PneumonectomyEVLW-PNEUMONCT01455766
Volumetric Monitoring in Major Lung Surgery
An observational study of Pneumonectomy and Acute Pulmonary Edema, run by Northern State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumonectomy, Acute Pulmonary Edema
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2005to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Informed consent
- Age above 18 and below 80
- Confirmed malignant bronchial neoplasm or
- Destructive pulmonary infection
Who cannot join
- Pregnant
- Severe pulmonary hypertension
- Pulmonary tuberculosis
- Severe occlusive atherosclerosis of lower extremities
Trial locations and contacts
1 site in 1 country.
Russia1 site
Regional Hospital of Arkhangelsk
Arkhangelsk, Arkhangelskaya oblast, 163000
About this study
Official title: Pulmonary Edema Following Major Thoracic Resections: a Value of Perioperative Volumetric Monitoring
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).
Read the 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.
- Conditions
- Pneumonectomy, Acute Pulmonary Edema
- Keywords
- postpneumonectomy pulmonary edema, extravascular lung water
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJun 2005
- Primary completionFeb 2008
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumonectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Regional hospital of Arkhangelsk, University of Tromso
- Responsible party
- Principal investigator, Vsevolod V. Kuzkov, Northern State Medical University
- Investigators
- Vsevolod V. Kuzkov, MD, PhD, Principal investigator, Northern State Medical UniversityMikhail M. Orlov, MD, Principal investigator, Regional hospital of ArkhangelskMikhail Y. Kirov, MD, PhD, Study chair, Northern State Medical UniversityLars J. Bjertnaes, MD, PhD, Study director, University of Trmsoe, Tromsoe, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455766
- Sponsor's protocol ID
- 2005-2011
- Acronym
- EVLW-PNEUMO
- Status last verified
- Sep 2012
- First submitted
- 17 Oct 2011
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Edema Following Major Thoracic Resections: a Value of Perioperative Volumetric Monitoring
- ClinicalTrials.gov ID
- NCT01455766
- Acronym / sponsor ID
- EVLW-PNEUMO / 2005-2011
- Conditions
- Pneumonectomy, Acute Pulmonary Edema
- Keywords
- postpneumonectomy pulmonary edema, extravascular lung water
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Collaborators
- Regional hospital of Arkhangelsk, University of Tromso
- Study start
- Jun 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- Informed consent
- Age above 18 and below 80
- Confirmed malignant bronchial neoplasm or
- Destructive pulmonary infection
Key exclusion criteria (4 listed)
- Pregnant
- Severe pulmonary hypertension
- Pulmonary tuberculosis
- Severe occlusive atherosclerosis of lower extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vsevolod V. Kuzkov, MD, PhD principal investigator
Northern State Medical University
Mikhail M. Orlov, MD principal investigator
Regional hospital of Arkhangelsk
Mikhail Y. Kirov, MD, PhD study chair
Northern State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonectomy and Acute Pulmonary Edema, run by Northern State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2012.