Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response to One-lung Ventilation
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable lung-cancer
Started May 2011
Longer than P75 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 24, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedMarch 28, 2019
March 1, 2019
9.1 years
May 24, 2011
March 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Alveolar MICA
From preoperative to postoperative period (24h)
CT-Scan
22-24h after surgery
Postoperative pulmonary complications (PPC).
Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Study Arms (2)
CPAP (positive airway pressure)
ACTIVE COMPARATORTo evaluate if continuous positive airway pressure(CPAP) on the lung undergoing lobectomy can decrease the inflammatory response PPC (postoperative pulmonary complications).
Control without CPAP
NO INTERVENTIONInterventions
To evaluate if continuous positive airway pressure (CPAP) on the lung undergoing lobectomy can decrease the inflammatory response and PPC.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital del Mar
Barcelona, 08003, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 24, 2011
First Posted
June 8, 2011
Study Start
May 1, 2011
Primary Completion
June 1, 2020
Study Completion
October 1, 2020
Last Updated
March 28, 2019
Record last verified: 2019-03