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

NCT04107090 | Completed DMC

• 1 other identifier: Lung Ultrasound
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This work is designed to:

1. 1.Evaluate the efficacy of lung ultrasonography in detecting opening and closing lung pressures in ventilated preterm neonates with respiratory distress syndrome.
2. 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.

Conditions

Respiratory Distress Syndrome, Newborn

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

US guided lung recruitment

EXPERIMENTAL

Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography.

Other: lung recruitment maneuver; Other: tracheal IL-6 level; Other: US guided lung recruitment maneuver

Non US guided lung recruitment

OTHER

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; Other: tracheal IL-6 level

Interventions

lung recruitment maneuver OTHER

Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome

Non US guided lung recruitment; US guided lung recruitment

tracheal IL-6 level OTHER

tracheal IL-6 level was measured before and after recruitment maneuver

Non US guided lung recruitment; US guided lung recruitment

US guided lung recruitment maneuver OTHER

Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome guided by lung ultrasound

US guided lung recruitment

Eligibility Criteria

• Age: 1 Hour - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Univeristy

Cairo, 11517, Egypt

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 27, 2019
• Study Start: January 20, 2018
• Primary Completion: March 1, 2019
• Study Completion: May 20, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

EG (1)