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
- Respiratory Distress Syndrome, Newborn
- Interventions
- Other: lung recruitment maneuverOther: tracheal IL-6 levelOther: US guided lung recruitment maneuver
- Registration Number
- NCT04107090
- Lead Sponsor
- Ain Shams University
- Brief Summary
This work is designed to:
1. Evaluate the efficacy of lung ultrasonography in detecting opening and closing lung pressures in ventilated preterm neonates with respiratory distress syndrome.
2. 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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Gestational age ≤ 36 weeks.
- In need for invasive mechanical ventilation for RDS according to Downes Score .
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description US guided lung recruitment US guided lung recruitment maneuver Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography. Non US guided lung recruitment lung recruitment maneuver Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group. US guided lung recruitment tracheal IL-6 level Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography. Non US guided lung recruitment tracheal IL-6 level Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group. US guided lung recruitment lung recruitment maneuver Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography.
- Primary Outcome Measures
Name Time Method Lung ultrasound guided recruitment maneuver and the total number of NICU admission days. 1 year The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring admission in the NICU .
Lung ultrasound and recruitment maneuver 1 year 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).
Lung ultrasound guided recruitment maneuver and the period of oxygen dependency. 1 year The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring oxygen therapy in the NICU .
Lung ultrasound and diagnosis of respiratory distress syndrome 1 year 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.
Lung ultrasound guided recruitment maneuver and its relation to lung inflammation 1 year 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ain Shams Univeristy
🇪🇬Cairo, Egypt