Lung Ultrasonography and Extravascular Lung Water

March 15, 2017 updated by: Maja Karaman Ilic, General Hospital Sveti Duh

Lung Ultrasonography for Detecting Extravascular Lung Water Overload in Intensive Care Patients Early After Surgery: a Preliminary Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

After receiving general anesthesia, all patients received an endotracheal tube. After Co induction, anesthesia was maintained using a combination of inhalation anesthetic and intravenous drugs. Protective ventilation was combined with low flow. During surgery, all patients received Plasma Lyte 148 (pH 7.4; Viaflo, Baxter, Deerfield, IL, USA) at 6-8 ml/kg/h. Norepinephrine was administered at doses of 0.05-0.1 mcg/kg/min when needed to maintain mean arterial pressure over 60 mmHg. Packed red blood cells were used when hemoglobin concentration was ≤8.0 g/dl. At the end of anesthesia, participants were subjected to the recruitment maneuver. Patients older than 18 years admitted to intensive care unit after abdominal and vascular surgery with no cardiac or pulmonary diseases were included in the study.

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After surgery, patients were admitted to the intensive care unit and given crystalloid Plasma Lyte at 1.5 ml/kg/h. At 24 h after surgery, all patients received the diuretic furosemide (20 mg).

Data on oxygen partial pressure and inspired oxygen pressure ratio (PaO2/FiO2), inferior vena cava collapsibility index (IVCcl) and occurrence of dense B-lines were monitored upon admission to the intensive care unit (baseline), as well as at 6, 12 and 24 h after admission. All measurements were done with the patients in supine position.

A decrease in PaO2/FiO2 ratio below 200 was taken to indicate a rise of extravascular lung water (EVLW) above 10 ml/kg (1-4); this cut-off indicates >20% shunting (5). IVCcl was measured 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 (6). 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 (7). Taking PaO2/FiO2 ratio as the reference method, we assessed the ability of dense B-lines, alone or in conjunction with IVCcl, to diagnose EVLW.

Statistical analysis was performed using SPSS 13 (Armonk, NY,USA). Independent-sample t tests were used to assess the significance of differences within groups for each set of measurements separately. The threshold of significance was p < 0.05. Possible correlation of PaO2/FiO2 ratio with occurrence of dense B-lines or with IVCcl ≤40% was assessed using the chi-squared test.

Study Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • patients older than 18 years admitted to the intensive care unit following elective abdominal or vascular surgery

Exclusion Criteria:

  • known cardiac or pulmonary diseases
  • lung ultrasonography showed unilateral distribution.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inferior vena cava collapsibility index (IVCcl)
Time Frame: Baseline- upon admission to the ICU, 6, 12 and 24 hours after admission.
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
Time Frame: Baseline- upon admission to the ICU, 6, 12 and 24 hours after admission.
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
Time Frame: Baseline- upon admission to the ICU , 6, 12 and 24 hours after admission.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital Sveti Duh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2015

Primary Completion (ACTUAL)

November 20, 2015

Study Completion (ACTUAL)

November 30, 2015

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (ACTUAL)

March 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GHSvetiDuh

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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