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

NCT ID: NCT01368601

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

CPAP (Continuous airway pressure)

Intervention Type PROCEDURE

To evaluate if continuous positive airway pressure (CPAP) on the lung undergoing lobectomy can decrease the inflammatory response and PPC.

Control without CPAP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CPAP (Continuous airway pressure)

To evaluate if continuous positive airway pressure (CPAP) on the lung undergoing lobectomy can decrease the inflammatory response and PPC.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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LluĂ­s Gallart

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital del Mar

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Lluis Gallart, PhD

Role: primary

0034 93 2483350

Other Identifiers

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INFLATOR

Identifier Type: -

Identifier Source: org_study_id

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