Volumetric Monitoring in Major Lung Surgery (EVLW-PNEUMO)

This study has been completed.
Sponsor:
Collaborators:
Regional hospital of Arkhangelsk
University of Tromso
Information provided by (Responsible Party):
Vsevolod V. Kuzkov, Northern State Medical University
ClinicalTrials.gov Identifier:
NCT01455766
First received: October 17, 2011
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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
Pneumonectomy
Acute Pulmonary Edema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Edema Following Major Thoracic Resections: a Value of Perioperative Volumetric Monitoring

Resource links provided by NLM:


Further study details as provided by Northern State Medical University:

Biospecimen Retention:   Samples Without DNA

Blood plasma for non-specified additional retrospective tests.


Estimated Enrollment: 50
Study Start Date: June 2005
Study Completion Date: November 2011
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 17, 2011
Last Updated: September 4, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by 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

ClinicalTrials.gov processed this record on August 20, 2014