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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01368601
• Other study ID #: INFLATOR
• Status: Recruiting
• Phase: N/A
• Start date: May 2011
• Est. completion date: October 2020

Study information

• Verified date: March 2019
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	CT-Scan	Postoperative distribution of well-aerated, non aerated or poorly aerated lung volumes.	22-24h after surgery
Secondary	Postoperative pulmonary complications (PPC).	PPC.	Participants will be followed for the duration of hospital stay, an expected average of 10 days.