Actively Recruiting

Age: 2Days - 6Months
All Genders
ID05865977

Diaphragmatic Tissue Doppler Imaging During a Spontaneous Breathing Trial to Predict Extubation Failure in Preterm Infants

Led by Wang Jianhui · Updated on 2024-07-16

100

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of diaphragmatic tissue Doppler imaging (dTDI) to study diaphragmatic excursion velocity in premature infants during a spontaneous breathing trial (SBT). The goal is to understand how diaphragm movement relates to the success or failure of weaning from mechanical ventilation. This observational study focuses on preterm infants supported by invasive mechanical ventilation for at least 48 hours and aims to predict extubation failure, which is a critical issue linked to diaphragmatic dysfunction. During the study, dTDI is performed at the end of the SBT to assess the diaphragm's excursion, velocity, and acceleration in both inspiration and expiration phases. Patients are grouped based on their success or failure during weaning: those who require re-intubation within 48 hours after passing the SBT are considered to have failed weaning, while those who do not require invasive ventilation within 48 hours after extubation are considered successful. The main focus is on measuring changes in diaphragmatic displacement velocity over an average of 20 minutes. Participants are monitored for various outcomes including diaphragmatic acceleration and deceleration, gas exchange parameters like arterial carbon dioxide tension, pH, and oxygen tension, as well as respiratory severity scores. The study closely observes the number of patients experiencing weaning failure within 48 hours. Data collection occurs during the SBT and throughout the 48-hour post-extubation period, with parental consent required for participation. The study is led by Wang Jianhui and is ongoing until December 25, 2024.

CONDITIONS

Brief Title

dTDI During a SBT to Predict Extubation Failure in Preterm Infants

Who Can Participate

Age: 2Days - 6Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Premature infants with gestational age less than 32 weeks
  • Supported by invasive mechanical ventilation for at least 48 hours
  • Meet all indications for extubation including cough or vomiting due to spontaneous breathing and sputum aspiration
  • Ventilator parameters in recent 24 hours: mean airway pressure less than 8 cmH2O, respiratory rate less than 30 times per minute, fraction of inspired oxygen less than 30%
  • Arterial blood gas values: pH greater than 7.25, arterial carbon dioxide tension less than 60 mmHg, base excess less than 8 mmol/L, oxygen saturation greater than 90%
  • Successful spontaneous breathing trial
  • Parents or legal guardians have signed informed consent to attend the study
Not Eligible

You will not qualify if you...

  • Accidental extubation
  • Chest CT or bronchoscopy during hospitalization indicating congenital airway dysplasia
  • Complex congenital heart disease
  • Congenital metabolic diseases or neuromuscular diseases
  • Severe brain injury
  • Surgical mechanical ventilation
  • Giving up before extubation
  • Pneumothorax or pleural effusion
  • No consent signed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 20 minutes

Participants undergo diaphragmatic tissue Doppler imaging (dTDI) at the end of a spontaneous breathing trial to assess diaphragmatic function.

1 visit (in-person)

Long-term Monitoring

Duration - 48 hours

Participants are observed for 48 hours after extubation to determine weaning success or failure based on clinical outcomes.

Continuous monitoring during hospitalization

Trial Site Locations

Total: 1 location

1

Children's hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400014

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Research Team

J

Jianhui Wang, Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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