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Volumetric Monitoring in Major Lung Surgery (EVLW-PNEUMO)

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ClinicalTrials.gov Identifier: NCT01455766
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : September 5, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The hypothesis of this observational single-center clinical study was to explore the volumetric hemodynamic monitoring in the perioperative period in major and risky thoracic intervention. The investigators monitored the changes in the volumes of blood in the central vessels and heart chambers as well as a volume of fluid in pulmonary tissue (i. e. extravascular lung water).

Condition or disease
Pneumonectomy Acute Pulmonary Edema

Detailed Description:
The goal of this observational study is to investigate into changes in volumetric hemodynamic parameters obtained with a technique of transpulmonary indicator dilution after major thoracic intervention, including pneumonectomy and lobar resections. The important parameters of hemodynamics were monitored throughout the intervention and 48 hrs postoperatively, including extravascular lung water index, global end-diastolic volume index, etc.

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Edema Following Major Thoracic Resections: a Value of Perioperative Volumetric Monitoring
Study Start Date : June 2005
Primary Completion Date : February 2008
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples Without DNA
Blood plasma for non-specified additional retrospective tests.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population includes the patients scheduled for extended thoracic resections (lobar resection and pneumonectomy) due to bronchial cancer or severe destructive pulmonary infection (abscess and/or pneumonia).
Criteria

Inclusion Criteria:

  • Informed consent
  • Age above 18 and below 80
  • Confirmed malignant bronchial neoplasm or
  • Destructive pulmonary infection

Exclusion Criteria:

  • Pregnant
  • Severe pulmonary hypertension
  • Pulmonary tuberculosis
  • Severe occlusive atherosclerosis of lower extremities
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455766


Locations
Russian Federation
Regional Hospital of Arkhangelsk
Arkhangelsk, Arkhangelsk Region, Russian Federation, 163000
Sponsors and Collaborators
Northern State Medical University
Regional hospital of Arkhangelsk
University of Tromso
Investigators
Principal Investigator: Vsevolod V. Kuzkov, MD, PhD Northern State Medical University
Principal Investigator: Mikhail M. Orlov, MD Regional hospital of Arkhangelsk
Study Chair: Mikhail Y. Kirov, MD, PhD Northern State Medical University
Study Director: Lars J. Bjertnaes, MD, PhD University of Trmsoe, Tromsoe, Norway
More Information

Responsible Party: Vsevolod V. Kuzkov, Associate Professor, MD, PhD, Northern State Medical University
ClinicalTrials.gov Identifier: NCT01455766     History of Changes
Other Study ID Numbers: 2005-2011
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012

Keywords provided by Vsevolod V. Kuzkov, Northern State Medical University:
postpneumonectomy pulmonary edema
extravascular lung water

Additional relevant MeSH terms:
Edema
Pulmonary Edema
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases