NCT03085862

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2015

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

February 23, 2017

Last Update Submit

March 15, 2017

Conditions

Keywords

UltrasonographyExtravascular lung waterPaO2/FiO2 ratio

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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: 18496374BACKGROUND
  • Phillips 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: 18090369BACKGROUND
  • Craig 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: 19789451BACKGROUND
  • Tagami 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: 23760152BACKGROUND
  • Covelli 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: 6409506BACKGROUND
  • Zhao 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: 26298866BACKGROUND
  • Itobi 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