ClinicalTrials.gg
Not yet recruitingNCT06586060Updated Sep 19, 2024

Lung Ultrasound Guided Fluid Balance Strategy in Patients with Lung Contusion

An interventional study of lung ultrasound guided fluid balance strategy and usual care guided fluid balance strategy in Lung Contusion, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Assiut University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Lung contusion is caused by blunt chest trauma, explosion injuries or a shock wave associated with penetrating trauma. These injuries damage alveolar capillaries, so blood and other fluids accumulate in the lung tissue. The excess fluid interferes with gas exchange leading to hypoxia To find out whether lung ultrasound as a non-invasive tool can be used to tailor the better fluid balance strategy to achieve higher oxygenation compared to other conventional methods in patients with lung contusion.

The study will evaluate a fluid management protocol for adult patients, based on the daily assessment of B-line score (BLS) using lung ultrasound, compared to usual care. A pre-specified BLS cut-off value of 15 will be used in this study to correct fluid overload After enrolment, patients were randomly assigned to BLS-guided fluid management (active group) or standard care (control group) in a 1:1 ratio, using a computerised random-number generator.

lung ultrasound guided fluid management based on BLS assessment will be conducted within 24 hours of icu admission and daily thereafter until icu discharge or for up to 14 days after randomization which ever comes first In the active group, with every LU examination, patients will be stratified into four classes: no EVLW increase (BLS = 0-4), mild increase (BLS = 5-14), moderate increase (BLS = 15-29), or severe EVLW increase (BLS ≥ 30).

In patients with no or mild EVLW increase (BLS = 0-14), a zero fluid balance (FB) will be targeted if no signs of shock are present. In patients with a moderate or severe increase in EVLW (BLS ≥ 15), a daily negative FB of -250 to -1000 mL will be targeted until BLS drops under 15. To reach daily targeted FB, furosemide-induced diuresis and RRT will be used. Furosemide will be administrated in a stepwise manner considering the previous furosemide dose and the FB achieved. If the targeted FB is achieved from the first day of diuretic administration, the furosemide dose will be maintained. If FB is outside the targeted range, the furosemide dose will be progressively reduced or increased until the goal is achieved. RRT will be used in patients with moderate and severe EVLW increase (BLS ≥ 15) if the targeted FB cannot be reached despite using the maximum furosemide dose of 800 mg/day.

In case of shocked patients with BLS \< 15: they will receive fluid boluses and packed RBCs to achieve a Hb of 10 and a MAP of >65 mmHg.

In case of shocked patients with BLS ≥ 15: they will start norepinephrine infusion to reach a MAP of >65 mmHg.

In the control group, fluid management will be guided to maintain an adequate intravascular volume while minimising weight gain. Various parameters will be used to attain this goal based on case-by-case clinical judgment: lung sounds, heart rate, blood pressure, temperature, urine output, FB, lactate, haemoglobin, haematocrit, serum urea, creatinine, sodium, potassium, chloride, and bicarbonate values

Research outcome measures:

  1. Primary (main):

    Difference in p-f ratio between the two groups to find out the best strategy for fluid balance for best p-f ratio.

  2. Secondary (subsidiary):

Duration of ventilation Duration of ICU stay Duration of hospital stay

Read the detailed description

Lung contusion is caused by blunt chest trauma, explosion injuries or a shock wave associated with penetrating trauma. These injuries damage alveolar capillaries, so blood and other fluids accumulate in the lung tissue. The excess fluid interferes with gas exchange leading to hypoxia. The pathophysiology of lung contusion includes ventilation / perfusion mismatching, increased intrapulmonary shunting, increased lung water, segmental lung damage, and a loss of compliance.

Fluid replacement is required to ensure adequate blood volume, but this should be done carefully as fluid overload can worsen pulmonary edema, which may be damaging. There may be wheezing, coughing, bronchorrhea and blood-streaked sputum in up to half of cases. There may be hypotension and reduced cardiac output.

Pulmonary contusion results in bleeding and fluid leakage into lung tissue, which becomes rigid and loses its normal elasticity. The water content of the lung increases over the first 72 hours after injury, and may lead to frank pulmonary edema in more serious cases.

Recently lung ultrasound has emerged as golden tool asses over hydration through the B -LINES score Lung ultrasound has the advantages of being safe, non-invasive and already part of different diagnostic algorithm of life threatening conditions with real time detection of increased extravascular lung water and providing a valuable safety threshold to conduct fluid therapy and optimize volume status.

Aim of the study:

To find out whether lung ultrasound as a non-invasive tool can be used to tailor the better fluid balance strategy to achieve higher oxygenation compared to other conventional methods in patients with lung contusion.

The study will evaluate a fluid management protocol for adult patients, based on the daily assessment of B-line score (BLS) using lung ultrasound, compared to usual care. A pre-specified BLS cut-off value of 15 will be used in this study to correct fluid overload.

Type of the study: prospective randomized controlled trial Study Setting: Emergency department at Assiut University Hospital

Study subjects:

  1. Inclusion criteria:

    1. poly trauma patients with lung contusion
    2. isolated lung contusion
    3. blunt chest trauma associated with lung contusion
  2. Exclusion criteria:

    1. patient refusal
    2. pregnancy
    3. age less than 18.
    4. Patients with known pulmonary conditions that interfere with interpretation of LUS eg: pulmonary fibrosis ,persistent pleural effusion and pnemonectomy .

After enrolment, patients were randomly assigned to BLS-guided fluid management (active group) or standard care (control group) in a 1:1 ratio, using a computerised random-number generator.

3-lung ultrasound guided fluid management based on BLS assessment within 24 hours of icu admission and daily thereafter until icu discharge or for up to 14 days after randomization which ever comes first All patients will be clinically examined daily in the morning and LUS will be performed at bedside with the patient in supine position . the lung will be scanned from the second to fourth intercostal space on the left and from the second to fifth intercostal space on the right at para sternal , mid clavicular , anterior axillary and mid axillary lines .

The focus of the image will be set at the pleural line level and the depth of penetration will be set to 10 cm. The ultrasound equipment will be the GE LOGIQ ® ultrasound system with the curved probe.

B-lines are hyperechoic,comet-tail artefacts, which emerge from the level of the pleural line and move synchronously with lung sliding.

B-lines will be recorded in each intercostal space (28 site of examination ) .the sum of all B lines will produce a score BLS reflecting the extent of extra vascular lung water accumulation Fluid Management In the active group, with every LU examination, patients will be stratified into four classes: no EVLW increase (BLS = 0-4), mild increase (BLS = 5-14), moderate increase (BLS = 15-29), or severe EVLW increase (BLS ≥ 30).

In patients with no or mild EVLW increase (BLS = 0-14), a zero fluid balance (FB) will be targeted if no signs of shock are present. In patients with a moderate or severe increase in EVLW (BLS ≥ 15), a daily negative FB of -250 to -1000 mL will be targeted until BLS drops under 15. To reach daily targeted FB, furosemide-induced diuresis and RRT will be used. Furosemide will be administrated in a stepwise manner considering the previous furosemide dose and the FB achieved. If the targeted FB is achieved from the first day of diuretic administration, the furosemide dose will be maintained. If FB is outside the targeted range, the furosemide dose will be progressively reduced or increased until the goal is achieved. RRT will be used in patients with moderate and severe EVLW increase (BLS ≥ 15) if the targeted FB cannot be reached despite using the maximum furosemide dose of 800 mg/day.

In case of shocked patients with BLS \< 15: they will receive fluid boluses and packed RBCs to achieve a Hb of 10 and a MAP of >65 mmHg.

In case of shocked patients with BLS ≥ 15: they will start norepinephrine infusion to reach a MAP of >65 mmHg.

In the control group, fluid management will be guided to maintain an adequate intravascular volume while minimising weight gain. Various parameters will be used to attain this goal based on case-by-case clinical judgment: lung sounds, heart rate, blood pressure, temperature, urine output, FB, lactate, haemoglobin, haematocrit, serum urea, creatinine, sodium, potassium, chloride, and bicarbonate values. Additionally, central venous oxygen saturation, pulse pressure variation and stroke volume variation will be used to assess fluid responsiveness in patients with shock.

Arterial blood gases for p-f ratio will be calculated daily for both groups.

02

Conditions studied

  • Lung Contusion

Browse trials for

03

In context

Contusions

43 studies on the registry are indexed under Contusions; 8 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 31 interventional studies indexed under Contusions.

Browse Contusions studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. poly trauma patients with lung contusion
  2. isolated lung contusion
  3. blunt chest trauma associated with lung contusion

Exclusion criteria

Exclusion Criteria:

  1. patient refusal
  2. pregnancy
  3. age less than 18.
  4. Patients with known pulmonary conditions that interfere with interpretation of LUS eg: pulmonary fibrosis ,persistent pleural effusion and pnemonectomy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    LUS group

    lung ultrasound guided fluid management guided by B-line score (BLS). In patients with no or mild extravascular lung water (EVLW) increase (BLS = 0-14), a zero fluid balance (FB) will be targeted if no signs of shock are present. In patients with a moderate or severe increase in EVLW (BLS ≥ 15), a daily negative FB of -250 to -1000 mL will be targeted until BLS drops under 15. To reach daily targeted FB, furosemide-induced diuresis and RRT will be used. Furosemide will be administrated in a stepwise manner considering the previous furosemide dose and the FB achieved. If the targeted FB is achieved from the first day of diuretic administration, the furosemide dose will be maintained. If FB is outside the targeted range, the furosemide dose will be progressively reduced or increased until the goal is achieved. RRT will be used in patients with moderate and severe EVLW increase (BLS ≥ 15) if the targeted FB cannot be reached despite using the maximum furosemide dose of 800 mg/day.

    Other: lung ultrasound guided fluid balance strategy

  • Active comparator
    control group

    fluid management will be guided to maintain an adequate intravascular volume while minimising weight gain.fluid and diuretics administration will be given according to the clinical judgement of the treating ICU physician. Various parameters will be used to attain this goal based on case-by-case clinical judgment: lung sounds, heart rate, blood pressure, temperature, urine output, FB, lactate, haemoglobin, haematocrit, serum urea, creatinine, sodium, potassium, chloride, and bicarbonate values

    Other: usual care guided fluid balance strategy

Interventions

  • Otherlung ultrasound guided fluid balance strategy

    Lung ultrasound (LUS) guided fluid management based on B-Line score assessment using LUS within 24 hours of icu admission and daily thereafter until icu discharge or for up to 14 days after randomization which ever comes first In patients with BLS = 0-14, a zero fluid balance (FB) will be targeted if no signs of shock are present. In patients with BLS ≥ 15, a daily negative FB of -250 to -1000 mL will be targeted until BLS drops under 15. To reach daily targeted FB, furosemide-induced diuresis and RRT will be used In case of shocked patients with BLS \&amp;amp;lt; 15: they will receive fluid boluses and packed RBCs to achieve a Hb of 10 and a MAP of \&amp;amp;gt;65 mmHg. In case of shocked patients with BLS ≥ 15: they will start norepinephrine infusion to reach a MAP of \&amp;amp;gt;65 mmHg.

  • Otherusual care guided fluid balance strategy

    fluid balance management will be guided to maintain an adequate intravascular volume while minimising weight gain within 24 hours of icu admission and daily thereafter until icu discharge or for up to 14 days after randomization which ever comes first. Various parameters will be used to attain this goal based on case-by-case clinical judgment: lung sounds, heart rate, blood pressure, temperature, urine output, lactate, haemoglobin, haematocrit, serum urea, creatinine, sodium, potassium, chloride, and bicarbonate values To reach daily targeted fluid balance, furosemide-induced diuresis and RRT will be used

06

What researchers measure

Primary outcomes

  1. PaO2/FiO2 ratio

    obtained from arterial blood gases

    Time frame: once daily at 10 a.m. for 14 days after randomization

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06586060
Lead sponsor
Assiut University
Responsible party
Ibraheem Abdelmageed (lecturer, Assiut University) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 2024 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion