Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response to One-lung Ventilation
This study is currently recruiting participants.
Verified October 2011 by Parc de Salut Mar
Sponsor:
Parc de Salut Mar
Information provided by:
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01368601
First received: May 24, 2011
Last updated: October 20, 2011
Last verified: October 2011
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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: | May 2014 |
| Estimated Primary Completion Date: | January 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
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: | Lluís Gallart, Hospital del Mar- Consorci |
| ClinicalTrials.gov Identifier: | NCT01368601 History of Changes |
| Other Study ID Numbers: | INFLATOR |
| Study First Received: | May 24, 2011 |
| Last Updated: | October 20, 2011 |
| 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 Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013