Role of Lung Ultrasound In Assessment Of Recruitment Maneuvers In Ventilated Preterms With Respiratory Distress Syndrome and Its Correlation With Tracheal IL-6 Level

Study Overview
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Brief Summary
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This work is designed to: Evaluate the efficacy of lung ultrasonography in detecting opening and closing lung pressures in ventilated preterm neonates with respiratory distress syndrome. Determine the efficacy of lung ultrasonography in optimizing lung volume and its correlation with pulmonary inflammatory reaction as evidenced by IL-6 level in tracheal aspirate.

Detailed Description
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The studied population included 44 preterm infants. Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups. The studied population included 44 preterm infants. Then they were allocated randomly to one of 2 groups in order by admission: Group A: included 22 patients on whom the recruitment maneuver was applied guided by lung ultrasonography. Group B: included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group. Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups.

Official Title
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Role of Lung Ultrasound In Assessment Of Recruitment Maneuvers In Ventilated Preterms With Respiratory Distress Syndrome and Its Correlation With Tracheal IL-6 Level

Conditions
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Respiratory Distress Syndrome, Newborn

Intervention / Treatment
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* Other: lung recruitment maneuver
* Other: tracheal IL-6 level
* Other: US guided lung recruitment maneuver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age ≤ 36 weeks. In need for invasive mechanical ventilation for RDS according to Downes Score . Exclusion Criteria: excluded: Major upper or lower airway anomalies. Significant congenital anomalies including cardiac, abdominal or respiratory. Surgical cases Inborn errors of metabolism Early onset sepsis. Meconium aspiration syndrome. Hypoxic ischemic encephalopathy.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study was conducted on 44 preterm neonates who were mechanically ventilated for respiratory distress syndrome (RDS). Then they were allocated randomly to one of 2 groups in order by admission: Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography. Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: US guided lung recruitment<br>Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography. | Other: lung recruitment maneuver<br>* Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome<br>Other: tracheal IL-6 level<br>* tracheal IL-6 level was measured before and after recruitment maneuver<br>Other: US guided lung recruitment maneuver<br>* Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome guided by lung ultrasound<br>|
| Other: Non US guided lung recruitment<br>Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group. | Other: lung recruitment maneuver<br>* Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome<br>Other: tracheal IL-6 level<br>* tracheal IL-6 level was measured before and after recruitment maneuver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung ultrasound and diagnosis of respiratory distress syndrome | Forty four preterm neonates diagnosed with respiratoey distress syndrome had lung ultrasound assessment . Its grading was N=normal (presence of lung sliding with A lines or fewer than two isolated B lines) , B1=multiple well-defined B lines , B2=multiple coalescent B lines , C=Consolidation. | 1 year | 
| Lung ultrasound and recruitment maneuver | An ultrasound re aeration score is calculated from changes in the ultrasound pattern of each region examined during the recruitment maneuver (N,B1,B2,C). | 1 year | 
| Lung ultrasound guided recruitment maneuver and the period of oxygen dependency. | The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring oxygen therapy in the NICU . | 1 year | 
| Lung ultrasound guided recruitment maneuver and the total number of NICU admission days. | The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring admission in the NICU . | 1 year | 
| Lung ultrasound guided recruitment maneuver and its relation to lung inflammation | Tracheal aspirate IL-6 is measured initially before recruitment maneuver, and on the third day if still ventilated ,or before extubation if done earlier than the third day. | 1 year |