Lung Ultrasonography and Extravascular Lung Water
Lung Ultrasonography for Detecting Extravascular Lung Water Overload in Intensive Care Patients Early After Surgery: a Preliminary Study
1 other identifier
observational
60
0 countries
N/A
Brief Summary
Aim. To investigate whether lung ultrasound can be used to detect extravascular lung water (EVLW) overload in the intensive care unit early after surgery. Methods. This prospective study involved 60 patients without known cardiac or pulmonary diseases admitted to the intensive care unit at our hospital after elective abdominal or vascular surgery. The inferior vena cava collapsibility index (IVCcl), oxygen partial pressure (PaO2) and inspired oxygen pressure (FiO2) ratio (PaO2/FiO2), and appearance of B-lines ≤7 mm were determined upon admission to the intensive care unit and at 6, 12, and 24 h later. Fluid overload was defined as IVCcl ≤ 40% and the presence of B-lines ≤7 mm. Tissue oxygenation impairment was defined as a PaO2/FiO2 ratio \< 200.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2015
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2015
CompletedFirst Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
March 21, 2017
CompletedMarch 21, 2017
March 1, 2017
8 months
February 23, 2017
March 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Inferior vena cava collapsibility index (IVCcl)
The maximum and minimum IVC diameters (cm) were calculated using ultrasound. IVCcl was measured using formula \[(maximum IVC diameter - minimum IVC diameter)/maximum IVC diameter\] based on changes in the diameter of the inferior vena cava during spontaneous breathing. IVCcl ≤40% was taken to indicate a rise in EVLW, since this cut-off reflects right arterial pressure of 10-15 mmHg.
Baseline- upon admission to the ICU, 6, 12 and 24 hours after admission.
oxygen partial pressure (PaO2) and inspired oxygen pressure (FiO2) ratio
PaO2/FiO2 ratio will be measured from the arterial blood. A decrease in P/F ratio below 200 was taken to indicate a rise of EVLW above 10 ml/kg; this cut-off indicates \>20% shunting.
Baseline- upon admission to the ICU, 6, 12 and 24 hours after admission.
Dense B-lines
The appearance of "dense B-lines" on lung ultrasonography, defined as lines ≤7 mm apart, was also considered a sign of incipient increase in EVLW volume
Baseline- upon admission to the ICU , 6, 12 and 24 hours after admission.
Study Arms (1)
Lung ultrasound and EVLW
This prospective study involved 60 patients without known cardiac or pulmonary diseases admitted to the intensive care unit at our hospital after elective abdominal or vascular surgery. The inferior vena cava collapsibility index (IVCcl), PaO2/FiO2 ratio, and appearance of B-lines ≤7 mm were determined upon admission to the intensive care unit and at 6, 12, and 24 h later. Fluid overload was defined as IVCcl ≤ 40% and the presence of B-lines ≤7 mm. Tissue oxygenation impairment was defined as a PaO2/FiO2 ratio \< 200.
Eligibility Criteria
Patients older than 18 years admitted to the intensive care unit at Clinical Hospital Sveti Duh (Zagreb, Croatia) following elective abdominal or vascular surgery.
You may qualify if:
- patients older than 18 years admitted to the intensive care unit following elective abdominal or vascular surgery
You may not qualify if:
- known cardiac or pulmonary diseases
- lung ultrasonography showed unilateral distribution.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
Berkowitz DM, Danai PA, Eaton S, Moss M, Martin GS. Accurate characterization of extravascular lung water in acute respiratory distress syndrome. Crit Care Med. 2008 Jun;36(6):1803-9. doi: 10.1097/CCM.0b013e3181743eeb.
PMID: 18496374BACKGROUNDPhillips CR, Chesnutt MS, Smith SM. Extravascular lung water in sepsis-associated acute respiratory distress syndrome: indexing with predicted body weight improves correlation with severity of illness and survival. Crit Care Med. 2008 Jan;36(1):69-73. doi: 10.1097/01.CCM.0000295314.01232.BE.
PMID: 18090369BACKGROUNDCraig TR, Duffy MJ, Shyamsundar M, McDowell C, McLaughlin B, Elborn JS, McAuley DF. Extravascular lung water indexed to predicted body weight is a novel predictor of intensive care unit mortality in patients with acute lung injury. Crit Care Med. 2010 Jan;38(1):114-20. doi: 10.1097/CCM.0b013e3181b43050.
PMID: 19789451BACKGROUNDTagami T, Sawabe M, Kushimoto S, Marik PE, Mieno MN, Kawaguchi T, Kusakabe T, Tosa R, Yokota H, Fukuda Y. Quantitative diagnosis of diffuse alveolar damage using extravascular lung water. Crit Care Med. 2013 Sep;41(9):2144-50. doi: 10.1097/CCM.0b013e31828a4643.
PMID: 23760152BACKGROUNDCovelli HD, Nessan VJ, Tuttle WK 3rd. Oxygen derived variables in acute respiratory failure. Crit Care Med. 1983 Aug;11(8):646-9. doi: 10.1097/00003246-198308000-00012.
PMID: 6409506BACKGROUNDZhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.
PMID: 26298866BACKGROUNDItobi E, Stroud M, Elia M. Impact of oedema on recovery after major abdominal surgery and potential value of multifrequency bioimpedance measurements. Br J Surg. 2006 Mar;93(3):354-61. doi: 10.1002/bjs.5259.
PMID: 16463271BACKGROUND
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 23, 2017
First Posted
March 21, 2017
Study Start
April 1, 2015
Primary Completion
November 20, 2015
Study Completion
November 30, 2015
Last Updated
March 21, 2017
Record last verified: 2017-03