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

March 26, 2019 updated by: Lluís Gallart, Parc de Salut Mar

Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response of the Lung With Cancer Undergoing Lobectomy. A Randomised Placebo-controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From preoperative to postoperative (24h) period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From preoperative to postoperative period (24h)
CT-Scan
Time Frame: 22-24h after surgery
Postoperative distribution of well-aerated, non aerated or poorly aerated lung volumes.
22-24h after surgery
Postoperative pulmonary complications (PPC).
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
PPC.
Participants will be followed for the duration of hospital stay, an expected average of 10 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (ESTIMATE)

June 8, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INFLATOR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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