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

Not Applicable

• Conditions: Lung Cancer
• Interventions: Procedure: CPAP (Continuous airway pressure)

• Registration Number: NCT01368601
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28
• Primary Completion: 2020-06
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP (positive airway pressure)	CPAP (Continuous airway pressure)	To evaluate if continuous positive airway pressure(CPAP) on the lung undergoing lobectomy can decrease the inflammatory response PPC (postoperative pulmonary complications).

Primary Outcome Measures

Name	Time	Method
Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.	From preoperative to postoperative (24h) period.	Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain