Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response to One-lung Ventilation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response of the Lung With Cancer Undergoing Lobectomy. A Randomised Placebo-controlled Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: CPAP (Continuous airway pressure)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18-80 aged) with American Society of Anesthesiologists physical status I-III, scheduled to undergo elective thoracic surgery with lung resection performed through thoracotomy, and requiring OLV (one lung ventilation)during surgery. Exclusion Criteria: Ongoing treatment with any dose of systemic or topical steroids, acute pulmonary or extrapulmonary infections (elevated C-reactive protein [CRP]), history of recurrent pneumothoraces, previous thoracic surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP (positive airway pressure)<br>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)<br>* To evaluate if continuous positive airway pressure (CPAP) on the lung undergoing lobectomy can decrease the inflammatory response and PPC.<br>|
| No Intervention: Control without CPAP<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion. | Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion. | From preoperative to postoperative (24h) period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar MICA | Alveolar MICA I (major histocompatibility complex (MHC) class I chain related genes) expression measured at the same control times. | From preoperative to postoperative period (24h) | 
| CT-Scan | Postoperative distribution of well-aerated, non aerated or poorly aerated lung volumes. | 22-24h after surgery | 
| Postoperative pulmonary complications (PPC). | PPC. | Participants will be followed for the duration of hospital stay, an expected average of 10 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, CPAP, PPC, lobectomy, One-lung ventilation