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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Newborn
• Intervention / Treatment: Other: lung recruitment maneuver; Other: tracheal IL-6 level; Other: US guided lung recruitment maneuver

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11517
    • Ain shams univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 2 days (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Gestational age ≤ 36 weeks.
2. In need for invasive mechanical ventilation for RDS according to Downes Score .

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: US guided lung recruitment; Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography.	Other: lung recruitment maneuver; Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome; Other: tracheal IL-6 level; tracheal IL-6 level was measured before and after recruitment maneuver; Other: US guided lung recruitment maneuver; Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome guided by lung ultrasound
OTHER: Non US guided lung recruitment; 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; Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome; Other: tracheal IL-6 level; tracheal IL-6 level was measured before and after recruitment maneuver

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2018
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ACTUAL): May 20, 2019

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (ACTUAL): September 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: Lung Ultrasound

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No