Back to resultsEffects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response to One-lung Ventilation
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CPAP (Continuous airway pressure)
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, CPAP, PPC, lobectomy, One-lung ventilation
Eligibility 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.
Sites / Locations
- Hospital del MarRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CPAP (positive airway pressure)
Control without CPAP
Arm Description
To evaluate if continuous positive airway pressure(CPAP) on the lung undergoing lobectomy can decrease the inflammatory response PPC (postoperative pulmonary complications).
Outcomes
Primary Outcome Measures
Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.
Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.
Secondary Outcome Measures
Alveolar MICA
Alveolar MICA I (major histocompatibility complex (MHC) class I chain related genes) expression measured at the same control times.
CT-Scan
Postoperative distribution of well-aerated, non aerated or poorly aerated lung volumes.
Postoperative pulmonary complications (PPC).
PPC.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01368601
Brief Title
Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response to One-lung Ventilation
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 Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer, CPAP, PPC, lobectomy, One-lung ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPAP (positive airway pressure)
Arm Type
Active Comparator
Arm Description
To evaluate if continuous positive airway pressure(CPAP) on the lung undergoing lobectomy can decrease the inflammatory response PPC (postoperative pulmonary complications).
Arm Title
Control without CPAP
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
CPAP (Continuous airway pressure)
Intervention Description
To evaluate if continuous positive airway pressure (CPAP) on the lung undergoing lobectomy can decrease the inflammatory response and PPC.
Primary Outcome Measure Information:
Title
Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.
Description
Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.
Time Frame
From preoperative to postoperative (24h) period.
Secondary Outcome Measure Information:
Title
Alveolar MICA
Description
Alveolar MICA I (major histocompatibility complex (MHC) class I chain related genes) expression measured at the same control times.
Time Frame
From preoperative to postoperative period (24h)
Title
CT-Scan
Description
Postoperative distribution of well-aerated, non aerated or poorly aerated lung volumes.
Time Frame
22-24h after surgery
Title
Postoperative pulmonary complications (PPC).
Description
PPC.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 10 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lluis Gallart, PhD
Phone
0034 93 2483350
Email
Lgallart@parcdesalutmar.cat
12. IPD Sharing Statement
Learn more about this trial
Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response to One-lung Ventilation
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