Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response to One-lung Ventilation
This is a randomized placebo-controlled trial studying the effects of intraoperative continuous airway pressure (CPAP) on the inflammatory response of the lung with cancer undergoing lobectomy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response of the Lung With Cancer Undergoing Lobectomy. A Randomised Placebo-controlled Trial|
- Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion. [ Time Frame: From preoperative to postoperative (24h) period. ] [ Designated as safety issue: Yes ]Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.
- Alveolar MICA [ Time Frame: From preoperative to postoperative period (24h) ] [ Designated as safety issue: Yes ]Alveolar MICA I (major histocompatibility complex (MHC) class I chain related genes) expression measured at the same control times.
- CT-Scan [ Time Frame: 22-24h after surgery ] [ Designated as safety issue: Yes ]Postoperative distribution of well-aerated, non aerated or poorly aerated lung volumes.
- Postoperative pulmonary complications (PPC). [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days. ] [ Designated as safety issue: Yes ]PPC.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: CPAP (positive airway pressure)
To evaluate if continuous positive airway pressure(CPAP) on the lung undergoing lobectomy can decrease the inflammatory response PPC (postoperative pulmonary complications).
Procedure: CPAP (Continuous airway pressure)
To evaluate if continuous positive airway pressure (CPAP) on the lung undergoing lobectomy can decrease the inflammatory response and PPC.
|No Intervention: Control without CPAP|
Pulmonary lobectomy induces an inflammatory response of this lung caused by intraoperative atelectasis and re-expansion. This inflammatory response can be attenuated with treatment, also decreasing postoperative pulmonary complications (PPC). Thus, avoiding complete atelectasis with partial insufflation of the lung during surgery could be useful to decrease inflammatory response and PPC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368601
|Hospital del Mar||Recruiting|
|Barcelona, Spain, 08003|
|Contact: Lluis Gallart, PhD 0034 93 2483350 ext - Lgallart@parcdesalutmar.cat|