Changes of the right diaphragmatic kinetics following tracheal extubation in the newborn by using pulsed tissue Doppler imaging: a pilot study. (ET RD-PTDI neo)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Other

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  To ascertain whether early signs of diaphragmatic dysfunction predictive of tracheal extubation failure (defined as the need to restore mechanical ventilation within 72 hours of extubation due to respiratory failure) can be identified with bedside ultrasound.
• Data analysis plan:
  The Shapiro-Wilk test will be used to assess normal distribution of variables, Chi-square test with Yate’s continuity correction and Fisher’s exact test for comparisons of categorical variables, and Mann–Whitney’s U for non-normally distributed continuous variables. Relationships between variables will be tested using the Spearman rho correlation coefficient analysis. Statistical analyses will be performed using IBMSPSS VR version 26.0 (IBM Corp. Armonk, NY, USA, 2019), and a two-sided P value < 0.05 will be considered significant.