Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Supported Mechanical Ventilation
NCT ID: NCT04141293
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-08-01
2021-11-01
Brief Summary
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Previous studies by the same research team confirmed that the alveolar recruitment maneuver improves oxygenation in patients with moderate-to-severe hypoxemic respiratory failure under pressure supported ventilation. Following recruitment maneuver, arterial oxygenation increased in 74 % of all patients. However, there is lack of information regarding the actual degree of changes in transpulmonary pressure and the consequent hemodynamic alterations.
The primary aim of the study is to evaluate precisely the transpulmonary pressure changes during recruitment in patients with severe hypoxemic respiratory failure ventilated in pressure support mode following insertion of a balloon-catheter into the esophagus. In the meantime, hemodynamic changes are monitored by PiCCO and transthoracic echocardiography, and lung field aeration by electric impedance tomography.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Eligible patients
alveolar recruitment
Alveolar recruitment is a procedure to re-expand collapsed lung regions with the transient increment in transpulmonary pressure.
Interventions
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alveolar recruitment
Alveolar recruitment is a procedure to re-expand collapsed lung regions with the transient increment in transpulmonary pressure.
Eligibility Criteria
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Inclusion Criteria
* pressure supported ventilation
* moderate-to-severe hypoxemic respiratory failure according to ARDS Berlin Criteria Moderate: 100 Hgmm ≤ PaO2/FiO2 ≤ 200 Hgmm, PEEP ≥ 5 cmH2O Severe: PaO2/FiO2 ≤ 100 Hgmm, PEEP ≥ 5 cmH2O
Exclusion Criteria
* pregnancy
* previous pulmonary resection, pulmonectomy
* clinically verified, end-stage COPD
* severe hemodynamic instability (i.e. refractory shock to vasopressors)
* severe emphysema and/or spontaneous pneumothorax in past medical history
* contraindications of a balloon-catheter (e.g. esophageal abscess, esophageal perforation, esophageal diverticulosis, esophagus tumor, esophagus varix, recent esophagus or gastric surgery, severe coagulopathy)
18 Years
ALL
No
Sponsors
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Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
OTHER_GOV
Responsible Party
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András Lovas
Head of Department
Locations
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University of Szeged, Department of Anesthesiology and Intensive Therapy
Szeged, Csongrád megye, Hungary
Countries
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References
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Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.
Lovas A, Nemeth MF, Trasy D, Molnar Z. Lung recruitment can improve oxygenation in patients ventilated in continuous positive airway pressure/pressure support mode. Front Med (Lausanne). 2015 Apr 21;2:25. doi: 10.3389/fmed.2015.00025. eCollection 2015.
Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014 Mar 6;370(10):980. doi: 10.1056/NEJMc1400293. No abstract available.
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
Other Identifiers
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101/2017-SZTE
Identifier Type: -
Identifier Source: org_study_id
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