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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

Not Applicable
Completed
Conditions
Respiratory Distress Syndrome, Newborn
Interventions
Other: lung recruitment maneuver
Other: tracheal IL-6 level
Other: 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
Inclusion Criteria
  1. Gestational age ≤ 36 weeks.
  2. In need for invasive mechanical ventilation for RDS according to Downes Score .
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Exclusion Criteria
  • excluded:

    1. Major upper or lower airway anomalies.
    2. Significant congenital anomalies including cardiac, abdominal or respiratory.
    3. Surgical cases
    4. Inborn errors of metabolism
    5. Early onset sepsis.
    6. Meconium aspiration syndrome.
    7. Hypoxic ischemic encephalopathy.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
US guided lung recruitmentUS guided lung recruitment maneuverGroup A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography.
Non US guided lung recruitmentlung recruitment maneuverGroup B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.
US guided lung recruitmenttracheal IL-6 levelGroup A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography.
Non US guided lung recruitmenttracheal IL-6 levelGroup B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.
US guided lung recruitmentlung recruitment maneuverGroup A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography.
Primary Outcome Measures
NameTimeMethod
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 maneuver1 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 syndrome1 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 inflammation1 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
NameTimeMethod

Trial Locations

Locations (1)

Ain Shams Univeristy

🇪🇬

Cairo, Egypt

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