublicationsN/A
- Brief summaryThe study is designed to investigate the efficacy of the Drager PulmoVista 500 monitor in different conditions of ventilation, during anesthesia.
- Main changes (audit trail)
- RECORD6-mrt-2012 - 16-mrt-2012

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