Shunt Evaluation With ALPE System in Thoracic Surgery

NCT ID: NCT02968550

Last Updated: 2017-03-30

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

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

Brief Summary

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. The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress during one lung ventilation (OLV) at different levels of positive end expiratory pressure (PEEP). Moreover, investigators will focus on predicting factors of high shunt levels during OLV.

Detailed Description

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Conditions

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Mechanical Ventilation Thoracic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low shunt group

patients with shunt less than 30% in one-lung ventilation at ZEEP

No interventions assigned to this group

High shunt group

Patients with shunt equal or more than 30% in one-lung ventilation at ZEEP

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for thoracoscopic lobectomy or thoracoscopic wedge resection in lateral decubitus.
* patients American Society of Anesthesiologists Physical Status Classification score of 1-3

Exclusion Criteria

* Patients with hemodynamic instability,
* Patients with severe chronic respiratory failure
* Patients with preoperative anemia (hemoglobin \<10 g 100 ml-1)
* Patients requiring unplanned conversion to thoracotomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Savino Spadaro

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, , Italy

Site Status

Countries

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Italy

References

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Beck DH, Doepfmer UR, Sinemus C, Bloch A, Schenk MR, Kox WJ. Effects of sevoflurane and propofol on pulmonary shunt fraction during one-lung ventilation for thoracic surgery. Br J Anaesth. 2001 Jan;86(1):38-43. doi: 10.1093/bja/86.1.38.

Reference Type BACKGROUND
PMID: 11575407 (View on PubMed)

Other Identifiers

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SEAT

Identifier Type: -

Identifier Source: org_study_id

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