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

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ClinicalTrials.gov Identifier: NCT01368601
Recruitment Status : Recruiting
First Posted : June 8, 2011
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Lluís Gallart, 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: CPAP (Continuous airway pressure) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : May 2011
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion. [ Time Frame: From preoperative to postoperative (24h) period. ]
    Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.


Secondary Outcome Measures :
  1. Alveolar MICA [ Time Frame: 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.

  2. CT-Scan [ Time Frame: 22-24h after surgery ]
    Postoperative distribution of well-aerated, non aerated or poorly aerated lung volumes.

  3. Postoperative pulmonary complications (PPC). [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days. ]
    PPC.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368601


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

Responsible Party: Lluís Gallart, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01368601     History of Changes
Other Study ID Numbers: INFLATOR
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

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