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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Parc de Salut Mar
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01368601
First received: May 24, 2011
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Lung Cancer
Procedure: CPAP (Continuous airway pressure)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368601

Locations
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Lluis Gallart, PhD    0034 93 2483350 ext -    Lgallart@parcdesalutmar.cat   
Sponsors and Collaborators
Parc de Salut Mar
  More Information

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01368601     History of Changes
Other Study ID Numbers: INFLATOR
Study First Received: May 24, 2011
Last Updated: May 12, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Parc de Salut Mar:
Lung Cancer
CPAP
PPC
lobectomy
One-lung ventilation

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014