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The effect of Continuous Positive Airway Pressure (CPAP) on the collapsed lung during single-lung-ventilation in patients undergoing robot-assisted thoracoscopic esophageal reseection: pulmonary complications, local and systemic cytokine production.


- candidate number2044
- NTR NumberNTR645
- ISRCTNISRCTN61458115
- Date ISRCTN created28-apr-2006
- date ISRCTN requested25-apr-2006
- Date Registered NTR28-mrt-2006
- Secondary IDsN/A 
- Public TitleThe effect of Continuous Positive Airway Pressure (CPAP) on the collapsed lung during single-lung-ventilation in patients undergoing robot-assisted thoracoscopic esophageal reseection: pulmonary complications, local and systemic cytokine production.
- Scientific TitleThe effect of Continuous Positive Airway Pressure (CPAP) on the collapsed lung during single-lung-ventilation in patients undergoing robot-assisted thoracoscopic esophageal reseection: pulmonary complications, local and systemic cytokine production.
- ACRONYMCOCTAIL
- hypothesisContinuous positive airway pressure on the deflated lung prevents total alveolar collapse, resulting in less local and systemic cytokine response, causing less pulmonary complications.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteria1. Patients with resectable carcinoma of the esophagus or junction that will undergo robot-assisted thoracoscopic esophago-lymphadenectomy with gastric conduit formation; 2. ASA classification < 4; 3. Written informed consent.
- Exclusion criteria1. Moderate/severe lung function impairment ascertained by pulmonary function tests, requiring high dose steroid therapy; 2. No epidural catheter.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 5-apr-2006
- planned closingdate5-apr-2008
- Target number of participants30
- InterventionsContinuous Positive Airway Pressure (CPAP) to the collapsed lung during single-lung-ventilation vs no CPAP.
- Primary outcomeLocal and systemic cytokine production.
- Secondary outcome1. Pulmonary complications; 2. Ventilation time; 3. ICU stay; 4. Hospital stay.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. R. Hillegersberg, van
- CONTACT for SCIENTIFIC QUERIESMD. PhD. R. Hillegersberg, van
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Comprehensive Cancer Centre (Integraal Kankercentrum)
- PublicationsN/A
- Brief summaryEsophageal cancer is associated with high morbidity, mainly due to pulmonary complications. During the thoracic phase of (robot-assisted) transthoracic esophago-lymphadenectomy, the right lung is deflated to achieve optimal vision. In an animal model, deflation and reinflation of the lung have lead to increased local and systemic cytokine production. This might be the cause of pulmonary complications. Positive airway pressure on the collapsed lung might lead to decreased cytokine production, resulting in less pulmonary complications.
- Main changes (audit trail)
- RECORD28-mrt-2006 - 2-mei-2006


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