Lung Ultrasonography and Extravascular Lung Water

Extravascular Lung Water Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085862
• Other study ID #: GHSvetiDuh
• Status: Completed
• Phase: N/A
• First received: February 23, 2017
• Last updated: March 15, 2017
• Start date: April 1, 2015
• Est. completion date: November 30, 2015

Study information

• Verified date: March 2017
• Source: General Hospital Sveti Duh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2015
• Est. primary completion date: November 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Extravascular Lung Water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Sveti Duh

References & 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. — View Citation

Covelli HD, Nessan VJ, Tuttle WK 3rd. Oxygen derived variables in acute respiratory failure. Crit Care Med. 1983 Aug;11(8):646-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.