Lung Ultrasound as a Predictor for Successful Extubation in Preterm Infants

NCT05628753 | Completed

• 1 other identifier: Bio ID 1451
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

unit (NICU); however prolonged MV is known to be associated with serious complications including ventilator associated pneumonia, blood stream infections, bronchopulmonary dysplasia (BPD) and periventricular leukomalacia. At the same time, extubation failure increases morbidities and mortality. Hatch et al (2016) in their prospective study on 162 infants described adverse events in 40% of intubations and severe complications including need for CPR in 9%. Reintubations are frequently associated with hypoxemia, bradycardia, fluctuations in blood pressures and cerebral perfusion. Each intubation attempt increases the risk of traumatic injury to the upper airway, lung atelectasis and infections. Thus, there is a clear need to establish objective criteria that would help avoid extubation failure and the need for reintubation. In recent years, a new imaging application has been introduced in neonatal practice-lung ultrasound (LUS), an accurate and reliable technique for the lung evaluation. LUS is safe, non-ionizing, easy to operate, and low-cost tool. The evaluation of lungs is performed in real-time, on the bedside and without anesthetic drugs. Lung aeration could be assessed in dynamics without extra radiation to the infant. Ultrasound findings combined with clinical information could be used for the prognosis of successful extubation in premature infants.

Conditions

no Conditions

Keywords

Lung ultrasound; Prematurity; RDS; Mechanical ventilation; Extubation

Outcome Measures

Primary Outcomes (2)

• lung aeration before and after extubation by comparing LUS indexes

  30 minutes

• re-intubation within 12, 36 or 72 hours

  72 hours

Interventions

Lung Ultrasound (LUS) DIAGNOSTIC_TEST

LUS performed 30 mins prior to and 120 minutes after planned extubation with a linear high frequency probe longitudinal approach was used in all three zones Repeated third scan will be done prior to re-intubation (if required) The ultrasound total execution cut-off time expected to be less than 5 minutes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Invasively ventilated infants born before 32 weeks of gestational age

You may qualify if:

• Invasively ventilated infants born at less than 32 weeks of gestational age were included at the time of their first extubation

You may not qualify if:

• infants born after 32 weeks of gestational age

Sponsors & Collaborators

• Royal University Hospital, Saskatoon: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 29, 2022
• Study Start: July 14, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CA (1)