Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586060
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-31
Brief Title:
Lung Ultrasound Guided Fluid Balance Strategy in Patients with Lung Contusion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Lung Ultrasound Guided Fluid Balance Strategy in Patients with Lung Contusion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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 mgday
In case of shocked patients with BLS lt 15 they will receive fluid boluses and packed RBCs to achieve a Hb of 10 and a MAP of gt65 mmHg
In case of shocked patients with BLS 15 they will start norepinephrine infusion to reach a MAP of gt65 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
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 11 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 mgday
In case of shocked patients with BLS lt 15 they will receive fluid boluses and packed RBCs to achieve a Hb of 10 and a MAP of gt65 mmHg
In case of shocked patients with BLS 15 they will start norepinephrine infusion to reach a MAP of gt65 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
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 11 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 hyperechoiccomet-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 mgday
In case of shocked patients with BLS lt 15 they will receive fluid boluses and packed RBCs to achieve a Hb of 10 and a MAP of gt65 mmHg
In case of shocked patients with BLS 15 they will start norepinephrine infusion to reach a MAP of gt65 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
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 11 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 hyperechoiccomet-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 mgday
In case of shocked patients with BLS lt 15 they will receive fluid boluses and packed RBCs to achieve a Hb of 10 and a MAP of gt65 mmHg
In case of shocked patients with BLS 15 they will start norepinephrine infusion to reach a MAP of gt65 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None