Extravascular Lung WaterNCT03085862
Lung Ultrasonography and Extravascular Lung Water
An observational study of Extravascular Lung Water, run by General Hospital Sveti Duh.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extravascular Lung Water
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 30 Nov 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients older than 18 years admitted to the intensive care unit following elective abdominal or vascular surgery
Who cannot join
- known cardiac or pulmonary diseases
- lung ultrasonography showed unilateral distribution.
About this study
Official title: 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.
Read the 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.
.
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.
- Conditions
- Extravascular Lung Water
- Keywords
- Ultrasonography, Extravascular lung water, PaO2/FiO2 ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Baseline- upon admission to the ICU , 6, 12 and 24 hours after admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Apr 2015
- Primary completion20 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Extravascular Lung WaterStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Sveti Duh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Karaman Ilic, General Hospital Sveti Duh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085862
- Sponsor's protocol ID
- GHSvetiDuh
- Status last verified
- Mar 2017
- First submitted
- 23 Feb 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18496374Phillips 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.
PubMed 18090369Craig 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.
PubMed 19789451Tagami 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.
PubMed 23760152Covelli 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.
PubMed 6409506Zhao 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.
PubMed 26298866Itobi 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.
PubMed 16463271
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasonography for Detecting Extravascular Lung Water Overload in Intensive Care Patients Early After Surgery: a Preliminary Study
- ClinicalTrials.gov ID
- NCT03085862
- Acronym / sponsor ID
- GHSvetiDuh
- Conditions
- Extravascular Lung Water
- Keywords
- Ultrasonography, Extravascular lung water, PaO2/FiO2 ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- General Hospital Sveti DuhUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 20 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 21 Mar 2017 (actual)
- 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.
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.
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.
.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients older than 18 years admitted to the intensive care unit following elective abdominal or vascular surgery
Key exclusion criteria (2 listed)
- known cardiac or pulmonary diseases
- lung ultrasonography showed unilateral distribution.
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
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.
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.
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
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 21 Mar 2017.
- Background: PubMed 18496374Berkowitz 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.
- Background: PubMed 18090369Phillips 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.
- Background: PubMed 19789451Craig 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.
- Background: PubMed 23760152Tagami 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.
- Background: PubMed 6409506Covelli 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.
- Background: PubMed 26298866Zhao 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.
- Background: PubMed 16463271Itobi 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Extravascular Lung Water, run by General Hospital Sveti Duh.
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 1 inclusion and 2 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Inferior vena cava collapsibility index (IVCcl) (time frame: Baseline- upon admission to the ICU, 6, 12 and 24 hours after admission.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085862, which also lists 7 linked publications.
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 21 Mar 2017.