Volumetric Monitoring in Major Lung Surgery

Pneumonectomy Clinical Trial

— EVLW-PNEUMO  

Official title:

Pulmonary Edema Following Major Thoracic Resections: a Value of Perioperative Volumetric Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455766
• Other study ID #: 2005-2011
• Status: Completed
• Phase: N/A
• First received: October 17, 2011
• Last updated: September 4, 2012
• Start date: June 2005
• Est. completion date: November 2011

Study information

• Verified date: September 2012
• Source: Northern State Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2011
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pulmonary Edema
• Pneumonectomy
• Pulmonary Edema

Locations

Country	Name	City	State
Russian Federation	Regional Hospital of Arkhangelsk	Arkhangelsk	Arkhangelsk Region

Sponsors (3)

Lead Sponsor	Collaborator
Northern State Medical University	Regional hospital of Arkhangelsk, University of Tromso

Country where clinical trial is conducted

Russian Federation,